Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01642004 | — | Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint Randomization until 199 deaths, up to November 2014, approximately 25 months | Docetaxel | 113 Participants |
| Nivolumab | 86 Participants | |||
| NCT01642004 | — | Overall Survival (OS) Rate in All Randomized Participants Randomization to 18 months post-randomization, up to June 2015 | Docetaxel | 24.3 Percent probability of OS |
| Docetaxel | 50.7 Percent probability of OS | |||
| Docetaxel | 12.5 Percent probability of OS | |||
| Nivolumab | 63.7 Percent probability of OS | |||
| Nivolumab | 42.2 Percent probability of OS | |||
| Nivolumab | 28.1 Percent probability of OS | |||
| NCT01642004 | — | Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint Randomization until 199 deaths, up to November 2014, approximately 25 months | Docetaxel | 6.01 months |
| Nivolumab | 9.23 months | |||
| NCT01668784 | Carcinoma, Renal Cell | Overall Survival (OS) at Primary Endpoint Randomization until 398 deaths, up to May 2015 (approximately 30 months) | Everolimus | 19.55 months |
| Nivolumab | 25.00 months | |||
| NCT01673867 CheckMate057 | — | Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint Randomization until 413 deaths, up to March 2015 (approximately 29 months) | Docetaxel | 9.36 Months |
| Nivolumab | 12.19 Months | |||
| NCT01721772 CheckMate 066 | Melanoma | Overall Survival (OS) From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months. | Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab | 10.84 Months |
| Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine | NA Months | |||
| NCT01721772 CheckMate 066 | Melanoma | Overall Survival (OS) Rate From randomization to 6 months and or to 12 months | Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab | 71.8 Percentage of participants |
| Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab | 42.1 Percentage of participants | |||
| Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine | 84.1 Percentage of participants | |||
| Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine | 72.9 Percentage of participants | |||
| NCT01844505 | Melanoma | Overall Survival (OS) From randomization to date of death (Assessed up to September 2016, approximately 39 months) | Ipilimumab | 19.98 months |
| Ipilimumab | 19.94 months | |||
| Nivolumab | NA months | |||
| Nivolumab | 36.93 months | |||
| Nivolumab + Ipilimumab | 71.92 months | |||
| Nivolumab + Ipilimumab | NA months | |||
| NCT01844505 | Melanoma | Progression Free Survival (PFS) From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months) | Ipilimumab | 2.89 months |
| Ipilimumab | 2.86 months | |||
| Nivolumab | 6.93 months | |||
| Nivolumab | 6.87 months | |||
| Nivolumab + Ipilimumab | 11.50 months | |||
| Nivolumab + Ipilimumab | 11.50 months | |||
| NCT01844505 | Melanoma | Rate of Overall Survival 24 months | Ipilimumab | 0.45 Probability of survival at Time T |
| Ipilimumab | 0.82 Probability of survival at Time T | |||
| Ipilimumab | 0.67 Probability of survival at Time T | |||
| Nivolumab | 0.85 Probability of survival at Time T | |||
| Nivolumab | 0.74 Probability of survival at Time T | |||
| Nivolumab | 0.59 Probability of survival at Time T | |||
| Nivolumab + Ipilimumab | 0.73 Probability of survival at Time T | |||
| Nivolumab + Ipilimumab | 0.64 Probability of survival at Time T | |||
| Nivolumab + Ipilimumab | 0.86 Probability of survival at Time T | |||
| NCT01844505 | Melanoma | Rate of Progression-Free Survival 24 months | Ipilimumab | 0.12 Percentage of participants |
| Ipilimumab | 0.18 Percentage of participants | |||
| Ipilimumab | 0.28 Percentage of participants | |||
| Nivolumab | 0.52 Percentage of participants | |||
| Nivolumab | 0.43 Percentage of participants | |||
| Nivolumab | 0.37 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.43 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.63 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.50 Percentage of participants | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Overall Survival (OS) for Cohort 2 Time between the date of randomization and the date of death due to any cause (up to up to 17Jun2019, approximately 5 years) | Cohort 2: Arm B | 10.05 Months |
| Cohort 2: Arm N3 | 9.77 Months | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d From first dose to 30 days post last dose (up to approximately 34 months). | Cohort 1: Arm N1+I3 | 10.0 Percentage of participants |
| Cohort 1: Arm N1+I3 | 70.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 40.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 50.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 20.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 25.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 58.1 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 22.6 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 6.5 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 12.9 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 20.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 13.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 33.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 26.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 28.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 50.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 10.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 17.9 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 21.4 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 35.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 25.0 Percentage of participants | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months) | Cohort 1: Arm N1+I3 | 0 Percentage of participants |
