CLINICAL TRIALS PROFILE FOR IPILIMUMAB

All Clinical Trials for ipilimumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00162123 ↗	A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies	Completed	Bristol-Myers Squibb	Phase 2	2006-05-01	The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.
NCT00113984 ↗	Vaccine and Antibody Treatment of Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2005-06-08	This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA)-a protein that is normally produced by the patient's tumor cells. Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread beyond the original site may be eligible for this 7-month study. Candidates must have disease that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their tumor must produce PSA, and they must have no history of allergy to eggs or egg products Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically indicated, a cardiologic evaluation. Participants receive the priming vaccination on study day 1. After 2 weeks and then again every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected under the skin. On the day of each vaccination and daily for the next 3 days, patients receive an injection of GM-CSF to increase the number of immune cells at the vaccination site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as an infusion through a vein over 90 minutes. Patients are monitored for safety and treatment response with the following tests and procedures: - Blood and urine tests monthly, or more often if needed, to monitor liver, kidney, and other organ function. - Imaging studies to assess the tumor before starting treatment, again around study days 99 and 183, and then every 3 months after that while on study. - Apheresis (a procedure for collecting immune cells called lymphocytes) to measure the immune response to treatment. Apheresis is done three times: before starting the study and again around study days 99 and 183. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. This will only be done in participants who have the tissue marker HLA-A2 (about 50% of patients). Patients whose disease responds to treatment and who do not develop severe side effects may continue treatment beyond the initial 7-month study period on vaccine alone (without the antibody). After treatment is completed, patients are monitored for up to 15 years. This includes a medical history and physical examination for 5 years following the last vaccination. Information beyond 5 years is collected once a year by telephone.
NCT00094653 ↗	MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma	Completed	Bristol-Myers Squibb	Phase 3	2004-09-01	The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.
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.
NCT00060372 ↗	Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2003-04-01	This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Clinical Trial Conditions for ipilimumab

Condition Name

Condition Name for ipilimumab
Intervention	Trials
Melanoma	112
Metastatic Melanoma	50
Renal Cell Carcinoma	25
Non-Small Cell Lung Cancer	22

Condition MeSH

Condition MeSH for ipilimumab
Intervention	Trials
Melanoma	226
Carcinoma	97
Lung Neoplasms	64
Carcinoma, Non-Small-Cell Lung	63

Clinical Trial Locations for ipilimumab

Trials by Country

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Trials by Country for ipilimumab
Location	Trials
Japan	318
Australia	204
Argentina	81
Mexico	74
Chile	64

Trials by US State

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−

Trials by US State for ipilimumab
Location	Trials
California	164
Texas	158
New York	144
Pennsylvania	124
Florida	116

Clinical Trial Progress for ipilimumab

Clinical Trial Phase

Clinical Trial Phase for ipilimumab
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	47
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for ipilimumab
Clinical Trial Phase	Trials
Recruiting	228
Active, not recruiting	134
Completed	118

Clinical Trial Sponsors for ipilimumab

Sponsor Name

Sponsor Name for ipilimumab
Sponsor	Trials
Bristol-Myers Squibb	259
National Cancer Institute (NCI)	71
M.D. Anderson Cancer Center	40

Sponsor Type

Sponsor Type for ipilimumab
Sponsor	Trials
Other	633
Industry	503
NIH	75

Ipilimumab: Clinical Trials, Market Analysis, and Projections

Introduction to Ipilimumab

Ipilimumab, marketed under the brand name Yervoy, is a monoclonal antibody that targets the anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4). It is primarily used in the treatment of malignant melanoma and has shown promise in various other cancer types. Here, we will delve into the current clinical trials, market analysis, and future projections for ipilimumab.

Clinical Trials Update

Ongoing and Recent Trials

One significant clinical trial involves the use of ipilimumab in combination with nivolumab for treating INI1-negative tumors in children and young adults. This Phase II trial, which started and is expected to complete by December 2025, aims to assess the safety and effectiveness of this combination in patients aged 6 months to 40 years[1].

Another notable trial focuses on the use of nivolumab and ipilimumab in patients with metastatic urothelial carcinoma (mUC). This nonrandomized Phase 2 trial showed that adding high-dose ipilimumab to nivolumab can improve tumor response and survival rates, although it highlighted the need for caution due to significant progression events in some cohorts[4].

Immuno-Oncology Clinical Trials Landscape

The landscape of immuno-oncology clinical trials is expanding rapidly, with over 9,000 active trials in 2022, up from around 4,000 in 2017. This growth is driven by the FDA's approval of several immuno-oncology medications, including ipilimumab, nivolumab, and pembrolizumab. The success of these medications in clinical trials has spurred increased funding and research in this field[3].

