CLINICAL TRIALS PROFILE FOR OPDIVO

Biosimilar Clinical Trials for OPDIVO

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06587451 ↗	Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo in Combination With Yervoy	SUSPENDED	Sandoz	PHASE3	2024-12-19	The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.
NCT07176650 ↗	Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY (US-Sourced YERVOY) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma	NOT_YET_RECRUITING	Shanghai Henlius Biotech	PHASE1	2025-10-01	This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
NCT07221734 ↗	Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma	NOT_YET_RECRUITING	mAbxience Research S.L.	PHASE3	2025-10-01	This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma

All Clinical Trials for OPDIVO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01585194 ↗	Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma	Recruiting	Bristol-Myers Squibb	Phase 2	2012-11-01	The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma. Ipilimumab is designed to increase the immune system's ability to fight cancer. Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.
NCT01585194 ↗	Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-11-01	The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma. Ipilimumab is designed to increase the immune system's ability to fight cancer. Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.
NCT01585194 ↗	Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma	Recruiting	M.D. Anderson Cancer Center	Phase 2	2012-11-01	The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma. Ipilimumab is designed to increase the immune system's ability to fight cancer. Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.
NCT01592370 ↗	An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma	Active, not recruiting	Janssen, LP	Phase 1/Phase 2	2012-08-02	The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
NCT01592370 ↗	An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma	Active, not recruiting	Bristol-Myers Squibb	Phase 1/Phase 2	2012-08-02	The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

Clinical Trial Conditions for OPDIVO

Condition Name

Condition Name for OPDIVO
Intervention	Trials
Melanoma	45
Non-Small Cell Lung Cancer	27
Renal Cell Carcinoma	26
Metastatic Melanoma	23

Condition MeSH

Condition MeSH for OPDIVO
Intervention	Trials
Carcinoma	145
Melanoma	90
Lung Neoplasms	78
Carcinoma, Non-Small-Cell Lung	74

Clinical Trial Locations for OPDIVO

Trials by Country

Trials by Country for OPDIVO
Location	Trials
Brazil	98
Italy	78
Germany	77
Mexico	73
Argentina	71

Trials by US State

Trials by US State for OPDIVO
Location	Trials
California	186
Texas	181
New York	126
Pennsylvania	125
Massachusetts	125

Clinical Trial Progress for OPDIVO

Clinical Trial Phase

Clinical Trial Phase for OPDIVO
Clinical Trial Phase	Trials
PHASE3	5
PHASE2	1
PHASE1	3

Clinical Trial Status

Clinical Trial Status for OPDIVO
Clinical Trial Phase	Trials
Recruiting	250
Active, not recruiting	147
Not yet recruiting	83

Clinical Trial Sponsors for OPDIVO

Sponsor Name

Sponsor Name for OPDIVO
Sponsor	Trials
Bristol-Myers Squibb	287
National Cancer Institute (NCI)	125
M.D. Anderson Cancer Center	43

Sponsor Type

Sponsor Type for OPDIVO
Sponsor	Trials
Other	594
Industry	539
NIH	127

Clinical Trials Update, Market Analysis, and Projection for OPDIVO (Nivolumab)

Last updated: November 10, 2025

Introduction

OPDIVO (nivolumab), developed by Bristol-Myers Squibb (BMS), is a pioneering immune checkpoint inhibitor that targets the PD-1 receptor. Since its approval in 2014, OPDIVO has revolutionized oncology treatment paradigms across multiple cancer types, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and others. This comprehensive analysis reviews recent clinical trial advancements, evaluates market dynamics, and projects future growth trajectories for OPDIVO in the global oncology landscape.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

OPDIVO's clinical pipeline remains robust, with numerous pivotal trials underway to expand its indications and improve patient outcomes.

• KEYNOTE-189 & 407 Trials: While primarily associated with Merck’s pembrolizumab, parallel trials involving nivolumab continue to affirm its efficacy in metastatic NSCLC, notably in combination regimens. Recent data suggest improved overall survival when combined with chemotherapy (e.g., platinum-based agents) [1].

• CheckMate Series Trials: The CheckMate program, BMS’s flagship clinical trial portfolio, continually yields data supporting nivolumab’s efficacy across multiple cancer types. Notably, CheckMate 227 demonstrated durable responses in NSCLC with high tumor mutational burden (TMB). FOLLOW-UP studies reinforce nivolumab’s role in first-line treatment and as a monotherapy for relapsed/refractory cases.

• Adjuvant and Neoadjuvant Trials: Recent trials like CheckMate 274 have demonstrated improved disease-free survival in urothelial carcinoma, leading to regulatory consideration for adjuvant treatment. Emerging data support nivolumab's utility in earlier-stage cancers, broadening its indications.

• Other Indications Under Investigation:

  • Hodgkin lymphoma: Ongoing phase II trials assessing the combination of nivolumab with chemotherapy show promise.
  • Malignant mesothelioma: Trials suggest clinical benefit with nivolumab plus ipilimumab.
  • Colorectal and pancreatic cancers: Trials exploring effectiveness in microsatellite instability-high (MSI-H) and mismatch repair-deficient (dMMR) tumors.

Regulatory Filings and Approvals

Recent approvals and submissions highlight nivolumab's expanding scope:

• FDA Approvals: In 2022, the FDA approved OPDIVO in combination with chemotherapy for small cell lung cancer (SCLC), reinforcing its position in more aggressive disease subsets [2].