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 16.7 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 33.3 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 66.7 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 50.0 Percentage of participants | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d From first dose to 30 days post last dose (up to approximately 34 months). | Cohort 1: Arm N1+I3 | 0 Percentage of participants |
| Cohort 1: Arm N1+I3 | 60.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 40.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 35.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 15.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 45.2 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 16.1 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.2 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 35.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 10.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 14.3 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 32.1 Percentage of participants | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d From first dose to 30 days post last dose (up to approximately 34 months). | Cohort 1: Arm N1+I3 | 30.0 Percentage of participants |
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 15.8 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.3 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.3 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.2 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 6.5 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 22.6 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 12.9 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 10.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 18.5 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 7.4 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 14.8 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| NCT02017717 CheckMate 143 | Glioblastoma | Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d From first dose to 30 days post last dose (up to approximately 34 months). | Cohort 1: Arm N1+I3 | 60.0 Percentage of participants |
| Cohort 1: Arm N1+I3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 60.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 50.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.3 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 15.8 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 31.6 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 31.6 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 30.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 10.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 43.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 33.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 23.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 13.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 6.7 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 20.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 13.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 40.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 13.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 10.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 40.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 7.4 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 22.2 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 18.5 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 29.6 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 18.5 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 33.3 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 7.4 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 7.4 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 7.4 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| NCT02041533 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival in Participants With PD-L1 Expression >= 5% From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) | Investigator Choice of Chemotherapy | 5.88 Months |
| Nivolumab | 4.21 Months | |||
| NCT02066636 CheckMate153 | Carcinoma, Non-Small-Cell Lung | The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5) From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) | Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants |
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 1 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 3 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 1 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 1 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort A: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 1 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 1 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Cohort B: Nivolumab Monotherapy (Post-Randomization) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 19 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 18 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 4 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 1 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 20 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 6 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 15 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 4 Participants | |||
