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Immuno-oncology checkpoint inhibitors · Live ClinicalTrials.gov data

Nivolumab (Opdivo) clinical trial pipeline

The timeline below tracks the 16 largest phase 2–4 nivolumab (Opdivo) trials on ClinicalTrials.gov by enrolment, 4 of them actively recruiting. The next phase 3 primary completion among them is expected Mar 2027. Refreshed daily. Add up to four competitors to compare pipelines side by side.

16+

Major trials tracked

3

Phase 3 trials

4

Actively recruiting

Mar 2027

Next phase 3 primary completion

4,031

Participants across trials

National Cancer Institute (NCI)

Lead sponsor by trial count

nivolumab (16)9 active2015–2030
nivolumab
Key
Actual date
Anticipated
Forecast to primary completion
RecruitingActive, not recruitingCompletedUnknown status
'15
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'19
'21
'23
'25
'27
'29
nivolumab
Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancerP2
Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)P2
INITIATEP2
Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)P3
ATHENAP3
A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint InhibitorsP2
Nivolumab With Chemotherapy in Pleural Mesothelioma After SurgeryP2
Adjuvant Treatment Determined By Pathological Response To Neoadjvuant NivolumabP2
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer PatientsP3
NIVOPTIMIZEP4
PICASSOP2
ctDNA Lung RCTP2
DIALP2
Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder CancerP2
reICBP2
CANIQOLP4

Upcoming readouts

3 ahead · nivolumab

Select a trial to load its full ClinicalTrials.gov record.

Key nivolumab trials

Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Trial names open the full ComplyRx trial page; NCT ids link to ClinicalTrials.gov.

TrialTitlePhaseStatusPrimary completion
NCT07028125CANIQOL: Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivoluma…Phase 4RecruitingOct 2028
NCT06116461NIVOPTIMIZE: Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable ResponsePhase 4UnknownOct 2024
NCT03522246ATHENA: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment F…Phase 3Active, not recruitingMay 2024
NCT04444921EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Ca…Phase 3Active, not recruitingMar 2027
NCT03117049Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)Phase 3CompletedFeb 2020
NCT05255302DIAL: De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Di…Phase 2RecruitingMay 2025
NCT07130032reICB: Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic…Phase 2RecruitingAug 2025
NCT04966663ctDNA Lung RCT: Using ctDNA to Determine Therapies for Lung CancerPhase 2RecruitingAug 2026
NCT04013854Adjuvant Treatment Determined By Pathological Response To Neoadjvuant NivolumabPhase 2Active, not recruitingAug 2026
NCT03693014A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inh…Phase 2Active, not recruitingOct 2027
NCT03048474INITIATE: Ipilimumab and Nivolumab in the Treatment of Malignant Pleural MesotheliomaPhase 2CompletedDec 2017
NCT02498600Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelia…Phase 2CompletedSept 2018

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FAQ

How many clinical trials are running for nivolumab?
ClinicalTrials.gov lists more than 16 phase 2–4 nivolumab trials. This page tracks the 16 largest by enrolment: 11 phase 2, 3 phase 3, and 2 phase 4 among them, with 4 actively recruiting. Updated daily.
Are there clinical trials for Opdivo?
Opdivo is the brand name for nivolumab, so nivolumab trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 nivolumab trials. This page tracks the 16 largest by enrolment: 11 phase 2, 3 phase 3, and 2 phase 4 among them, with 4 actively recruiting. Updated daily.
Where does this data come from?
All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
Can I compare nivolumab against other drugs?
Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.
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