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

OPDIVO Clinical Trials Update, Market Analysis, and Projections

Last updated: February 21, 2026

What is the current status of OPDIVO's clinical trials?

OPDIVO (nivolumab), a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb, is actively tested across multiple cancer indications. As of March 2023, the company reports 35 ongoing or upcoming trials encompassing 20 tumor types, including lung, melanoma, renal cell carcinoma, and bladder cancers. Of these, 10 are Phase 3 studies, with notable results in non-small cell lung cancer (NSCLC) and melanoma.

Major completed trials include CheckMate 227 (lung cancer), CheckMate 037 (melanoma), and CheckMate 214 (renal cell carcinoma). These trials have contributed to regulatory approvals in over 65 countries.

The pipeline emphasizes combination therapies, specifically pairing OPDIVO with chemotherapy, other immunotherapies, and targeted agents. The company is also testing OPDIVO in earlier lines of treatment and adjuvant settings, expanding its scope.

How does OPDIVO perform in key clinical trials?

Trial Name	Phase	Indication	Primary Endpoint	Outcome Summary	Regulatory Status
CheckMate 227	III	NSCLC	OS, PFS	Improved overall survival with combination therapies; p<0.05	Approved in US, EU, others
CheckMate 214	III	Renal Cell Carcinoma	OS, ORR	Superior OS and ORR vs sunitinib; p<0.001	Approved in US, EU, China
CheckMate 037	II	Melanoma	ORR	ORR of 31%, durable responses	Marketed globally

Ongoing trials report promising data for early-stage and triple-negative breast cancers, often with higher response rates when combined with other agents.

What are the key regulatory milestones and approvals?

OPDIVO has achieved over 40 approvals worldwide, including:

• United States: Approved for unmatched indications such as melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and urothelial carcinoma.
• European Union: Approved for similar indications, with additional approvals for head and neck cancers.
• China: Multiple approvals, including lung cancer and melanoma, leveraging accelerated pathways.

Recent approvals in the adjuvant setting for melanoma and in combination with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) reflect the drug's expanding role.

What is the current market landscape?

Market Size

The global anticancer immunotherapy market reached $155 billion in 2022 and is projected to grow at 14% CAGR through 2030. OPDIVO held a 26% share in 2022, with sales totaling approximately $9.1 billion, making it the best-selling PD-1 inhibitor.

Competitive Position

OPDIVO's primary competitors include Pembrolizumab (Keytruda, Merck), cemiplimab (Libtayo, Regeneron), and atezolizumab (Tecentriq, Roche). Its broad label portfolio and combination trial success place it ahead in several indications, particularly NSCLC and melanoma.

Revenue Growth Trends

Year	Revenue (USD billion)	Year-over-Year Change
2020	8.2	-
2021	8.9	+8.5%
2022	9.1	+2.2%

Incremental growth in 2022 reflects market saturation in established indications but also expansion into new tumor types.

What are the projected trends for OPDIVO?

Sales Forecast

By 2030, OPDIVO is expected to reach annual sales of $18–20 billion. Growth drivers include:

• Approval in additional early-line settings.
• Expanded indications in gastrointestinal and head and neck cancers.
• Successful combination regimens increasing its utility.

Market Penetration Strategies

Bristol-Myers Squibb focuses on:

• Developing biomarker-driven therapies to refine patient selection.
• Enhancing global access through regulatory substitutions.
• Accelerating trial activity in emerging markets and novel indications.

Risk Factors

Market growth hinges on:

• Competitive pressure from biosimilars and newer immunotherapies.
• Regulatory delays in approving new indications.
• Safety concerns and management of immune-related adverse events.

What are the implications of recent clinical data?

The positive outcomes in trials like CheckMate 9LA (first-line NSCLC with chemotherapy and ipilimumab) highlight OPDIVO's role in shifting treatment paradigms. As its indication scope broadens, market share will increase.

Trial failures, such as the phase 3 misadventures with OPDIVO in colorectal cancer, demonstrate the importance of precise biomarker strategies and patient stratification.

Key Market Projections (2023–2030)

Aspect	Current Status	2025 Projection	2030 Projection
Revenue (USD)	~$9.1 billion	~$14 billion	~$18–20 billion
Market Share	26% in PD-1 segment	28–30%	30%+
Indications	15+ approvals	20+ approvals	25+ approvals

Key Takeaways

• OPDIVO continues expanding its clinical reach with high-profile Phase 3 trials delivering positive outcomes.
• It remains the leading PD-1 inhibitor, capturing a large share of the immunotherapy market.
• By 2030, global sales are expected to nearly double, driven by new approvals, combination regimens, and indication expansion.
• Competitive landscape remains fierce, with Merck’s pembrolizumab as the primary rival.
• Market growth depends on managing regulatory, safety, and competitive risks.

FAQs

1. What are the primary indications for OPDIVO?
OPDIVO is approved for melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, and small cell lung cancer, among others.

2. When did regulatory approvals for OPDIVO begin?
OPDIVO received its first approval for melanoma in Japan in 2014, followed by US approval in 2015. Subsequent approvals expanded its uses globally.

3. How does OPDIVO compare to pembrolizumab?
Both are PD-1 inhibitors targeting similar patient populations. OPDIVO often leads in combination trials and approvals in certain indications, but pembrolizumab has a broader label in some markets.

4. What are the main challenges facing OPDIVO’s market growth?
Market challenges include competition from biosimilars, emerging immunotherapies, safety concerns, and regulatory delays in new indications.

5. What are the key drivers of OPDIVO’s future revenue?
Expanded approvals, combination therapy success, incorporation into earlier lines of treatment, and emerging markets will be primary revenue drivers.

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References

1. Bristol-Myers Squibb. (2023). OPDIVO (nivolumab) clinical pipeline and regulatory updates.
2. IQVIA. (2023). Global Oncology Market Report 2022–2023.
3. European Medicines Agency. (2023). OPDIVO product information.
4. U.S. Food & Drug Administration. (2023). Approved oncology products.
5. MarketWatch. (2023). Immuno-oncology market size and forecasts.