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 |
|---|---|---|---|---|
| NCT00324155 | Melanoma | Overall Survival (OS) Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months | Ipilimumab and Dacarbazine | 11.17 Months |
| Placebo and Dacarbazine | 9.07 Months | |||
| NCT00636168 | — | Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years. | Ipilimumab 10mg/kg | 234 Participants |
| Placebo | 294 Participants | |||
| NCT00636168 | — | Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population At years 1, 2, and 3 | Ipilimumab 10mg/kg | 46.48 Percentage of participants |
| Ipilimumab 10mg/kg | 51.45 Percentage of participants | |||
| Ipilimumab 10mg/kg | 63.50 Percentage of participants | |||
| Placebo | 34.79 Percentage of participants | |||
| Placebo | 43.83 Percentage of participants | |||
| Placebo | 56.13 Percentage of participants | |||
| NCT00636168 | — | Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years. | Ipilimumab 10mg/kg | 26.09 months |
| Placebo | 17.05 months | |||
| NCT00861614 | Prostatic Neoplasms | Overall Survival (OS) Date of randomization to date of death | Ipilimumab + Radiotherapy | 11.04 months |
| Placebo + Radiotherapy | 10.02 months | |||
| NCT00861614 | Prostatic Neoplasms | Overall Survival Rate Date of randomization to date of death | Ipilimumab + Radiotherapy | 46.5 percentage of participants |
| Ipilimumab + Radiotherapy | 7.9 percentage of participants | |||
| Ipilimumab + Radiotherapy | 25.2 percentage of participants | |||
| Ipilimumab + Radiotherapy | 10.1 percentage of participants | |||
| Ipilimumab + Radiotherapy | 15.3 percentage of participants | |||
| Placebo + Radiotherapy | 3.3 percentage of participants | |||
| Placebo + Radiotherapy | 2.7 percentage of participants | |||
| Placebo + Radiotherapy | 40.8 percentage of participants | |||
| Placebo + Radiotherapy | 16.6 percentage of participants | |||
| Placebo + Radiotherapy | 7.9 percentage of participants | |||
| NCT01057810 | Prostatic Neoplasms | Overall Survival (OS) Time Randomization until death from any cause, up to April 2015, approximately 57 months | Ipilimumab | 28.65 months |
| Placebo | 29.73 months | |||
| NCT01274338 | Melanoma | 5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI]) Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Arm A (HIP) | 0.70 proportion of participants |
| Arm B (HDI) | 0.65 proportion of participants | |||
| NCT01274338 | Melanoma | 5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP]) Assessed every 3 months for 2 years, then every 6 months for years 3-5 | Arm B (HDI) | 0.67 proportion of participants |
| Arm C (LIP) | 0.72 proportion of participants | |||
| NCT01274338 | Melanoma | Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI]) Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Arm A (HIP) | 3.9 years |
| Arm B (HDI) | 2.4 years | |||
| NCT01274338 | Melanoma | Recurrence-free Survival (RFS; Arm B [HDI] vs. Arm C [LIP]) Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years | Arm B (HDI) | 2.5 years |
| Arm C (LIP) | 4.5 years | |||
| NCT01285609 | — | Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start) | Ipilimumab With Paclitaxel/Carboplatin | 13.37 months |
| Placebo With Paclitaxel/Carboplatin | 12.42 months | |||
| NCT01450761 | Small Cell Lung Carcinoma | Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy Randomization until date of death, up to March 2015, approximately 38 months | Ipilimumab and Platinum/Etoposide | 10.97 months |
| Placebo and Platinum/Etoposide | 10.94 months | |||
| NCT01515189 | Melanoma | Overall Survival (OS) Approximately 48 months (assessed up to February 2016) | Ipilimumab (10 mg/kg) | 15.70 months |
| Ipilimumab (3 mg/kg) | 11.53 months | |||
| 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 | 2.86 months |
| Ipilimumab | 2.89 months | |||
| Nivolumab | 6.87 months | |||
| Nivolumab | 6.93 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 | 0.67 Probability of survival at Time T | |||
| Ipilimumab | 0.82 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 | 0.86 Probability of survival at Time T | |||
| Nivolumab + Ipilimumab | 0.64 Probability of survival at Time T | |||
| Nivolumab + Ipilimumab | 0.73 Probability of survival at Time T | |||
| NCT01844505 | Melanoma | Rate of Progression-Free Survival 24 months | Ipilimumab | 0.12 Percentage of participants |
| Ipilimumab | 0.28 Percentage of participants | |||
| Ipilimumab | 0.18 Percentage of participants | |||
| Nivolumab | 0.52 Percentage of participants | |||
| Nivolumab | 0.43 Percentage of participants | |||
| Nivolumab | 0.37 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.50 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.63 Percentage of participants | |||
| Nivolumab + Ipilimumab | 0.43 Percentage of participants | |||
| NCT01866319 | Melanoma | Percentage of Participants With Overall Survival (OS) at 12 Months Month 12 | Ipilimumab | 58.2 Percentage of participants |
| Pembrolizumab Q2W | 74.1 Percentage of participants | |||
| Pembrolizumab Q3W | 68.4 Percentage of participants | |||
| NCT01866319 | Melanoma | Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014) | Ipilimumab | 2.8 Months |
| Pembrolizumab Q2W | 5.5 Months | |||
| Pembrolizumab Q3W | 4.1 Months | |||
| 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 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 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 1b: Arm N3+I1 | 25.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 20.0 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 | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 58.1 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 12.9 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 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 20.0 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 A Cohort 1d: Arm N3+RT | 13.3 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 | 50.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 10.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 28.6 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0 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 | 17.9 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 | 50.0 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 | |||