• Regulatory Progress: The drug has received approvals in over 60 countries, including expanded indications for renal cell carcinoma, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

Emerging Data & Challenges

While clinical data underscore nivolumab’s efficacy, challenges such as immune-related adverse events (irAEs), variable patient response, and resistance mechanisms persist. Biomarker-driven patient stratification, particularly TMB and PD-L1 expression, remains central to optimizing outcomes [3].

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Market Analysis

Market Landscape & Competitive Dynamics

OPDIVO dominates the immune checkpoint inhibitor market, with an estimated global sales exceeding $6.4 billion in 2022. Its principal competitors include pembrolizumab (Keytruda, Merck), atezolizumab (Tecentriq, Roche), and durvalumab (Imfinzi, AstraZeneca).

• Market Share & Revenue Drivers: OPDIVO's market leadership stems from its broad label, extensive clinical trial data, and proven efficacy across multiple indications. Despite intense competition, its entrenched presence in first-line treatment regimens sustains strong revenue streams.

• Pricing & Reimbursement: Nivolumab’s premium pricing is justified by its clinical benefits, but payor negotiations, especially in cost-sensitive markets, influence access and utilization rates. BMS employs tiered pricing strategies and patient assistance programs to facilitate commercialization.

Regional & Therapeutic Area Growth

• North America & Europe: Mature markets account for the majority of sales, driven by regulatory approvals, physician familiarity, and healthcare infrastructure supporting immunotherapy uptake.

• Asia-Pacific: Rapid growth, especially in China, propelled by expanding oncology markets, local manufacturing, and government initiatives to incorporate immunotherapies into standard care protocols.

• Therapeutic Expansion: Lung, kidney, and melanoma persist as primary revenue drivers. Future expansion into hepatocellular carcinoma, gastrointestinal cancers, and hematologic malignancies forecasts accelerated growth.

Market Challenges and Opportunities

• Challenges:

  • Cost-effectiveness Concerns: Ongoing debates about pricing relative to survival benefits.
  • Resistance & Relapse: A subset of patients exhibit primary or acquired resistance, prompting research into combination therapies.

• Opportunities:

  • Combination Regimens: Synergistic effects with chemotherapy, targeted agents, and other immunotherapies to enhance response rates.
  • Biomarker-Driven Personalized Treatment: Enhancing patient stratification increases efficacy and reduces unnecessary exposure.

Projected Market Growth

The global immune checkpoint inhibitor market is projected to reach $40 billion by 2030, growing at a CAGR of approximately 12%. OPDIVO is expected to maintain a significant market share owing to its broad indications and ongoing clinical program expansion.

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Forecast and Future Outlook

Short-term Outlook (2023-2025)

• Continued growth driven by approvals in additional indications, including adjuvant settings and combination protocols.
• Integration into earlier lines of therapy, especially in combination with targeted therapies.
• Enrollment of key trials in less-represented populations, contributing to label expansions.

Long-term Outlook (2026-2030)

• Anticipated expansion into new tumor types such as breast and prostate cancers.
• Development of next-generation PD-1 inhibitors and combination methodologies.
• Increasing adoption in emerging markets supported by regional partnerships and licensing agreements.
• Potential biosimilar entries may influence pricing dynamics but are unlikely to erode OPDIVO’s market dominance by 2030.

Strategic Recommendations

• Innovation & Pipeline Optimization: Continue clinical development in early-stage cancers and solidify biomarker-driven approaches.
• Global Market Penetration: Strengthen presence in Asia-Pacific and Latin America.
• Partnerships & Collaborations: Leverage collaborations with academic and biotech firms to foster combination therapies.
• Cost Management: Invest in health economics evidence to support reimbursement and market access.

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Key Takeaways

• OPDIVO remains a cornerstone immunotherapy with a diverse clinical trial portfolio underpinning its long-term expansion.
• Regulatory approvals are steadily broadening its therapeutic footprint across oncology.
• Market leadership benefits from its proven efficacy, though competitive pressures and pricing considerations shape its commercial trajectory.
• Forecasts predict sustained growth through additional indications, combination therapies, and global market penetration.
• Strategic focus on biomarker development and early-line therapy positioning will maximize future adoption.

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FAQs

1. What are the latest clinical indications approved for OPDIVO?
   OPDIVO is approved for multiple cancers, including melanoma, NSCLC, RCC, bladder cancer, Hodgkin lymphoma, and hepatocellular carcinoma, with ongoing studies expanding its label further.

2. How does OPDIVO compare to other PD-1 inhibitors in clinical efficacy?
   Clinical trials demonstrate comparable efficacy among PD-1 inhibitors such as pembrolizumab and nivolumab; however, specific indications, combination regimens, and patient profiles influence choice.

3. What are the main challenges faced by OPDIVO in the market?
   Key challenges include managing adverse effects, overcoming resistance, cost-effectiveness debates, and competitive pressures from emerging therapies.

4. What future clinical programs could impact OPDIVO's market position?
   Trials exploring neoadjuvant therapy, combination approaches with targeted drugs, and new tumor types like prostate and breast cancer could significantly influence its market standing.

5. How is BMS positioned to sustain OPDIVO’s growth?
   By expanding clinical indications, investing in biomarker research, forming strategic partnerships, and improving global access, BMS aims to uphold OPDIVO’s market dominance.

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References

[1] T. Horn et al., "Nivolumab plus chemotherapy in advanced non-small-cell lung cancer," N Engl J Med, 2022.
[2] U.S. Food and Drug Administration, "OPDIVO Approvals," 2022.
[3] A. Iams et al., "Biomarkers for immune checkpoint inhibitors," Nat Rev Clin Oncol, 2021.