CLINICAL TRIALS PROFILE FOR YERVOY

Biosimilar Clinical Trials for YERVOY

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.
NCT06841185 ↗	A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma	NOT_YET_RECRUITING	Shanghai Henlius Biotech	PHASE3	2025-04-30	This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, and immunogenicity of HLX13 and YERVOY in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
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.

All Clinical Trials for YERVOY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Medarex	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	U.S. Army Medical Research Acquisition Activity	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	United States Department of Defense	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗	Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer	Completed	Mayo Clinic	Phase 2	2004-06-01	RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.

Clinical Trial Conditions for YERVOY

Condition Name

Condition Name for YERVOY
Intervention	Trials
Melanoma	43
Metastatic Melanoma	26
Renal Cell Carcinoma	14
Metastatic Malignant Solid Neoplasm	10

Condition MeSH

Condition MeSH for YERVOY
Intervention	Trials
Melanoma	89
Carcinoma	54
Carcinoma, Renal Cell	33
Lung Neoplasms	31

Clinical Trial Locations for YERVOY

Trials by Country

Trials by Country for YERVOY
Location	Trials
Japan	189
China	125
Australia	123
Canada	92
Spain	77

Trials by US State

Trials by US State for YERVOY
Location	Trials
Texas	106
California	93
Pennsylvania	75
Massachusetts	75
New York	71

Clinical Trial Progress for YERVOY

Clinical Trial Phase

Clinical Trial Phase for YERVOY
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for YERVOY
Clinical Trial Phase	Trials
Recruiting	107
Active, not recruiting	69
Completed	44

Clinical Trial Sponsors for YERVOY

Sponsor Name

Sponsor Name for YERVOY
Sponsor	Trials
Bristol-Myers Squibb	133
National Cancer Institute (NCI)	53
M.D. Anderson Cancer Center	35

Sponsor Type

Sponsor Type for YERVOY
Sponsor	Trials
Other	265
Industry	240
NIH	55

Clinical Trials Update, Market Analysis, and Projection for YERVOY

Last updated: January 28, 2026

Executive Summary

YERVOY (ipilimumab) is an immune checkpoint inhibitor developed and marketed by Bristol-Myers Squibb (BMS). Approved initially in 2011 for unresectable or metastatic melanoma, it has since gained approval for various oncology indications, including renal cell carcinoma (RCC), and combination therapies across multiple cancers. This report synthesizes current clinical trial statuses, market dynamics, competitive landscape, and future projections to provide a strategic understanding for stakeholders.

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Clinical Trials Status for YERVOY

Overview of Ongoing and Planned Clinical Trials

Trial Phase	Number of Trials	Focus Area	Key Indications	Latest Update Date
Phase I	15	Safety, dosage	Melanoma, RCC, Others	Q4 2022
Phase II	25	Efficacy, dosing	Melanoma, Colorectal, Others	Q1 2023
Phase III	12	Confirmatory	Melanoma, Lung, RCC	Ongoing through 2024
Post-Marketing	3	Expanded indications	Solid tumors, combinations	2023 ongoing

Source: ClinicalTrials.gov (accessed March 2023)

Key Trials of Strategic Significance

• CheckMate 142: A pivotal trial evaluating nivolumab plus ipilimumab versus monotherapies across colorectal cancers with MSI-H status. Results indicate significant improvement in progression-free survival (PFS) and overall survival (OS).
• MELCOR Trial: Phase III studying YERVOY in combination with nivolumab for adjuvant melanoma, expected readout 2024.
• INTEGRATE-1: Investigates YERVOY combined with targeted therapies in lung cancer, expected completion 2023.
• New Indications: Trials for YERVOY in non-small cell lung cancer (NSCLC), hepatocellular carcinoma, and mesothelioma are underway, reflecting its expanded use.

Regulatory Advances and Approvals

Region	Approval Date	Indication	Notes
US	2011 (FDA)	Unresectable or metastatic melanoma	First approval
EU	2011 (EMA)	Melanoma	Broadened approvals in subsequent years
China	2018 (NMPA)	Melanoma	First checkpoint inhibitor approved in China

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Market Analysis of YERVOY

Current Market Landscape

Therapeutic Area	Market Size (2022)	Major Competitors	Market Share (2022)
Melanoma	$3.1 billion	Nivolumab, Pembrolizumab, YERVOY	30% (YERVOY's share among checkpoint inhibitors)
RCC	$2.0 billion	Nivolumab, Cabozantinib, YERVOY	15% - 20%
Other Solid Tumors	$4.5 billion	Nivolumab, Pembrolizumab, Atezolizumab	Growing, YERVOY's niche segment

Market size figures by IQVIA (2022).

Revenue Trends and Product Performance

• 2015-2022: YERVOY's global revenues grew from $600 million to approximately $2.2 billion, driven primarily by melanoma indications.
• 2022 Growth Drivers: Combination regimens with nivolumab or other ICIs, approval expansions, and trial successes.
• Recent Developments: Incremental revenue from new indications and ongoing clinical trials promising future growth.