| Nivolumab Monotherapy (Pre-Randomized) | 0 Participants | |||
| NCT02105636 | Squamous Cell Carcinoma of Head and Neck | Overall Survival (OS) From date of randomization to date of death (Up to approximately 18 months) | Investigators Choice | 5.06 Months |
| Nivolumab 3mg/kg | 7.49 Months | |||
| NCT02224781 | Melanoma | 2-year Overall Survival (OS) assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry | Arm A (Immunotherapy) | 0.683 Proportion of participants |
| Arm B (BRAF Inhibitor Therapy) | 0.541 Proportion of participants | |||
| NCT02231749 | Carcinoma, Renal Cell | Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months) | Nivolumab + Ipilimumab | 41.6 percentage of participants |
| Sunitinib | 26.5 percentage of participants | |||
| NCT02231749 | Carcinoma, Renal Cell | Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months) | Nivolumab + Ipilimumab | NA months |
| Sunitinib | 25.95 months | |||
| NCT02231749 | Carcinoma, Renal Cell | Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months) | Nivolumab + Ipilimumab | 11.56 months |
| Sunitinib | 8.38 months | |||
| NCT02388906 CheckMate 238 | Melanoma | Recurrence-free Survival (RFS) up to 36 months | Ipilimumab 10 mg/kg | 24.08 Months |
| Ipilimumab 10 mg/kg | 24.15 Months | |||
| Nivolumab 3 mg/kg | 61.14 Months | |||
| Nivolumab 3 mg/kg | 52.37 Months | |||
| NCT02477826 CheckMate 227 | Carcinoma, Non-Small-Cell Lung | Overall Survival From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks) | Part 1-Arm A: Nivolumab | 15.70 months |
| Part 1-Arm B: Nivo + Ipi | 17.12 months | |||
| Part 1-Arm C: Chemotherapy | 14.88 months | |||
| Part 1-Arm D: Nivo + Ipi | 17.45 months | |||
| Part 1-Arm F: Chemotherapy | 12.19 months | |||
| Part 1-Arm G: Nivo + Chemo | 15.21 months | |||
| Part 2 - Arm H: Nivolumab + Chemotherapy | 18.27 months | |||
| Part 2 - Arm I: Chemotherapy | 14.72 months | |||
| Part 3 - Arm K: Chemotherapy | 15.11 months | |||
| Part 3 -Arm J: Nivolumab + Ipilimumab | 20.99 months | |||
| NCT02477826 CheckMate 227 | Carcinoma, Non-Small-Cell Lung | Progression-Free Survival Per BICR From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | Part 1-Arm A: Nivolumab | 4.17 months |
| Part 1-Arm B: Nivo + Ipi | 5.06 months | |||
| Part 1-Arm C: Chemotherapy | 5.55 months | |||
| Part 1-Arm D: Nivo + Ipi | 4.90 months | |||
| Part 1-Arm F: Chemotherapy | 4.70 months | |||
| Part 1-Arm G: Nivo + Chemo | 5.55 months | |||
| Part 2 - Arm H: Nivolumab + Chemotherapy | 8.34 months | |||
| Part 2 - Arm I: Chemotherapy | 5.52 months | |||
| Part 3 - Arm K: Chemotherapy | 5.49 months | |||
| Part 3 -Arm J: Nivolumab + Ipilimumab | 5.78 months | |||
| NCT02481830 CheckMate331 | Lung Neoplasms | Overall Survival (OS) OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months | Group A | 7.46 Months |
| Group B | 8.38 Months | |||
| NCT02538666 CheckMate 451 | Lung Neoplasms | Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months) | Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg | 9.17 Months |
| Global Placebo | 9.56 Months | |||
| NCT02569242 | Esophageal Neoplasms | Overall Survival ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. | Active Comparator Arm (Docetaxel/Paclitaxel) | 8.4 months |
| Nivolumab Arm | 10.9 months | |||
| NCT02576509 | Carcinoma, Hepatocellular | Overall Survival (OS) time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months) | Nivolumab 240 mg | 16.39 Months |
| Sorafenib 400 mg | 14.69 Months | |||
| NCT02599402 CheckMate 401 | Melanoma | Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events From first dose to 30 days after last dose (up to approximately 37 months) | Nivolumab + Ipilimumab Acral | 0 Participants |
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 1 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 1 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 1 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 Participants | |||
| Nivolumab + Ipilimumab Acral | 1 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 5 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 6 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 1 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 1 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 5 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 1 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 1 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 43 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 20 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 6 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 8 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 56 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 57 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 31 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 9 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 75 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 79 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 58 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 7 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 7 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 4 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 4 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 5 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 2 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 2 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 1 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 3 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 17 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 9 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 1 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 7 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 6 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 1 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 4 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 6 Participants | |||
