Nivolumab: clinical trials recruiting now
76
Recruiting trials
15
Conditions studied
50
US states with sites
44
Countries
FDA drug label
- FDA-approved
- Yes. Nivolumab appears in the FDA drug-label database. Marketed as OPDIVO.
- Drug class
- Programmed Death Receptor-1 Blocking Antibody (FDA established pharmacologic class)
- Mechanism of action
- Programmed Death Receptor-1-directed Antibody Interactions (as stated on the FDA label)
FDA-approved use
OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1) • for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. (1.4) • adult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. (1.5) • adult patients with metastatic o…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility. — Bristol-Myers Squibb Company | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-10-21 |
Phase breakdown
Early Phase 1 2
Phase 1 25
Phase 2 50
Phase 3 10
Not applicable 5
Conditions being studied
Recruiting trials involving Nivolumab
- A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
- A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
- A Study of TRK-950 in Patients With Advanced Solid Tumors
- A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
- A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
- ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
- Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery
- Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
- Agnostic Therapy in Rare Solid Tumors
- Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)
- BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma
- Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
- Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases
- BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
- Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets
- BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
- Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma
- Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
- Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
- Cryoablation+Ipilimumab+Nivolumab in Melanoma
- DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC
- Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
- Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
- ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
- Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
- FOG-001 in Locally Advanced or Metastatic Solid Tumors
- First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
- IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
- IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
- Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients
- Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
- Immunotherapy Efficacy and PD-L1 as a Predictive Biomarker in Metastatic Melanoma in Slovenia
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
- Immunotherapy in Patients With Early dMMR Rectal Cancer
- Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma
- Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
- MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
- MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.
- MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors
- Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
- NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
- Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
- Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
- Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
- Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
- PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
- Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
- Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer
- Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)
- Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
- Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
- Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
- Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
- Repositioning Immunotherapy in VetArans With Lung Cancer
- SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
- SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
- Saci Nivo Rela for TNBC
- Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
- Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
- Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
- Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
- Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
- Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
- Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
- Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
- Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated
- Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
- Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
- Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
- Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
- Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD
- Using ctDNA to Determine Therapies for Lung Cancer
- VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
- ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab
Common questions
Is Nivolumab FDA-approved?
Yes, marketed as OPDIVO.
How many recruiting trials involve Nivolumab?
76 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.