Primary completion· ClinicalTrials.gov
Cabozantinib In Combo With NIVO + IPI In Advanced NCCRCC
Nivolumab History and Updates
250 events · 2005 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
154
FDA Approvals
2
Label Revisions
5,223
Trial Milestones
10
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Nivolumab since 2005, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (198)
2026
- Results postedNivolumab (RegoNivo) Misses OS Endpoint in Advanced Gastro-Oesophageal Cancer· Jun 10, 2026
- Results postedNivolumab Melanoma Trial Terminated; No Clinical Benefit Observed· Jun 3, 2026
- Results postedNivolumab Combination Trial for Metastatic Melanoma Posts ORR Results· May 29, 2026
- Results postedNivolumab + Cabozantinib Phase 1 for Advanced Cancer + HIV Shows No DLTs, 63%…· May 28, 2026
- Results postedNivolumab + Docetaxel + ADT Trial Posts mHSPC Biomarker Cohort Results· May 27, 2026
- Results postedNivolumab + Ibrutinib Shows Lower PFS, OS in HNSCC Phase 2 Trial· May 22, 2026
- Results postedNivolumab Shows 6.7-Month PSA-PFS in Recurrent dMMR Prostate Cancer· May 15, 2026
- Results postedNivolumab Combo Shows Higher Response in Relapsed/Refractory CD30+ Lymphoma· May 12, 2026
- Results postedNivolumab Combination Therapy Safety Results Posted for Pancreatic Cancer· May 11, 2026
- Results postedNivolumab Trial Results Posted for High-Risk Recurrent Prostate Cancer· May 8, 2026
- Results postedNivolumab Adjuvant Therapy Shows 71.4% Disease-Free Survival in Head and Neck…· May 6, 2026
- Results postedNivolumab with Paclitaxel Shows Shorter PFS in Soft Tissue Sarcoma Trial· May 5, 2026
- Results postedNivolumab/Cabozantinib Combo Improves PFS, OS in Endometrial Cancer· Apr 29, 2026
- Results postedNivolumab Monotherapy and Combination Show Activity in Anal Canal Cancer· Apr 22, 2026
- Results postedNivolumab Phase II Trial Shows Limited Benefit in Colorectal Cancer· Apr 22, 2026
- Results postedNivolumab: Melanoma Patients Prefer Subcutaneous Administration in Phase 2 Trial· Apr 9, 2026
- Results postedNivolumab Combinations Report Few Grade 3/4 Lab Abnormalities in Advanced Cancer· Apr 6, 2026
- Results postedNivolumab Trial Results Posted for Ovarian, Fallopian Tube, Peritoneal Cancer· Apr 1, 2026
- Results postedNivolumab Shows Higher Median OS Than Lomvastomig in Esophageal Squamous Cell…· Mar 27, 2026
- FDA approval (supplemental)Nivolumab Receives FDA Supplemental Approval for Efficacy· Mar 20, 2026
- Results postedNivolumab + Ipilimumab + Radiation for HPV+ Oropharyngeal Carcinoma Shows…· Mar 17, 2026
- Primary completionNivolumab: Sagittarius Trial for Stage II/III Colon Cancer Primary Completion· Mar 1, 2026
- Results postedNivolumab Phase 1 Trial Shows No Dose-Limiting Toxicities in MDS/AML· Feb 27, 2026
- Primary completionNivolumab Hepatocellular Carcinoma Trial Completes Primary Endpoint Study· Feb 27, 2026
- Results postedNivolumab Plus Chemotherapy Shows High Pathologic Response in Resectable NSCLC· Feb 20, 2026
- Results postedNivolumab-based Immunotherapy Shows Improved 2-Year OS in BRAFV600 Melanoma· Feb 18, 2026
- Results postedNivolumab + ALT-803 Defines Safety in Advanced NSCLC Trial· Feb 17, 2026
- Primary completionNivolumab Phase 3 MIBC Trial Reaches Primary Completion· Feb 16, 2026
- Results postedNivolumab + Nal-Irinotecan Shows 4.1-Month PFS in Biliary Tract Cancer· Feb 13, 2026
- Results postedNivolumab in mCRC Shows Longer Duration of Response in Phase 2 Trial· Feb 13, 2026
- Results postedTrial results posted: NCT05921760· Feb 12, 2026
- Results postedNivolumab + EO2401 Trial for Adrenocortical Carcinoma Terminated, Safety…· Jan 30, 2026
- Results postedNivolumab Monotherapy and Combination Show Disease Control in Meningioma· Jan 26, 2026
- Primary completionNivolumab Biosimilar Study in Melanoma Reaches Primary Completion· Jan 23, 2026
- Results postedNivolumab Combination Shows 65% PFS in HPV-Related Head and Neck Cancer· Jan 22, 2026
- Results postedNivolumab Combination Therapy Safety Data Posted for Advanced Cancers· Jan 20, 2026
- Primary completionNivolumab Phase 3 Trial in Renal Cell Carcinoma Completes Primary Study· Jan 20, 2026
- Results postedNivolumab + Chemoradiation Shows 100% ORR in Nasopharyngeal Carcinoma· Jan 12, 2026
- Results postedNivolumab Combinations for SCCHN Show 33.3% Disease Control in Prior…· Jan 8, 2026
- Results postedNivolumab Plus Relatlimab Melanoma Trial Terminated· Jan 8, 2026
- Results postedNivolumab & Relatlimab Phase 1/2 Trial Posts Safety Data for Solid Tumors· Jan 6, 2026
- Pivotal publicationNivolumab Added to Cisplatin-RT for Head and Neck Squamous Cell Carcinoma· Jan 1, 2026