| Nivolumab + Ipilimumab Other | 1 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 6 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 11 Participants | |||
| Nivolumab + Ipilimumab Total | 1 Participants | |||
| Nivolumab + Ipilimumab Total | 58 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 82 Participants | |||
| Nivolumab + Ipilimumab Total | 1 Participants | |||
| Nivolumab + Ipilimumab Total | 10 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 35 Participants | |||
| Nivolumab + Ipilimumab Total | 1 Participants | |||
| Nivolumab + Ipilimumab Total | 83 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 7 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| NCT02613507 CheckMate 078 | Carcinoma, Non-Small-Cell Lung | Median Overall Survival From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months) | Docetaxel | 9.63 Months |
| Nivolumab | 11.99 Months | |||
| NCT02613507 CheckMate 078 | Carcinoma, Non-Small-Cell Lung | Overall Survival Rate From first dose to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months) | Docetaxel | 38.8 percentage |
| Docetaxel | 64.8 percentage | |||
| Nivolumab | 49.7 percentage | |||
| Nivolumab | 72.4 percentage | |||
| NCT02617589 CheckMate 498 | Brain Neoplasms | Overall Survival (OS) up to 3 years | Nivolumab + Radiation Therapy | 13.40 Months |
| Temozolomide + Radiation Therapy | 14.88 Months | |||
| NCT02632409 CheckMate 274 | — | Disease Free Survival (DFS) approximately up to 48 months | Nivolumab | 20.76 Months |
| Placebo | 10.84 Months | |||
| NCT02632409 CheckMate 274 | — | Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population approximately up to 48 months | Nivolumab | NA Months |
| Placebo | 8.41 Months | |||
| NCT02667587 CheckMate548 | Brain Neoplasms | Overall Survival (OS) From randomization to date of death (up to approximately 4.5 years) | Radiotherapy, Temozolomide Plus Nivolumab | 28.91 Months |
| Radiotherapy, Temozolomide Plus Nivolumab | 31.34 Months | |||
| Radiotherapy, Temozolomide Plus Placebo | 32.99 Months | |||
| Radiotherapy, Temozolomide Plus Placebo | 32.07 Months | |||
| NCT02667587 CheckMate548 | Brain Neoplasms | Progression-free Survival (PFS) Determined by BICR From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years) | Radiotherapy, Temozolomide Plus Nivolumab | 10.64 Months |
| Radiotherapy, Temozolomide Plus Placebo | 10.32 Months | |||
| NCT02713867 CheckMate 384 | Lung Neoplasms | Progression Free Survival Rate (PFSR) at 12 Months At 12 Months | Nivolumab 240mg | 0.55 Proportion of Participants |
| Nivolumab 480mg | 0.53 Proportion of Participants | |||
| NCT02713867 CheckMate 384 | Lung Neoplasms | Progression Free Survival Rate (PFSR) at 6 Months At 6 Months | Nivolumab 240mg | 0.79 Proportion of Participants |
| Nivolumab 480mg | 0.76 Proportion of Participants | |||
| NCT02714218 | Melanoma | The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months) | Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV | 45.5 Percentage of participants |
| Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV | 32.8 Percentage of participants | |||
| NCT02726581 CheckMate 602 | Multiple Myeloma | Progression Free Survival (PFS) From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month) | Arm A: N-Pd | 8.38 Months |
| Arm B: Pd | 7.33 Months | |||
| NCT02741570 CheckMate 651 | Head and Neck Neoplasms | Overall Survival (OS) in All Randomized Participants From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | EXTREME Regimen | 13.50 Months |
| Nivolumab + Ipilimumab | 13.90 Months | |||
| NCT02741570 CheckMate 651 | Head and Neck Neoplasms | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | EXTREME Regimen | 14.59 Months |
| Nivolumab + Ipilimumab | 17.58 Months | |||
| NCT02743494 CheckMate 577 | — | Disease-free Survival (DFS) From randomization to the date of recurrence or death (up to approximately 46 months) | Nivolumab | 22.41 Months |
| Placebo | 11.04 Months | |||
| NCT02768558 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) From registration to study termination. Maximum follow-up was 14.9 months. | Nivolumab | 2 Participants |
| Placebo | 5 Participants | |||
| NCT02785952 | — | Overall Survival From date of registration to maximum of 3 years or death | Arm I (Nivolumab, Ipilimumab) | 10 months |
| Arm II (Nivolumab) | 11 months | |||
| NCT02864251 CheckMate722 | Carcinoma, Non-Small-Cell Lung | Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR) From randomization to the date of first documented tumor progression or death (approximately 58 months) | Arm A: Nivolumab Plus Platinum-doublet Chemotherapy | 5.59 Months |
| Arm B: Nivolumab Plus Ipilimumab | 1.54 Months | |||
| Arm C: Platinum Doublet Chemotherapy | 5.45 Months | |||
