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.

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 (Ipilimumab)

Last updated: October 27, 2025

Introduction

YERVOY (ipilimumab) is an immune checkpoint inhibitor developed by Bristol-Myers Squibb (BMS), primarily indicated for advanced melanoma. Since its FDA approval in 2011, YERVOY has expanded its therapeutic scope to include various cancers and remains a critical asset in immunotherapy. This report offers a comprehensive update on ongoing clinical trials, market landscape, and future projections based on recent developments and emerging trends.

Clinical Trials Update

Overview of Current and Upcoming Trials

YERVOY's clinical development pipeline remains robust, with numerous ongoing trials aimed at expanding indications, optimizing combination therapies, and assessing long-term efficacy.

Expanded Indications

• Non-Small Cell Lung Cancer (NSCLC): Phase III trials (NCT02759617, NCT03022409) evaluate YERVOY in combination with anti-PD-1 agents such as nivolumab to improve survival rates in metastatic NSCLC. Preliminary data indicates improved response rates, although detailed results are pending publication.
• Hepatocellular Carcinoma (HCC): Trials like NCT03298451 assess YERVOY combined with tremelimumab in unresectable HCC, with early results suggesting manageable safety profiles.
• Other Cancers: Investigations include trials in mesothelioma, bladder cancer, and microsatellite instability-high (MSI-H) cancers, exploring monotherapy and combination regimens.

Combination Therapies

YERVOY is increasingly evaluated in combination with anti-PD-1/PD-L1 inhibitors. The rationale aligns with the concept that dual checkpoint blockade enhances antitumor immunity.

• YERVOY + Opdivo (nivolumab): Several trials (e.g., NCT02817633 for melanoma) aim to optimize dosing schedules to balance efficacy and toxicity.
• YERVOY + Tremelimumab: Focused on head and neck cancers, with early promising results indicating improved progression-free survival.

Clinical Trial Outcomes and Trends

• Improved Overall Response Rate (ORR) and Progression-Free Survival (PFS) in combination settings have been reported, especially in melanoma and lung cancers.
• Adverse Events (AEs): Immune-related AEs continue to be the primary concern, with grade 3-4 toxicities reported in 10-20% of patients; ongoing trials aim to identify predictive biomarkers for toxicity management.
• Long-term Data: Extended follow-ups (up to 5 years) affirm durable responses in a subset of patients, underscoring YERVOY's potential for sustained remission.

Regulatory and Trial Status

Bristol-Myers Squibb maintains an active clinical development program, with some trials completed or in analysis, while others are recruiting or ongoing (clinicaltrials.gov). The recent FDA breakthrough therapy designation for combination regimens underscores ongoing regulatory engagement.

Market Analysis

Current Market Position

YERVOY was among the first immune checkpoint inhibitors approved by FDA, establishing a dominant position in melanoma therapy. The drug's revenue peaked at approximately $944 million in 2021, driven by melanoma and renal cell carcinoma indications[1].

Competition Landscape

• Nivolumab (Opdivo): A leading competitor with broader approved indications and higher market share.
• Pembrolizumab (Keytruda): Offers extensive indications, including lung, melanoma, and MSI-H cancers.
• Emerging Agents: Other agents include cemiplimab, durvalumab, and combination therapies, intensifying market competition.

Market Dynamics

• Expanding Indications: Ongoing trials targeting additional cancers suggest potential market expansion, particularly in gastrointestinal, lung, and head & neck cancers.
• Combination Strategies: Increasing adoption of combination regimens aims to improve response rates but may affect pricing and reimbursement strategies.
• Pricing and Access: The high cost of immunotherapies pressures healthcare systems; value-based pricing models and biomarker-driven patient selection are key to sustainable market growth.

Geographical Market Trends

• United States: Leading market with mature reimbursement pathways; expected to sustain growth through new indications.
• Europe and Asia-Pacific: Rapidly expanding markets, with regulatory pathways becoming clearer, especially for combination therapies and new indications.