- Pivotal publicationNivolumab 9-Year Data for Resected Stage III/IV Melanoma Published· Jan 1, 2026
2025
- Primary completionNivolumab Phase 3 Trial Completes Primary Study for Advanced Melanoma· Dec 31, 2025
- Results postedNivolumab: Safety Data Posted for Advanced Liver Cancer Trial· Dec 24, 2025
- Results postedNivolumab Plus Ipilimumab Shows Responses in Salivary Gland Cancer Trial· Dec 18, 2025
- Results postedNivolumab Combination Trial for Advanced Solid Tumors Posts Safety Results· Dec 17, 2025
- Results postedNivolumab + Duvelisib in Melanoma: No DLTs, Low Overall Response Rate in Phase…· Dec 17, 2025
- Results postedNivolumab Shows Improvement in Bronchial Dysplasia in High-Risk Smokers· Dec 12, 2025
- Results postedNivolumab Combo Shows 664-Day Median DOR in Neuroendocrine Tumors· Dec 12, 2025
- Results postedNivolumab Combination Therapy Shows Low DLTs in Advanced Lung/Liver Cancers· Dec 3, 2025
- Results postedNivolumab Combination Trial in Colorectal Cancer Posts Safety Data· Dec 3, 2025
- Results postedNivolumab Triplet Shows 1.0 mcg/kg/day MTD, Zero DLTs in Refractory Cancers· Dec 3, 2025
- FDA approval (supplemental)Opdivo Qvantig (Nivolumab) Receives FDA Supplemental Efficacy Approval· Nov 24, 2025
- Results postedNivolumab in IDH-Mutant Gliomas: Lower 6-Month PFS in Hypermutated Phenotype· Nov 24, 2025
- Results postedNivolumab Combination Trial for Advanced Solid Tumors Posts Safety Data· Nov 18, 2025
- Results postedNivolumab Trial for Oral Cavity Cancer Shows 4 Pathological Responses· Nov 12, 2025
- Results postedNivolumab + TG4010 Phase 2 Lung Cancer Trial Results Posted· Nov 10, 2025
- Results postedNivolumab Shows Improved Overall Survival in Acute Myeloid Leukemia· Nov 6, 2025
- Results postedNivolumab + Ipilimumab Shows High Objective Response in Colon Cancer Trial· Nov 6, 2025
- Results postedNivolumab Phase 2 Trial for Relapsed Hematologic Malignancies Shows Limited…· Nov 3, 2025
- Results postedNivolumab for Recurrent IDH Mutant Gliomas Shows 9% Overall Response Rate· Nov 3, 2025
- Results postedNivolumab, Cabozantinib, Ipilimumab Combination Shows 0.1 ORR in Thyroid Cancer· Oct 31, 2025
- Results postedNivolumab Plus Chemotherapy Improves PFS in Stage IV NSCLC Trial· Oct 30, 2025
- FDA approval (supplemental)Opdivo Qvantig (Nivolumab) Receives Supplemental FDA Approval for Efficacy· Oct 27, 2025
- FDA approval (supplemental)Opdivo Qvantig Supplemental Application Approved by FDA for Efficacy· Oct 27, 2025
- Results postedNivolumab/BMS-986253 Combo Shows Higher ORR in HCC Trial· Oct 16, 2025
- Results postedNivolumab Combination Therapy Shows 9.4 Months PFS in Metastatic NSCLC· Oct 14, 2025
- Primary completionNivolumab Phase 3 Trial for Advanced Gastric Cancer Reaches Primary Completion· Oct 14, 2025
- Primary completionNivolumab Phase 3 NSCLC Trial Reaches Primary Completion, Status Terminated· Oct 13, 2025
- Results postedNivolumab Combination Shows Better PFS, ORR in tRCC Trial· Oct 10, 2025
- Results postedNivolumab Combination Trial Posts Adverse Event Data in Solid Tumors· Oct 9, 2025
- Results postedNivolumab Combination Trial for Advanced Solid Tumors Reports Minimal DLTs· Oct 3, 2025
- Primary completionNivolumab Phase 3 Trial for Renal Cell Carcinoma Reaches Primary Completion· Sep 30, 2025
- Results postedNivolumab/Ipilimumab Phase 1 Trial in HIV-Associated Cancers Shows Tolerability· Sep 23, 2025
- Results postedNivolumab + Ipilimumab Improves PFS in dMMR/MSI-H Metastatic Colorectal Cancer…· Sep 22, 2025
- Results postedNivolumab Combination Trial for Advanced Cancer Posts Safety Results· Sep 18, 2025
- Results postedNivolumab Combination Improves Overall Survival in Urothelial Cancer· Sep 18, 2025
- Results postedNivolumab Trial for Bladder Cancer Terminates, Safety Data Posted· Sep 16, 2025
- Results postedNivolumab/Ipilimumab Combination Safety Profile in Chinese Solid Tumor Patients· Sep 15, 2025
- Results postedNivolumab Combination Trial Shows Improved PFS in Advanced Renal Cell Carcinoma· Sep 10, 2025
- Results postedNivolumab Monotherapy Outperforms Combination in Advanced Melanoma Trial· Sep 5, 2025
- Results postedNivolumab Combination Trial for Metastatic Ovarian Cancer Terminated· Aug 12, 2025
- Results postedNivolumab Glioblastoma Trial: Adverse Events Reported in Phase 1 Study· Aug 12, 2025
- Results postedNivolumab Combination Trial in Stage IV Pancreatic Cancer Posts Initial Results· Aug 6, 2025
- Results postedNivolumab Combo Shows 1 CR in Relapsed/Refractory Hodgkin Lymphoma Trial· Aug 6, 2025
- Primary completionNivolumab + Relatlimab SC Bioequivalence Trial in Melanoma Completes Primary…· Aug 4, 2025