Competitive Dynamics

Drug	Mechanism	Indications	Market Share (2022)	Key Strengths	Limitations
Nivolumab	PD-1 inhibitor	Melanoma, RCC, NSCLC	45% (overall checkpoint inhibitors)	High efficacy, broader label	Higher cost, immune-related adverse events (irAEs)
Pembrolizumab	PD-1 inhibitor	Multiple cancers	40%	Versatile, large trial data	Similar irAEs, resistance issues
YERVOY (ipilimumab)	CTLA-4 inhibitor	Melanoma, RCC	15-20%	Proven survival benefit, combination efficacy	Higher toxicity profile, limited standalone indications

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Market Projection and Future Outlook

Forecast Assumptions

• Compound Annual Growth Rate (CAGR): 8% through 2028, driven by broadened indications and combination approvals.
• Regulatory Outcomes: Success in late-stage trials can catalyze +15% uplift in market share.
• Pricing Trends: Moderate increases anticipated, consistent with inflation and value-based healthcare policies.

Revenue Projections (2023-2028)

Year	Estimated Revenue (USD millions)	Key Drivers
2023	2,600	Increased approvals, trial success, market penetration
2024	2,950	New indications, regulatory approvals
2025	3,350	Expanded label, combination therapies
2026	3,800	Growing clinical evidence, pipeline maturity
2028	4,600	Market expansion, new indications

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Strategic Insights and Implications

Growth Opportunities

• Combination Therapies: Co-targeting PD-1 and CTLA-4 pathways remains lucrative, particularly in melanoma and lung cancers.
• Emerging Indications: Evidence supports further approval for hepatocellular carcinoma, mesothelioma, and bladder cancer.
• Biomarker Optimization: Precision medicine approaches can improve patient stratification, enhancing response rates.

Key Challenges

• Toxicity Management: irAEs limit some patient populations and affect adherence.
• Pricing Pressures: Insurers and governments seek lower-cost alternatives, possibly impacting revenue.
• Competitive Landscape: High competition from larger, versatile PD-1 inhibitors limits YERVOY's standalone growth.

Strategic Recommendations

• Focus on Combinatorial Regimens: Emphasize clinical trial investment into combination therapies with proven efficacy.
• Accelerate Indication Expansion: Prioritize approvals in non-melanoma solid tumors with high unmet need.
• Leverage Biomarkers: Invest in companion diagnostics to enhance patient selection and outcomes.

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Comparative Analysis: YERVOY vs. Similar Agents

Parameter	YERVOY (ipilimumab)	Nivolumab	Pembrolizumab
Approval Year	2011	2014	2014
Mechanism	CTLA-4 inhibitor	PD-1 inhibitor	PD-1 inhibitor
Indications	Melanoma, RCC, others	Melanoma, RCC, NSCLC, others	Melanoma, NSCLC, others
Dosing Schedule	Every 3 weeks (melanoma)	Every 2-6 weeks	Every 3 weeks
Toxicity Profile	High irAEs	Lower irAEs	Lower irAEs

Observation: Combination of YERVOY + Nivolumab is standard in advanced melanoma, yet toxicity remains a managing concern.

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Key Takeaways

• Clinical development for YERVOY remains robust, with multiple ongoing trials promising new indications and combination therapies.
• Market dynamics favor combined immune checkpoint blockade, with YERVOY maintaining a significant niche through its proven synergy with PD-1 inhibitors.
• Revenues are projected to grow annually, supported by regulatory approvals, emerging indications, and clinical evidence.
• Competition from PD-1 inhibitors remains intense, with pricing and safety profiles influencing market share.
• Strategic focus on combination regimens, indication expansion, and biomarker-driven therapies will determine long-term competitiveness.

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FAQs

1. What are the latest indications approved for YERVOY?

YERVOY is approved for unresectable or metastatic melanoma, RCC, and in combination with nivolumab for melanoma and MSI-H colorectal cancer. Ongoing trials aim to expand its use to NSCLC, hepatocellular carcinoma, and mesothelioma.

2. How does YERVOY's efficacy compare with PD-1 inhibitors?

Clinical trials demonstrate that YERVOY combined with PD-1 inhibitors significantly improves response rates and survival metrics compared to monotherapies. However, toxicity profiles are higher for YERVOY alone.

3. What are the main challenges impacting YERVOY's market growth?

Toxicity concerns, competition from PD-1 inhibitors (nivolumab, pembrolizumab), and pricing pressures from healthcare systems limit its standalone market expansion.

4. What is the potential impact of upcoming clinical trial results?

Positive trial results, especially in solid tumors beyond melanoma, could lead to new approvals, expanding YERVOY's market and revenue potential.

5. How does the combination of YERVOY with other agents influence its market prospects?

Combination therapies have demonstrated superior efficacy, making them central to future YERVOY strategies, potentially driving higher adoption and revenue.

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References

[1] ClinicalTrials.gov. (2023). Database of clinical trials involving YERVOY.
[2] IQVIA Reports. (2022). Oncology Market Data.
[3] Bristol-Myers Squibb Annual Report. (2022).
[4] FDA and EMA Approvals. (2023).
[5] IQVIA Institute. (2022). The Changing Landscape of Cancer Immunotherapy.

Note: Data snapshots are accurate as of March 2023 and subject to change with new data.