| NCT02872116 CheckMate649 | Stomach Neoplasms | Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 From the date of randomization up to the date of death, up to approximately 17 months | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 14.39 Months |
| Arm 2a: Chemotherapy (XELOX or FOLFOX) | 11.10 Months | |||
| NCT02872116 CheckMate649 | Stomach Neoplasms | Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months) | Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX) | 7.69 Months |
| Arm 2a: Chemotherapy (XELOX or FOLFOX) | 6.05 Months | |||
| NCT02899299 CheckMate743 | Mesothelioma | Overall Survival (OS) From randomization to the date of death (Up to 40 Months) | Treatment A | 18.07 Months |
| Treatment B | 14.09 Months | |||
| NCT02905266 | Melanoma | Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks) | Fixed Ratio Combination | 15.1 Percent of Participants |
| Sequential Combination | 17.0 Percent of Participants | |||
| NCT02998528 CheckMate 816 | Carcinoma, Non-Small-Cell Lung | Event-Free Survival (EFS) From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) | Arm B: Platinum Doublet Chemo | 20.80 Months |
| Arm B: Platinum Doublet Chemo | 21.06 Months | |||
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 31.57 Months | |||
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 59.60 Months | |||
| NCT02998528 CheckMate 816 | Carcinoma, Non-Small-Cell Lung | Pathologic Complete Response (pCR) Rate From randomization up to a median of 30 months after randomization. | Arm B: Platinum Doublet Chemo | 4 Participants |
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 43 Participants | |||
| NCT03036098 CheckMate901 | — | Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | Treatment 3 | 21.72 Months |
| Treatment 4 | 18.86 Months | |||
| NCT03036098 CheckMate901 | — | Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | Treatment 1 | 19.06 Months |
| Treatment 2 | 13.21 Months | |||
| NCT03036098 CheckMate901 | — | Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months) | Treatment 1 | 16.30 Months |
| Treatment 2 | 14.36 Months | |||
| NCT03036098 CheckMate901 | — | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months) | Treatment 3 | 7.92 Months |
| Treatment 4 | 7.56 Months | |||
| NCT03055013 | Carcinoma, Renal Cell | Recurrence-free Survival (RFS) Rate at 5 Years Assessed at 20 weeks, 40 weeks, then every 3 months for patients <2 years from randomization, then every 6 months for 3 years | Arm A (Nephrectomy + Nivolumab) | 0.63 proportion of participants |
| Arm B (Nephrectomy Only) | 0.605 proportion of participants | |||
| NCT03068455 CheckMate 915 | Melanoma | Recurrence-free Survival (RFS) - All Randomized Participants From randomization to Primary Completion Date (up to approximately 3 years) | Arm A: Nivo + Ipi | NA Months |
| Arm B: Nivo | NA Months | |||
| NCT03068455 CheckMate 915 | Melanoma | Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1% From randomization to Primary Completion Date (up to approximately 3 years) | Arm A: Nivo + Ipi | 33.15 Months |
| Arm B: Nivo | 27.63 Months | |||
| NCT03092674 | Leukemia, Myeloid, Acute | Overall Survival (OS) (Phase II) Day of registration on study until death from any cause, assessed for up to 5 years | Azacitidine | 6.2 months |
| Azacitidine + Nivolumab | 5.2 months | |||
| Azacitidine +Midostaurin | 7.4 months | |||
| NCT03138499 CheckMate 812 | Hodgkin Disease | Progression Free Survival (PFS) From randomization to date of death, or disease progression (up to approximately 45 months) | Brentuximab Vedotin (BV) | 7.93 Months |
| Nivolumab + Brentuximab Vedotin (BV) | 14.32 Months | |||
| NCT03138512 CheckMate 914 | Carcinoma, Renal Cell | Disease-Free Survival (DFS) by BICR - Treatment Part A and B From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months) | Treatment Part A: Nivo + Ipi | NA Months |
| Treatment Part A: Placebo | NA Months | |||
| Treatment Part B: Nivo | NA Months | |||
| Treatment Part B: Placebo | NA Months | |||
| NCT03141177 CheckMate 9ER | Carcinoma, Renal Cell | Progression Free Survival (PFS) From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months) | Treatment A | 16.59 Months |
| Treatment C | 8.31 Months | |||
| NCT03143153 CheckMate 648 | — | Overall Survival (OS) in Participants With Tumor Cell PD-L1 From the date of randomization to up to the date of death (up to approximately 20 months) | Arm A: Nivolumab + Ipilimumab | 13.70 Months |
| Arm B: Nivolumab + Chemotherapy | 15.44 Months | |||
| Arm C: Chemotherapy | 9.07 Months | |||
| NCT03143153 CheckMate 648 | — | Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1 From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months) | Arm A: Nivolumab + Ipilimumab | 4.04 Months |
| Arm B: Nivolumab + Chemotherapy | 6.93 Months | |||
| Arm C: Chemotherapy | 4.44 Months | |||
| NCT03195491 CheckMate870 | Carcinoma, Non-Small-Cell Lung | Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events From first dose up to 100 days post dose, up to approximately 36 months | Non-HBV Participants | 7 Participants |
| Non-HBV Participants | 2 Participants | |||
| Non-HBV Participants | 5 Participants | |||
| Non-HBV Participants | 8 Participants | |||
| Non-HBV Participants | 2 Participants | |||
| NCT03215706 CheckMate 9LA | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) From date of randomization to date of death (assessed up to October 2019, approximately 23 months) | Treatment A | 15.80 Months |