- Primary completionNivolumab + XL092 Trial in Non-Clear Cell RCC Reaches Primary Completion· Jul 31, 2025
- Primary completionNivolumab Phase 3 Trial in Clear Cell RCC Reaches Primary Completion· Jul 29, 2025
- Results postedNivolumab: Safety Data Posted for Myeloma, Lymphoma Trial· Jul 25, 2025
- Results postedNivolumab Combinations Show Varied Outcomes in Stage 3 NSCLC Trial· Jul 24, 2025
- Results postedNivolumab Combinations Show Low Functional Cure Rates in Chronic Hepatitis B…· Jul 24, 2025
- Results postedNivolumab with CV301 Vaccination Shows Higher ORR in Metastatic CRC Trial· Jul 22, 2025
- Results postedNivolumab Monotherapy Shows 23% Objective Response in Bladder Cancer· Jul 22, 2025
- Results postedNivolumab Plus Axitinib Shows 10% ORR in Refractory Advanced Melanoma· Jul 15, 2025
- Primary completionNivolumab-relatlimab Phase 3 Trial for Metastatic Colorectal Cancer Terminated· Jul 14, 2025
- Results postedNivolumab + Ipilimumab for Untreated Advanced Kidney Cancer Safety Profile…· Jul 11, 2025
- Results postedNivolumab Shows Variable Responses in Advanced Renal Cell Carcinoma· Jul 10, 2025
- Primary completionNivolumab Phase 3 Trial in Gastro-Oesophageal Cancer Reaches Primary Completion· Jul 9, 2025
- Primary completionOpdivo Phase 3 Trial for Esophageal SCC Reaches Primary Completion· Jun 30, 2025
- Results postedNivolumab Combination Shows Improved 2-Year OS in Head and Neck Cancer· Jun 26, 2025
- Results postedNivolumab: Terminated Prostate Cancer Trial Results Posted· Jun 25, 2025
- Results postedNivolumab in Ovarian Cancer: Combination with Rucaparib Reduces PFS· Jun 24, 2025
- Primary completionNivolumab Phase 3 Trial for Advanced Pleural Mesothelioma Completes Primary…· Jun 20, 2025
- Results postedNivolumab Combination Therapy Trial for Advanced Cancers Posts Safety Data· Jun 19, 2025
- Results postedNivolumab Regimen Shows Improved PFS vs Brentuximab Vedotin in Stage III-IV…· Jun 12, 2025
- Results postedNivolumab mCRPC Trial Terminated: Mixed Safety & PSA Response Data· Jun 10, 2025
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· May 23, 2025
- Results postedNivolumab with De-Escalated Chemo Shows Similar PFS in HPV-Negative HNSCC· May 11, 2025
- Results postedNivolumab Trial Shows High 2-Year PFS and OS in Head and Neck Cancer· May 6, 2025
- Results postedNivolumab Combination Achieves 93% 1-Year RFS in Melanoma Trial· May 6, 2025
- Results postedNivolumab in HPV+ Oropharyngeal Cancer: Reduced RT Arms Miss PFS Endpoint· May 2, 2025
- Results postedNivolumab Trial for Unresectable Stage III NSCLC Terminated Early· Apr 30, 2025
- Results postedNivolumab & BMS-986253 Trial Results for Hormone-Sensitive Prostate Cancer· Apr 29, 2025
- Results postedNivolumab Combination Trial for Advanced Solid Tumors Posts Adverse Event Counts· Apr 24, 2025
- Results postedNivolumab/Ipilimumab with Rituximab/Hyaluronidase Reduces Melanoma irAEs· Apr 22, 2025
- Results postedNivolumab Combinations for Advanced Solid Tumors: Adverse Event Counts Posted· Apr 20, 2025
- Results postedNivolumab Combo Shows Improved PFS in Metastatic Colorectal Cancer· Apr 16, 2025
- Results postedNivolumab NSCLC Combination Therapy Trial Terminated· Apr 16, 2025
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Approval for Efficacy· Apr 11, 2025
- FDA approval (supplemental)Nivolumab Receives FDA Supplemental Approval for Efficacy on April 8, 2025· Apr 8, 2025
- Results postedNivolumab Combination Trial in Relapsed/Refractory cHL Reports ORR of 15%· Apr 3, 2025
- Results postedNivolumab + CMP-001 in Advanced Melanoma: Phase 2 Trial Terminated with 11.4%…· Apr 2, 2025
- Primary completionNivolumab Biosimilar Study ABP 206 for Resected Melanoma Completes Phase 3· Mar 26, 2025
- Results postedNivolumab, Ipilimumab, Nintedanib Combo Shows Improved OS in NSCLC· Mar 25, 2025
- Results postedNivolumab Trial for Advanced Solid Tumors, NSCLC Posts Safety Data· Mar 18, 2025
- Results postedNivolumab Plus Relatlimab Combination Improves ORR in NSCLC· Mar 18, 2025
- Results postedNivolumab + Etigilimab Shows 37.5% ORR in Cervical Carcinoma· Mar 17, 2025
- Results postedNivolumab Alone vs. Nivolumab/Ipilimumab for NSCLC Shows Similar PFS· Mar 11, 2025
- Results postedNivolumab: Phase 1 Head and Neck Cancer Trial Safety Data Posted· Mar 11, 2025
- Results postedNivolumab Combinations Show Up to 62.5% Objective Response in Advanced Cancers· Mar 7, 2025
- Results postedNivolumab Combinations Show Major Pathologic Responses in Early NSCLC· Mar 5, 2025
- Primary completionNivolumab/Ipilimumab Phase 3 Trial for Rare Sarcoma Subtype Completes Primary…· Feb 28, 2025
- Results postedNivolumab Subcutaneous vs IV Safety Assessed in Melanoma Trial· Feb 27, 2025