| 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 | 20.0 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 | 60.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 40.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 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 | 5.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 35.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 15.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.2 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 45.2 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 16.1 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 | 3.3 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 B Cohort 1c: Arm N3+RT+TMZ | 35.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 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 | 3.6 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.6 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 | 32.1 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 | |||
| 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 | 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 | 30.0 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 | 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 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 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 5.3 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 | 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 | |||
| Cohort 1b: Arm N3+I1 | 0.0 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 | 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 | 0.0 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 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 | 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 | 10.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 3.3 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 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 | 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 | 3.7 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 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 | |||
| 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 | |||
| 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 | 20.0 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 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N1+I3 | 30.0 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 N3 | 50.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 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 | 20.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 10.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 0.0 Percentage of participants | |||
| Cohort 1: Arm N3 | 30.0 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 | 10.5 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 31.6 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 15.8 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 | 0.0 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 31.6 Percentage of participants | |||
| Cohort 1b: Arm N3+I1 | 10.5 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 10.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 33.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 43.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 3.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 6.7 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 13.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 20.0 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 23.3 Percentage of participants | |||
| Part A Cohort 1c: Arm N3+RT+TMZ | 30.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 13.3 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 | 10.0 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 | 3.3 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part A Cohort 1d: Arm N3+RT | 16.7 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 22.2 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 | 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 | 0.0 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 11.1 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 18.5 Percentage of participants | |||
| Part B Cohort 1c: Arm N3+RT+TMZ | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 0.0 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 29.6 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 | 33.3 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 3.7 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 7.4 Percentage of participants | |||
| Part B Cohort 1d: Arm N3+RT | 18.5 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 | |||
| 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 | |||
| NCT02279732 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy Approximately 43 months post study start | Ipi + PAC/CAR | NA months |
| Placebo + PAC/CAR | NA 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 | 52.37 Months | |||
| Nivolumab 3 mg/kg | 61.14 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 | |||
| NCT02506153 | Melanoma | Overall Survival (OS) 5 years after last randomization | FDA Approved Regimen (SOC) | 76 percentage of participants |
| MK-3475 (Pembrolizumab) | 82 percentage of participants | |||
| 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 | |||
| NCT02545075 | Melanoma | Two-Years Survival Rate 24 months | Dacarbazine (250 mg/m2) | 34.09 Percentage of Participants |
| Ipilimumab (3 mg/kg) | 33.98 Percentage of Participants | |||
| 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 | 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 | 1 Participants | |||
| Nivolumab + Ipilimumab Acral | 0 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 Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 1 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 5 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 5 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 1 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 6 Participants | |||
| Nivolumab + Ipilimumab Brain Metastasis | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 6 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 8 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 20 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 1 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 57 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 43 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 0 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 56 Participants | |||