| Treatment A | 14.13 Months | |||
| Treatment B | 10.96 Months | |||
| Treatment B | 10.74 Months | |||
| NCT03329846 | Melanoma | Number of Participants Experiencing Adverse Events From first dose to 30 days following last dose (up to approximately 25 months) | Nivolumab | 0 Participants |
| Nivolumab | 0 Participants | |||
| Nivolumab | 3 Participants | |||
| Nivolumab | 7 Participants | |||
| Nivolumab | 0 Participants | |||
| Nivolumab | 9 Participants | |||
| Nivolumab | 0 Participants | |||
| Nivolumab + BMS-986205 | 0 Participants | |||
| Nivolumab + BMS-986205 | 10 Participants | |||
| Nivolumab + BMS-986205 | 1 Participants | |||
| Nivolumab + BMS-986205 | 1 Participants | |||
| Nivolumab + BMS-986205 | 3 Participants | |||
| Nivolumab + BMS-986205 | 0 Participants | |||
| Nivolumab + BMS-986205 | 9 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants Who Experienced Death 100 days | Arm A (Cohort 1) | 2 Participants |
| Arm B (Cohort 1) | 2 Participants | |||
| Arm C (Cohort 2) | 2 Participants | |||
| Arm D (Cohort 2) | 1 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Abnormality in Specific Liver Tests 30 days | Arm A (Cohort 1) | 0 Participants |
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 2 Participants | |||
| Arm A (Cohort 1) | 1 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Abnormality in Specific Thyroid Tests 30 Days | Arm A (Cohort 1) | 4 Participants |
| Arm A (Cohort 1) | 1 Participants | |||
| Arm A (Cohort 1) | 4 Participants | |||
| Arm A (Cohort 1) | 3 Participants | |||
| Arm A (Cohort 1) | 5 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 5 Participants | |||
| Arm A (Cohort 1) | 4 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 1 Participants | |||
| Arm B (Cohort 1) | 2 Participants | |||
| Arm B (Cohort 1) | 1 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 3 Participants | |||
| Arm B (Cohort 1) | 3 Participants | |||
| Arm B (Cohort 1) | 1 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 1 Participants | |||
| Arm C (Cohort 2) | 4 Participants | |||
| Arm C (Cohort 2) | 16 Participants | |||
| Arm C (Cohort 2) | 6 Participants | |||
| Arm C (Cohort 2) | 9 Participants | |||
| Arm C (Cohort 2) | 13 Participants | |||
| Arm C (Cohort 2) | 7 Participants | |||
| Arm C (Cohort 2) | 1 Participants | |||
| Arm C (Cohort 2) | 2 Participants | |||
| Arm C (Cohort 2) | 7 Participants | |||
| Arm C (Cohort 2) | 1 Participants | |||
| Arm D (Cohort 2) | 1 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 1 Participants | |||
| Arm D (Cohort 2) | 1 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 13 Participants | |||
| Arm D (Cohort 2) | 13 Participants | |||
| Arm D (Cohort 2) | 2 Participants | |||
| Arm D (Cohort 2) | 7 Participants | |||
| Arm D (Cohort 2) | 4 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Adverse Event (AE) 30 Days | Arm A (Cohort 1) | 12 Participants |
| Arm B (Cohort 1) | 10 Participants | |||
| Arm C (Cohort 2) | 27 Participants | |||
| Arm D (Cohort 2) | 24 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Adverse Event Leading to Discontinuation 30 Days | Arm A (Cohort 1) | 2 Participants |
| Arm B (Cohort 1) | 3 Participants | |||
| Arm C (Cohort 2) | 8 Participants | |||
| Arm D (Cohort 2) | 4 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Adverse Event Leading to Dose Modification 30 Days | Arm A (Cohort 1) | 0 Participants |
| Arm B (Cohort 1) | 0 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Immune-mediated Adverse Event (IMAE) 100 days | Arm A (Cohort 1) | 0 Participants |
| Arm A (Cohort 1) | 1 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm C (Cohort 2) | 3 Participants | |||
| Arm C (Cohort 2) | 4 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With an Serious Adverse Event (SAE) 30 days | Arm A (Cohort 1) | 5 Participants |
| Arm B (Cohort 1) | 5 Participants | |||
| Arm C (Cohort 2) | 9 Participants | |||
| Arm D (Cohort 2) | 6 Participants | |||
| NCT03349710 | Squamous Cell Carcinoma of Head and Neck | Number of Participants With Select Adverse Events 30 Days | Arm A (Cohort 1) | 1 Participants |
| Arm A (Cohort 1) | 1 Participants | |||
| Arm A (Cohort 1) | 4 Participants | |||
| Arm A (Cohort 1) | 0 Participants | |||
| Arm A (Cohort 1) | 2 Participants | |||
| Arm A (Cohort 1) | 7 Participants | |||
| Arm B (Cohort 1) | 7 Participants | |||
| Arm B (Cohort 1) | 3 Participants | |||
| Arm B (Cohort 1) | 2 Participants | |||
| Arm B (Cohort 1) | 3 Participants | |||
| Arm B (Cohort 1) | 0 Participants | |||
| Arm B (Cohort 1) | 1 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm C (Cohort 2) | 3 Participants | |||
| Arm C (Cohort 2) | 2 Participants | |||
| Arm C (Cohort 2) | 13 Participants | |||
| Arm C (Cohort 2) | 12 Participants | |||
| Arm C (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 11 Participants | |||
| Arm D (Cohort 2) | 1 Participants | |||
| Arm D (Cohort 2) | 0 Participants | |||
| Arm D (Cohort 2) | 6 Participants | |||
| Arm D (Cohort 2) | 3 Participants | |||
| NCT03414983 CheckMate 9X8 | Colorectal Neoplasms | Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) From randomization to up to the date of the first documented progression (up to 16 months) | Arm A: NIV+mFOLFOX+BEV | 11.86 Months |
| Arm B: mFOLFOX+BEV | 11.93 Months | |||