- Results postedNivolumab Combination Therapy Shows Improved PFS in Metastatic Melanoma· Feb 20, 2025
- Results postedNivolumab Subcutaneous Formulations Show Varied Cmax in Cancer Trial· Feb 20, 2025
- Results postedNivolumab + ABI-009 Phase 1/2 Trial for Sarcoma: MTD of 100 mg/m^2· Feb 17, 2025
- Results postedNivolumab Plus Relatlimab Shows 7.7% ORR in Metastatic Uveal Melanoma Trial· Feb 13, 2025
- Results postedNivolumab + Sorafenib Phase 2 Trial Posts Safety Data in Liver Cancer· Feb 11, 2025
- Results postedNivolumab Combo Shows High Response in Relapsed/Refractory Classic Hodgkin…· Feb 10, 2025
- Results postedNivolumab with Ivosidenib Shows Favorable Safety in IDH1 Mutant Tumors· Feb 6, 2025
- Primary completionNivolumab Combination Fails to Improve OS in Gastro-Oesophageal Cancer· Jan 14, 2025
- Pivotal publicationNivolumab Plus Ipilimumab First-Line Unresectable HCC Trial Published· Jan 1, 2025
- Pivotal publicationNivolumab Plus Ipilimumab Shows Final 10-Year Outcomes in Advanced Melanoma· Jan 1, 2025
- Pivotal publicationNivolumab Plus Ipilimumab Shows Improved Outcomes in MSI-H Colorectal Cancer· Jan 1, 2025
- Pivotal publicationNivolumab plus Chemotherapy Improves Overall Survival in Lung Cancer· Jan 1, 2025
2024
- FDA approvalOpdivo Qvantig (nivolumab and hyaluronidase-nvhy) FDA Approved as New Dosage…· Dec 27, 2024
- FDA approval (supplemental)Nivolumab (Opdivo) Receives FDA Supplemental Efficacy Approval· Oct 3, 2024
- Primary completionNivolumab Phase 3 Trial for Hodgkin Lymphoma Achieves Significant PFS (p=0.005)· Mar 31, 2024
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Mar 6, 2024
- FDA approval (supplemental)Nivolumab (Opdivo) Receives FDA Supplemental Approval for Efficacy· Jan 26, 2024
- Pivotal publicationPembrolizumab KEYNOTE-716 Trial Results Published for Adjuvant Melanoma· Jan 1, 2024
- Pivotal publicationNivolumab Perioperative Use in Resectable Lung Cancer Study Published· Jan 1, 2024
- Pivotal publicationNivolumab+AVD Pivotal Trial Results Published for Advanced Hodgkin Lymphoma· Jan 1, 2024
- Pivotal publicationNivolumab Plus Tivozanib Trial Results Published for Renal Cell Carcinoma· Jan 1, 2024
2023
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Oct 13, 2023
- Primary completionNivolumab Combo Shows Improved 2-Year OS in BRAFV600 Melanoma Phase 3 Trial· Sep 30, 2023
- Primary completionNivolumab Phase 3 in Localized Kidney Cancer: No Significant RFS or OS…· May 24, 2023
- FDA approval (supplemental)Opdivo (nivolumab) FDA Approves Supplemental Efficacy Application· Feb 15, 2023
2022
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Approval for Efficacy· Jul 14, 2022
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Approval for Efficacy· May 27, 2022
- FDA approval (supplemental)Nivolumab (Opdivo) Gains FDA Supplemental Efficacy Approval· May 11, 2022
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Mar 4, 2022
2021
- FDA approval (supplemental)Opdivo (nivolumab) Receives Supplemental FDA Approval for Efficacy· Aug 19, 2021
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Jul 15, 2021
- FDA approval (supplemental)Opdivo (Nivolumab) Gains FDA Supplemental Approval for Efficacy· May 20, 2021
- FDA approval (supplemental)FDA Approves Supplemental Efficacy Application for Opdivo (nivolumab)· Apr 16, 2021
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Jan 22, 2021
2020
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Oct 2, 2020
- FDA approval (supplemental)Opdivo (Nivolumab) FDA Approves Supplemental Application for Efficacy· Sep 18, 2020
- FDA approval (supplemental)Opdivo (Nivolumab) FDA Approves Supplemental Efficacy Application· Jun 10, 2020
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Approval for Efficacy· May 26, 2020
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· May 15, 2020
- FDA approval (supplemental)Opdivo (nivolumab) Supplemental Application for Efficacy Approved by FDA· Mar 10, 2020
2019
- Primary completionNivolumab: Lung-MAP Phase 3 Trial Reports OS Data in Squamous Cell Lung Cancer· Dec 19, 2019
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Apr 18, 2019
- FDA approval (supplemental)Opdivo (Nivolumab) Gains Supplemental FDA Efficacy Approval· Mar 7, 2019
2018
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Aug 16, 2018
- FDA approval (supplemental)Opdivo (Nivolumab) Supplemental Application for Efficacy Approved by FDA· Jul 10, 2018
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Apr 16, 2018
- FDA approval (supplemental)Opdivo (nivolumab) Receives Supplemental FDA Approval for Efficacy· Mar 5, 2018
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Feb 15, 2018