Market Analysis

Current Market Size and Growth

The global ipilimumab market was valued at USD 2.026 million in 2021 and is projected to reach USD 4.34 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 10.0% during the forecast period of 2022 to 2029. This growth is largely driven by the increasing prevalence of cancer, particularly melanoma, and the rising healthcare expenditure which improves infrastructure[2].

Market Dynamics

Drivers

• Increasing Prevalence of Cancer: The global burden of cancer is expected to rise significantly, with the International Agency for Research on Cancer (IARC) predicting 27.5 million new cases and 16.3 million deaths by 2040. This increase in cancer cases is a primary driver for the growth of the ipilimumab market[2].
• Healthcare Infrastructure and Expenditure: Rising healthcare expenditure and improvements in healthcare infrastructure, especially in regions like North America and Asia-Pacific, are significant factors contributing to market growth[2].

Opportunities

• Research and Development: The market is fueled by an increase in research and development activities, including the development of new immuno-oncology medications and combination therapies. This provides beneficial opportunities for market growth[2].
• Emerging Markets: The Asia-Pacific region, in particular, presents promising opportunities due to expanding healthcare infrastructure and increasing awareness among patients[5].

Restraints/Challenges

• High Cost of Treatment: The high cost of ipilimumab treatment and potential side effects are significant challenges. Managing these through strategic pricing and enhanced patient education is crucial[5].
• Competition: Competition from other established immunotherapies also poses a challenge to the market growth of ipilimumab[5].

Market Scope and Regional Analysis

Global Market Scope

The global ipilimumab market is segmented by type, application, mechanism of action, dosage, route of administration, end-users, and distribution channels. North America currently dominates the market due to the high prevalence of cancer and the presence of major key players. The Asia-Pacific region is expected to grow significantly during the forecast period due to rising healthcare expenditure and improvements in healthcare infrastructure[2].

Key Market Players

Major players in the ipilimumab market include Bristol-Myers Squibb Company, AstraZeneca, Sanofi, Gilead Sciences, Inc., Merck KGaA, F. Hoffmann-La Roche Ltd., Novartis AG, Merck & Co., Inc., Incyte, and Baxter[2].

Projections and Future Outlook

Market Growth Projections

The ipilimumab market is expected to continue its rapid growth, driven by the increasing prevalence of cancer and advancements in healthcare infrastructure. The market is projected to reach USD 4.34 million by 2029, with a CAGR of 10.0% during the forecast period[2].

Emerging Trends and Opportunities

• Combination Therapies: The potential for combining ipilimumab with other therapies to achieve synergistic effects is a promising area of research. This could expand the indications for ipilimumab and address unmet needs in oncology[5].
• Regulatory Approvals: Recent FDA approvals, such as the approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy for non-small cell lung cancer, indicate a favorable regulatory environment that will support market growth[2].

"The FDA's Real-Time Oncology Review (RTOR) pilot programme was used to review this application, which aims to ensure that safe and effective medicines are offered to patients as soon as feasible."[2]

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the efficacy and safety of ipilimumab in combination with nivolumab for various cancer types, including INI1-negative tumors and metastatic urothelial carcinoma.
• Market Growth: The ipilimumab market is expected to grow significantly, driven by the increasing prevalence of cancer and improvements in healthcare infrastructure.
• Market Dynamics: The market is influenced by factors such as rising healthcare expenditure, research and development activities, and the presence of major key players.
• Future Outlook: The potential for combination therapies and favorable regulatory approvals are key drivers for the future growth of the ipilimumab market.

FAQs

Q: What is ipilimumab used for?

A: Ipilimumab is primarily used for the treatment of malignant melanoma and is being explored for other cancer types, including INI1-negative tumors and metastatic urothelial carcinoma.

Q: What is the current market size of ipilimumab?

A: The global ipilimumab market was valued at USD 2.026 million in 2021 and is projected to reach USD 4.34 million by 2029.

Q: What are the key drivers of the ipilimumab market growth?

A: The key drivers include the increasing prevalence of cancer, rising healthcare expenditure, and advancements in research and development activities.

Q: Which regions are expected to drive the growth of the ipilimumab market?

A: North America currently dominates the market, but the Asia-Pacific region is expected to grow significantly during the forecast period due to rising healthcare expenditure and improvements in healthcare infrastructure.

Q: What are the challenges facing the ipilimumab market?

A: The high cost of treatment, potential side effects, and competition from other established immunotherapies are significant challenges to market growth.

Sources

1. ClinicalTrials.ucsf.edu: Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers.
2. Data Bridge Market Research: Global Ipilimumab Market – Industry Trends and Forecast to 2029.
3. Visiongain: Immuno-Oncology Clinical Trials market is projected to grow at a CAGR of 11.3% by 2033.
4. PubMed: Nivolumab + Ipilimumab as Immunotherapeutic Boost in Metastatic Urothelial Carcinoma: A Nonrandomized Clinical Trial.
5. 360iResearch: Ipilimumab Injection Market Size & Share 2025-2030.