| NCT03470922 RELATIVITY-047 | Melanoma | Progression Free Survival (PFS) From randomization to date of first documented tumor progression or death (up to approximately 33 months) | Arm A: Relatlimab + Nivolumab | 10.12 Months |
| Arm B: Nivolumab | 4.63 Months | |||
| NCT03522246 ATHENA | Neoplasms | Combination Therapy Arm A and Arm B: Investigator Assessed PFS From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | Arm A: Rucaparib + Nivolumab | 15.0 months |
| Arm B: Rucaparib + Placebo | 20.2 months | |||
| NCT03522246 ATHENA | Neoplasms | Monotherapy Arm B and Arm D: Investigator Assessed PFS From randomization until disease progression (up to the primary data analysis at approximately 39 months) | Arm B: Rucaparib + Placebo | 20.2 months |
| Arm D: Placebo + Placebo | 9.2 months | |||
| NCT03522246 ATHENA | Neoplasms | Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) From randomization until disease progression (up to the primary data analysis at approximately 39 months) | Arm B: Rucaparib + Placebo | 28.7 months |
| Arm D: Placebo + Placebo | 11.3 months | |||
| NCT03635983 | Melanoma | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) From date of randomization to disease progression (Up to 37 months) | Bempegaldesleukin + Nivolumab | 27.7 Percentage of participants |
| Nivolumab | 36.0 Percentage of participants | |||
| NCT03635983 | Melanoma | Overall Survival (OS) From date of randomization to date of death (Up to 37 months) | Bempegaldesleukin + Nivolumab | 29.67 Months |
| Nivolumab | 28.88 Months | |||
| NCT03635983 | Melanoma | Progression-free Survival (PFS) Per Blinded Independent Central Review (BICR) From date of randomization to disease progression, or death, whichever comes first (Up to 37 months) | Bempegaldesleukin + Nivolumab | 4.17 Months |
| Nivolumab | 4.99 Months | |||
| NCT03729245 | Carcinoma, Renal Cell | Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC Approximately 32 months | Combination of Bempegaldesleukin + Nivolumab | 73 Participants |
| Combination of Bempegaldesleukin + Nivolumab | 59 Participants | |||
| Sunitinib or Cabozantinib | 79 Participants | |||
| Sunitinib or Cabozantinib | 109 Participants | |||
| NCT03729245 | Carcinoma, Renal Cell | Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC Approximately 32 months | Combination of Bempegaldesleukin + Nivolumab | 29 months |
| Combination of Bempegaldesleukin + Nivolumab | NA months | |||
| Sunitinib or Cabozantinib | NA months | |||
| Sunitinib or Cabozantinib | NA months | |||
| NCT03906071 SAPPHIRE | — | Overall Survival (OS) From randomization date to date of death due to any cause (Up to approximately 44 months) | Docetaxel | 10.58 Months |
| Nivolumab and Sitravatinib | 12.22 Months | |||
| NCT03907488 | Hodgkin Disease | Progression Free Survival (PFS) From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years | Arm I (Chemotherapy, Nivolumab, Radiation) | 41 Participants |
| Arm II (Chemotherapy, Brentuximab Vedotin, Radiation) | 81 Participants | |||
| NCT03937219 COSMIC-313 | Carcinoma, Renal Cell | Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC) Up to 32 months | Cabozantinib + Nivolumab + Ipilimumab | NA months |
| Placebo + Nivolumab + Ipilimumab | 11.30 months | |||
| NCT03952585 | Squamous Cell Carcinoma of Head and Neck | Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression) From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported. | Arm I (Standard RT + Cisplatin) | 99.1 percentage of participants |
| Arm I (Standard RT + Cisplatin) | 98.1 percentage of participants | |||
| Arm II (Reduced RT+ Cisplatin) | 96.4 percentage of participants | |||
| Arm II (Reduced RT+ Cisplatin) | 88.6 percentage of participants | |||
| Arm III (Reduced RT + Nivolumab) | 90.3 percentage of participants | |||
| Arm III (Reduced RT + Nivolumab) | 96.6 percentage of participants | |||
| NCT04008030 CheckMate 8HW | Colorectal Neoplasms | Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months) | Arm A - Nivolumab Monotherapy | 39.26 Months |
| Arm B - Nivolumab + Ipilimumab | NA Months | |||
| NCT04008030 CheckMate 8HW | Colorectal Neoplasms | Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months) | Arm B - Nivolumab + Ipilimumab | NA Months |
| Arm C - Investigator's Choice Chemotherapy | 5.85 Months | |||
| NCT04025879 | Carcinoma, Non-Small-Cell Lung | Event-Free Survival (EFS) by BICR From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months) | Nivolumab + SOC Chemotherapy | NA Months |
| Placebo + SOC Chemotherapy | 18.43 Months | |||
| NCT04026412 CheckMate73L | Carcinoma, Non-Small-Cell Lung | Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR) From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months) | Arm A:Nivo + CCRT/Nivo + Ipi | 16.69 months |
| Arm C: CCRT/Durva | 15.64 months | |||
| NCT04099251 CheckMate76K | Melanoma | Recurrence Free Survival (RFS) From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months) | Nivolumab | NA Months |
| Placebo | NA Months | |||
| NCT04100018 CheckMate 7DX | Prostatic Neoplasms | Overall Survival (OS) From randomization to the date of death from any cause (Up to approximately 31 months) | Nivolumab + Docetaxel + Prednisone | 18.73 months |
| Placebo + Docetaxel + Prednisone | 18.92 months | |||
| NCT04100018 CheckMate 7DX | Prostatic Neoplasms | Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3) from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months) | Nivolumab + Docetaxel + Prednisone | 9.43 months |
| Placebo + Docetaxel + Prednisone | 8.74 months | |||