- FDA approval (supplemental)Opdivo (Nivolumab) Receives Supplemental FDA Approval for Efficacy· Jan 9, 2018
2017
- FDA approval (supplemental)Opdivo (Nivolumab) Receives Supplemental FDA Approval for Efficacy· Dec 20, 2017
- FDA approval (supplemental)Nivolumab Supplemental Application Approved by FDA for Efficacy· Sep 22, 2017
- FDA approval (supplemental)Opdivo (Nivolumab) Gains FDA Approval for Supplemental Efficacy Application· Jul 31, 2017
- Primary completionNivolumab/Ipilimumab Improves Renal Cell Carcinoma ORR, OS vs Sunitinib· Jun 26, 2017
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Approval for Efficacy· Apr 25, 2017
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Feb 2, 2017
2016
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Nov 10, 2016
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Oct 4, 2016
- FDA approval (supplemental)Opdivo (nivolumab) Receives FDA Supplemental Approval for Efficacy· Sep 13, 2016
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· May 17, 2016
- FDA approval (supplemental)Opdivo (nivolumab) Receives FDA Supplemental Approval for Efficacy· Jan 23, 2016
2015
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Nov 23, 2015
- FDA approval (supplemental)Opdivo (Nivolumab) Receives FDA Supplemental Efficacy Approval· Oct 9, 2015
- FDA approval (supplemental)Opdivo (Nivolumab) Gains FDA Supplemental Efficacy Application Approval· Sep 30, 2015
2014
- FDA approvalOpdivo (Nivolumab) Receives Initial FDA Approval as New Molecular Entity· Dec 22, 2014
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma
Primary completion· ClinicalTrials.gov
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of
Primary completion· ClinicalTrials.gov
Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-
Primary completion· ClinicalTrials.gov
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies
Primary completion· ClinicalTrials.gov
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
Primary completion· ClinicalTrials.gov
BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas
Primary completion· ClinicalTrials.gov
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Primary completion· ClinicalTrials.gov
Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma
Primary completion· ClinicalTrials.gov
Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers
Primary completion· ClinicalTrials.gov
PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma
Primary completion· ClinicalTrials.gov
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
Trial started· ClinicalTrials.gov
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Trial started· ClinicalTrials.gov
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Primary completion· ClinicalTrials.gov
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal
Primary completion· ClinicalTrials.gov
Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Can
Primary completion· ClinicalTrials.gov
Chemo-radio-immunotherapy With Nivolumab and Ipilimumab Treatment in Locally Advanced Cervical Cancer Patients
Trial started· ClinicalTrials.gov
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Primary completion· ClinicalTrials.gov
Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors
Trial started· ClinicalTrials.gov
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Med
Primary completion· ClinicalTrials.gov
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab
Primary completion· ClinicalTrials.gov
Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
Primary completion· ClinicalTrials.gov
A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study
Primary completion· ClinicalTrials.gov
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Primary completion· ClinicalTrials.gov
Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer
Trial started· ClinicalTrials.gov
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Hom
Primary completion· ClinicalTrials.gov
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
Primary completion· ClinicalTrials.gov
Study of LP-184 in Patients With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
Trial started· ClinicalTrials.gov
Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma
Primary completion· ClinicalTrials.gov
Temozolomide, Cisplatin, and Nivolumab in People With Colorectal Cancer
Primary completion· ClinicalTrials.gov
SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial
Primary completion· ClinicalTrials.gov
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
Primary completion· ClinicalTrials.gov
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
Primary completion· ClinicalTrials.gov