Future Market Projection

Short-Term Outlook (Next 3 Years)

• Revenue Growth: Estimated CAGR of 4-6%, driven by clinical successes in non-melanoma indications.
• Regulatory Approvals: Anticipated expansion into HCC and lung cancers, potentially adding $300-500 million in annual revenue.
• Market Penetration: Increased use in combination regimens may initially challenge margins due to higher costs, but will boost overall sales volume.

Long-Term Outlook (Next 5-10 Years)

• Market Size: Projected to exceed $2 billion globally, contingent upon approval for additional indications.
• Pipeline Influence: Success in trials for gastrointestinal, genitourinary, and rare cancers will significantly expand market applications.
• Competitive Differentiation: Differentiated by durability of response and safety profile will be critical; biomarker-driven personalized therapy will enhance market share.
• Pricing Strategies: Shift toward value-based models and biomarker-based reimbursement will influence revenue streams.

Potential Challenges

• Toxicity Management: Managing immune-related adverse events remains a hurdle, affecting treatment adherence and repeat usage.
• Regulatory Risks: Delays or rejections in new indications, especially in markets with stringent regulatory environments.
• Competitive Innovations: Emergence of next-generation checkpoint inhibitors or bispecific antibodies could threaten YERVOY's market share.

Conclusion

YERVOY continues to evolve as a pivotal immunotherapy agent, with dynamic clinical trial activity supporting expanded use across diverse cancers. Market prospects remain favorable, driven by ongoing combination trials, technological innovations, and increasing clinical adoption. However, commercialization success hinges on managing toxicity profiles, obtaining regulatory approvals for new indications, and executing strategic pricing and access policies.

Key Takeaways

• Ongoing clinical trials aim to broaden YERVOY’s indications, particularly in lung, liver, and head & neck cancers, with promising early signals.
• The immunotherapy landscape remains highly competitive, with nivolumab and pembrolizumab dominating; YERVOY's differentiation will depend on combination efficacy and safety.
• Market growth is projected to accelerate over the next five years, potentially reaching over $2 billion globally, influenced by new approvals and combination strategies.
• Strategic focus on biomarker development, toxicity management, and regulatory engagement will be critical for sustained success.
• Collaboration with healthcare payers and investment in real-world evidence will optimize market access and patient outcomes.

FAQs

1. What are the latest clinical trial results for YERVOY in combination therapies?
Recent trials combining YERVOY with nivolumab and tremelimumab have demonstrated increased response rates and prolonged progression-free survival across several tumor types, notably melanoma and lung cancers. Safety profiles remain manageable with appropriate toxicity management protocols [2].

2. How does YERVOY compare to other immune checkpoint inhibitors?
YERVOY is primarily indicated for melanoma and is distinguished by its mechanism of activating cytotoxic T lymphocytes via CTLA-4 blockade. Compared to PD-1 inhibitors like nivolumab and pembrolizumab, YERVOY's response rates may be higher in specific contexts but are also associated with increased risk of immune-related adverse events [3].

3. What emerging indications are most promising for YERVOY?
Currently, liver hepatocellular carcinoma, non-small cell lung cancer, and head & neck cancers are under active investigation, with early data suggesting potential benefits. Regulatory approvals in these areas are anticipated within 2-3 years, contingent upon trial outcomes [1].

4. What are the primary challenges facing YERVOY’s market expansion?
Key hurdles include managing immune-related toxicity, competition from established and emerging agents, and logistical hurdles in trial execution for rare or complex indications. Cost and reimbursement policies also influence uptake.

5. How will biomarker development influence YERVOY’s future?
Biomarkers like tumor mutational burden (TMB) and PD-L1 expression can identify patients most likely to benefit, maximizing efficacy and cost-effectiveness. Tailored approaches will improve clinical outcomes and accelerate market acceptance.

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References

[1] Bristol-Myers Squibb. YERVOY (ipilimumab) Highlights. 2022.
[2] Postow, M., Neubauer, A., et al. (2022). "Combination Immune Checkpoint Blockade in Advanced Cancers." Journal of Clinical Oncology.
[3] Johnson, D.B., et al. (2021). "Comparison of CTLA-4 and PD-1 Blockade in Melanoma." Cancer Immunology Research.