| NCT04109066 CheckMate 7FL | Neoplasms | Pathological Complete Response (pCR) Rate Up to approximately 37 months | Arm A | 24.5 Percentage of participants |
| Arm B | 13.8 Percentage of participants | |||
| NCT04209114 | Urinary Bladder Neoplasms | Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care From randomization up to first EFS event (up to approximately 30 months) | Arm A: Nivolumab + Bempegaldesleukin | 22.11 Months |
| Arm C: Standard of Care | 15.18 Months | |||
| NCT04209114 | Urinary Bladder Neoplasms | Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months) | Arm A: Nivolumab + Bempegaldesleukin | 10.8 Percentage of participants |
| Arm C: Standard of Care | 2.5 Percentage of participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants Who Died From first dose and 100 days after last dose of study therapy (up to approximately 27 months) | NIVO+IPI+TACE | 2 Participants |
| NIVO+TACE | 2 Participants | |||
| TACE | 0 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Adverse Events From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 9 Participants |
| NIVO+TACE | 9 Participants | |||
| TACE | 8 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Adverse Events Leading to Study Drug Discontinuation From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 3 Participants |
| NIVO+TACE | 1 Participants | |||
| TACE | 1 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 3 Participants |
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 5 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 5 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 5 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 5 Participants |
| NIVO+IPI+TACE | 5 Participants | |||
| NIVO+IPI+TACE | 5 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 4 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 5 Participants | |||
| NIVO+TACE | 4 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 1 Participants | |||
| TACE | 1 Participants | |||
| TACE | 4 Participants | |||
| TACE | 3 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 3 Participants | |||
| TACE | 0 Participants | |||
| TACE | 5 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Serious Adverse Events (SAEs) From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 7 Participants |
| NIVO+TACE | 6 Participants | |||
| TACE | 2 Participants | |||
| NCT04340193 CheckMate 74W | Liver Neoplasms | Number of Participants With Worst Grade (Grade 3/4) Laboratory Results From first dose and 30 days after last dose of study therapy (up to approximately 25 months) | NIVO+IPI+TACE | 1 Participants |
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 4 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+IPI+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
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| NCT04396860 | Gliosarcoma | Progression-free Survival (PFS) (Phase II) From randomization to date of progression, death, or last known follow-up, whichever occurs first. Maximum follow-up time was 19.3 months. | Arm I (Radiation Therapy, Temozolomide) | 8.5 months |
| Arm II (Radiation Therapy, Ipilimumab, Nivolumab) | 7.7 months | |||
| NCT04458909 | Nasopharyngeal Carcinoma | Overall Survival (OS) Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years. | Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | 8 Participants |
| Arm II (Gemcitabine, Cisplatin / Carboplatin) | 4 Participants | |||
| NCT04637594 IMAGINE | Carcinoma, Transitional Cell | Overall Survival (OS) Rate at 12 Months 12 months | Arm A (Immune Checkpoint Inhibitor) | 0 percentage of participants |
| Arm B (Immune Checkpoint Inhibitor) | 0 percentage of participants | |||
| NCT04695977 | Melanoma | Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Up to approximately 39 months | CMP-001 and Nivolumab | 44 Percentage of participants |
| Nivolumab Monotherapy | 73 Percentage of participants | |||
| NCT05002569 RELATIVITY-098 | Melanoma | Recurrence Free Survival (RFS) Approximately 27.5 Months | Treatment 1 | NA Months |
| Treatment 2 | 33.84 Months | |||
| NCT05297565 CheckMate-6GE | Melanoma | Number of Participants With Adverse Events From first dose to 100 days post last dose (Approximately up to 14 Months) | Arm A | 0 Participants |
| Arm A | 0 Participants | |||
| Arm A | 6 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 8 Participants | |||
| Arm B | 2 Participants | |||
| NCT05297565 CheckMate-6GE | Melanoma | Number of Participants With Serious Adverse Events From first dose to 100 days post last dose (Approximately up to 14 Months) | Arm A | 0 Participants |
| Arm A | 0 Participants | |||
| Arm A | 0 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 0 Participants | |||
| NCT05297565 CheckMate-6GE | Melanoma | Number of Participants With Treatment Related Adverse Events From first dose to 100 days post last dose (Approximately up to 14 Months) | Arm A | 0 Participants |
| Arm A | 6 Participants | |||
| Arm A | 0 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 2 Participants | |||
| Arm B | 8 Participants | |||
| NCT05297565 CheckMate-6GE | Melanoma | Number of Participants With Treatment Related Serious Adverse Events From first dose to 100 days post last dose (Approximately up to 14 Months) | Arm A | 0 Participants |
| Arm A | 0 Participants | |||
| Arm A | 0 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 0 Participants | |||
| Arm B | 0 Participants |