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
Primary completion· ClinicalTrials.gov
Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma
Primary completion· ClinicalTrials.gov
Agnostic Therapy in Rare Solid Tumors
Primary completion· ClinicalTrials.gov
Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors
Primary completion· ClinicalTrials.gov
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Primary completion· ClinicalTrials.gov
Using ctDNA to Determine Therapies for Lung Cancer
Primary completion· ClinicalTrials.gov
Nivolumab and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
Primary completion· ClinicalTrials.gov
Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy
Primary completion· ClinicalTrials.gov
Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma
Primary completion· ClinicalTrials.gov
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)
Primary completion· ClinicalTrials.gov
Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Trial started· ClinicalTrials.gov
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Primary completion· ClinicalTrials.gov
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Past events
2026
Primary completion· ClinicalTrials.gov
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Met
Trial started· ClinicalTrials.gov
Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
Results posted· ClinicalTrials.gov
RegoNivo vs Standard of Care Chemotherapy in AGOC
Trial registered· ClinicalTrials.gov
Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig
Trial registered· ClinicalTrials.gov
Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma
Primary completion· ClinicalTrials.gov
VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
Results posted· ClinicalTrials.gov
IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma
Trial registered· ClinicalTrials.gov
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Trial started· ClinicalTrials.gov
Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC
Primary completion· ClinicalTrials.gov
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
Trial started· ClinicalTrials.gov
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Primary completion· ClinicalTrials.gov
Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors
Primary completion· ClinicalTrials.gov
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Primary completion· ClinicalTrials.gov
Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy
Trial started· ClinicalTrials.gov
A Study to Test How Well Different Doses of BI 1831169 in Combination With an Anti-PD1 Antibody Are Tolerated in Japanese People With Differ
Primary completion· ClinicalTrials.gov
Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Trial started· ClinicalTrials.gov
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Primary completion· ClinicalTrials.gov
A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
Trial started· ClinicalTrials.gov
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Primary completion· ClinicalTrials.gov
Nivolumab With Ipilimumab Combined With TGFβ-15 Peptide Vaccine and Radiotherapy for Pancreatic Cancer
Primary completion· ClinicalTrials.gov
Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas
Primary completion· ClinicalTrials.gov
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Trial started· ClinicalTrials.gov
Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
Trial started· ClinicalTrials.gov
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma
Primary completion· ClinicalTrials.gov
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
A Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China
Label revision· FDA
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA can
Results posted· ClinicalTrials.gov
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Results posted· ClinicalTrials.gov
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
Results posted· ClinicalTrials.gov
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
Results posted· ClinicalTrials.gov
Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC
Label revision· FDA
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: PHESGO administration
FDA approval (supplemental)· FDA
Sponsor: GENENTECH INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GENENTECH INC. Class: Labeling.
Results posted· ClinicalTrials.gov
Nivolumab in Biochemically Recurrent dMMR Prostate Cancer
Trial started· ClinicalTrials.gov
Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
Primary completion· ClinicalTrials.gov
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
FDA approval (supplemental)· FDA
Sponsor: GENENTECH INC. Class: Efficacy.