| Nivolumab + Ipilimumab Cutaneous | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 79 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 7 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 1 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 31 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 | 75 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS0-1 | 58 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 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 | 1 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 | 7 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab ECOG PS2 | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 3 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 1 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 | 5 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 2 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Mucosal | 0 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 0 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 | 0 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 Ocular/Uveal | 1 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 6 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 7 Participants | |||
| Nivolumab + Ipilimumab Ocular/Uveal | 9 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 | 11 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 4 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 1 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Other | 6 Participants | |||
| Nivolumab + Ipilimumab Other | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 83 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 1 Participants | |||
| Nivolumab + Ipilimumab Total | 0 Participants | |||
| Nivolumab + Ipilimumab Total | 58 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 | 7 Participants | |||
| Nivolumab + Ipilimumab Total | 0 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 | |||
| 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 | |||
| 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 | 59.60 Months | |||
| Arm C: Nivo 360 mg + Platinum Doublet Chemo | 31.57 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 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| NCT03302234 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) Up to approximately 32 months (through data cut-off date: 01 Sep 2020) | Pembrolizumab + Ipilimumab | 21.4 Months |
| Pembrolizumab + Placebo | 21.9 Months | |||
| NCT03302234 | Carcinoma, Non-Small-Cell Lung | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) Up to approximately 32 months (through data cut-off date 01 Sep 2020) | Pembrolizumab + Ipilimumab | 8.2 Months |
| Pembrolizumab + Placebo | 8.4 Months | |||
| NCT03445533 | Melanoma | Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1 Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). | Arm A: Ipilimumab | 1 Participants |
| Arm A: Ipilimumab | 110 Participants | |||
| Arm A: Ipilimumab | 45 Participants | |||
| Arm A: Ipilimumab | 20 Participants | |||
| Arm A: Ipilimumab | 67 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 61 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 89 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 1 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 20 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 67 Participants | |||
| NCT03445533 | Melanoma | Summary of Overall Survival OS is measured from the date of randomization to the date of death from any cause (up to 36 months). | Arm A: Ipilimumab | 77 Participants |
| Arm A: Ipilimumab | 166 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 165 Participants | |||
| Arm B: IMO-2125 Plus Ipilimumab | 73 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 | |||
| 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 | |||
| 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 | |||
| 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 | 1 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 5 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 5 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 5 Participants | |||
| TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 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 | 0 Participants | |||
| NIVO+IPI+TACE | 2 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 3 Participants | |||
| NIVO+IPI+TACE | 5 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 4 Participants | |||
| NIVO+TACE | 5 Participants | |||
| NIVO+TACE | 2 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 4 Participants | |||
| TACE | 0 Participants | |||
| TACE | 4 Participants | |||
| TACE | 0 Participants | |||
| TACE | 5 Participants | |||
| TACE | 0 Participants | |||
| TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 3 Participants | |||
| TACE | 0 Participants | |||
| TACE | 3 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 | 2 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+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 | 2 Participants | |||
| NIVO+IPI+TACE | 0 Participants | |||
| NIVO+IPI+TACE | 4 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 | 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 | 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 | 1 Participants | |||
| NIVO+IPI+TACE | 0 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 | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 0 Participants | |||
| NIVO+TACE | 1 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 | |||
| NIVO+TACE | 0 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 | |||
| 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 | 0 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 | |||
| NIVO+TACE | 0 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 | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 3 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 2 Participants | |||
| TACE | 0 Participants | |||
| TACE | 1 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| TACE | 0 Participants | |||
| 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 |