Primary completion· ClinicalTrials.gov
CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed
FDA approval (supplemental)· FDA
Sponsor: BRISTOL-MYERS SQUIBB. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BRISTOL MYERS SQUIBB. Class: Labeling.
Results posted· ClinicalTrials.gov
Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma
FDA approval (supplemental)· FDA
Sponsor: GENENTECH INC. Class: Labeling.
Results posted· ClinicalTrials.gov
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
Trial registered· ClinicalTrials.gov
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial
FDA approval (supplemental)· FDA
Sponsor: ARGENX BV. Class: Efficacy.
Results posted· ClinicalTrials.gov
Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer
Trial registered· ClinicalTrials.gov
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alo
Results posted· ClinicalTrials.gov
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Results posted· ClinicalTrials.gov
Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma
Results posted· ClinicalTrials.gov
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC
Trial registered· ClinicalTrials.gov
A 2-part Phase 1/2 Open-label Trial on ODM-212
Trial started· ClinicalTrials.gov
Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma
Primary completion· ClinicalTrials.gov
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Trial started· ClinicalTrials.gov
Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma
Trial started· ClinicalTrials.gov
VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Trial started· ClinicalTrials.gov
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Med
Trial started· ClinicalTrials.gov
The Impact of Time-of-day-Dependent Administration of Nivolumab-Ipilimumab (ICI/ICI) Combination on Overall Survival in Adults With Advanced
Primary completion· ClinicalTrials.gov
Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca
Trial started· ClinicalTrials.gov
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Primary completion· ClinicalTrials.gov
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Primary completion· ClinicalTrials.gov
Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Trial started· ClinicalTrials.gov
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Trial started· ClinicalTrials.gov
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Primary completion· ClinicalTrials.gov
Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC
Primary completion· ClinicalTrials.gov
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Trial started· ClinicalTrials.gov
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Results posted· ClinicalTrials.gov
Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer
Trial started· ClinicalTrials.gov
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
Primary completion· ClinicalTrials.gov
Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer
Trial registered· ClinicalTrials.gov
Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL
Trial started· ClinicalTrials.gov
Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)
Trial registered· ClinicalTrials.gov
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ
Results posted· ClinicalTrials.gov
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
Results posted· ClinicalTrials.gov
A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants
Trial registered· ClinicalTrials.gov
Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers
Trial registered· ClinicalTrials.gov
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer
Trial registered· ClinicalTrials.gov
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
Trial registered· ClinicalTrials.gov
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma
Trial registered· ClinicalTrials.gov
Real-World Outcomes of First-Line Nivolumab + Ipilimumab With Chemotherapy in Non-Small Cell Lung Cancer in Poland
Trial registered· ClinicalTrials.gov
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma
Trial started· ClinicalTrials.gov
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Trial registered· ClinicalTrials.gov
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer
Primary completion· ClinicalTrials.gov
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Results posted· ClinicalTrials.gov
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatl
Trial registered· ClinicalTrials.gov
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Trial registered· ClinicalTrials.gov
Evaluation of the Efficacy and Safety of Nivolumab Neoadjuvant Treatment of Patients With Locally Advanced Oral Squamous Cell Carcinoma
Trial started· ClinicalTrials.gov
A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer
Results posted· ClinicalTrials.gov
An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread
Primary completion· ClinicalTrials.gov
Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma
Trial registered· ClinicalTrials.gov
VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Trial started· ClinicalTrials.gov
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell C
Trial registered· ClinicalTrials.gov
ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Results posted· ClinicalTrials.gov
A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib
Primary completion· ClinicalTrials.gov
Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
Trial started· ClinicalTrials.gov
Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer
Primary completion· ClinicalTrials.gov
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Trial started· ClinicalTrials.gov
Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of
Trial started· ClinicalTrials.gov
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Can
Primary completion· ClinicalTrials.gov
HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccinatio
Trial registered· ClinicalTrials.gov
Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma
Trial started· ClinicalTrials.gov
Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)
Results posted· ClinicalTrials.gov
A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous
Trial registered· ClinicalTrials.gov
Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC
Trial started· ClinicalTrials.gov
A 2-part Phase 1/2 Open-label Trial on ODM-212
Trial started· ClinicalTrials.gov
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participa
Trial registered· ClinicalTrials.gov
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Hom
Trial started· ClinicalTrials.gov
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
Trial started· ClinicalTrials.gov
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Primary completion· ClinicalTrials.gov
Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
Primary completion· ClinicalTrials.gov
Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) i
FDA approval (supplemental)· FDA
Sponsor: BRISTOL MYERS SQUIBB. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
Results posted· ClinicalTrials.gov
Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy
Trial started· ClinicalTrials.gov
Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post A
Results posted· ClinicalTrials.gov
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted
Primary completion· ClinicalTrials.gov
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carci
Trial registered· ClinicalTrials.gov
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Results posted· ClinicalTrials.gov
Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma
Trial started· ClinicalTrials.gov
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy
Trial started· ClinicalTrials.gov
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
Trial started· ClinicalTrials.gov
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
Primary completion· ClinicalTrials.gov
Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer
Trial registered· ClinicalTrials.gov
Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)
Trial registered· ClinicalTrials.gov
A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastat
Primary completion· ClinicalTrials.gov
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (
Primary completion· ClinicalTrials.gov
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
Trial registered· ClinicalTrials.gov
A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With R
Primary completion· ClinicalTrials.gov
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
Primary completion· ClinicalTrials.gov
Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
Primary completion· ClinicalTrials.gov
The Sagittarius Trial
Trial started· ClinicalTrials.gov
5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
Primary completion· ClinicalTrials.gov
A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (
Primary completion· ClinicalTrials.gov
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Muta
Primary completion· ClinicalTrials.gov
Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors
Trial started· ClinicalTrials.gov
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Trial started· ClinicalTrials.gov
Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
Primary completion· ClinicalTrials.gov
Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expressi
Trial started· ClinicalTrials.gov
Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
Trial started· ClinicalTrials.gov
Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
Trial registered· ClinicalTrials.gov
IFN-Gamma Expression as a Predictor of Response to Immune Checkpoint Inhibitors in First-Line Metastatic Melanoma
Results posted· ClinicalTrials.gov
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute M
Primary completion· ClinicalTrials.gov
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ab
Primary completion· ClinicalTrials.gov
A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer
Primary completion· ClinicalTrials.gov
Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies
FDA approval (supplemental)· FDA
Sponsor: ARGENX BV. Class: Labeling.
Trial started· ClinicalTrials.gov
Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO-RT Trial
Trial registered· ClinicalTrials.gov
Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Trial registered· ClinicalTrials.gov
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
Primary completion· ClinicalTrials.gov
Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Trial registered· ClinicalTrials.gov
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advance
Primary completion· ClinicalTrials.gov
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
Primary completion· ClinicalTrials.gov
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
Results posted· ClinicalTrials.gov
Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
Trial registered· ClinicalTrials.gov
Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
Results posted· ClinicalTrials.gov
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating
Results posted· ClinicalTrials.gov
ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Su
FDA approval· FDA
Sponsor: JANSSEN BIOTECH. Class: Type 5 - New Formulation or New Manufacturer.
Results posted· ClinicalTrials.gov
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer
Results posted· ClinicalTrials.gov
METIMMOX: Colorectal Cancer METastasis - Shaping Anti-tumor IMMunity by OXaliplatin
Results posted· ClinicalTrials.gov
Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarci
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Labeling.
Trial registered· ClinicalTrials.gov
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Trial registered· ClinicalTrials.gov
A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)
Trial registered· ClinicalTrials.gov
5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors
Trial registered· ClinicalTrials.gov
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
Trial registered· ClinicalTrials.gov
Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC
Trial started· ClinicalTrials.gov
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)
Trial registered· ClinicalTrials.gov
Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
Trial registered· ClinicalTrials.gov
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
Trial started· ClinicalTrials.gov
Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC
Trial started· ClinicalTrials.gov
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination With Nivolumab in Participants With Relapsed/Refractory
Trial started· ClinicalTrials.gov
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gast
Trial registered· ClinicalTrials.gov
Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
Trial started· ClinicalTrials.gov
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Primary completion· ClinicalTrials.gov
Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma
Primary completion· ClinicalTrials.gov
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients Wi
Trial started· ClinicalTrials.gov
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer
Primary completion· ClinicalTrials.gov
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Trial started· ClinicalTrials.gov
Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Primary completion· ClinicalTrials.gov
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA
Primary completion· ClinicalTrials.gov
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastat
Primary completion· ClinicalTrials.gov
Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer
Primary completion· ClinicalTrials.gov
Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell
Primary completion· ClinicalTrials.gov
Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
Results posted· ClinicalTrials.gov
A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma
Primary completion· ClinicalTrials.gov
Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
Results posted· ClinicalTrials.gov
An Open-Label Phase II Study of Nivolumab or Nivolumab/Ipilimumab in Adult Participants With Progessive/ Recurrent Meningioma
Primary completion· ClinicalTrials.gov
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Ni
Primary completion· ClinicalTrials.gov
Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy
Results posted· ClinicalTrials.gov
Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
Trial registered· ClinicalTrials.gov
First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Can
Results posted· ClinicalTrials.gov
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Primary completion· ClinicalTrials.gov
Real-World Outcomes of First-Line Nivolumab + Ipilimumab With Chemotherapy in Non-Small Cell Lung Cancer in Poland
Primary completion· ClinicalTrials.gov
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.