Immunotherapy Combinations for Cancer

No longer recruiting at 53 trial locations
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Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new combinations of immunotherapy drugs for advanced cancers that cannot be surgically removed or have spread. It evaluates the safety and effectiveness of these drug combinations against cancer. The trial includes two groups, each testing a different drug mix: one with relatlimab, nivolumab, and BMS-986205 (an experimental treatment), and the other with relatlimab, nivolumab, and ipilimumab. Individuals with certain advanced cancers who have tried other treatments or have not yet tried immunotherapy might be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining the drugs relatlimab and nivolumab is generally safe and does not cause unexpected problems. Their safety profile is similar to when each drug is used individually.

In another study, combining nivolumab with ipilimumab was linked to various side effects, particularly those affecting the immune system, such as skin changes or inflammation in different body parts. However, adding relatlimab to this combination might increase the risk of heart-related issues.

These findings clarify the potential side effects of these drug combinations. Prospective trial participants should discuss any concerns with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine cutting-edge immunotherapies to tackle cancer in novel ways. Relatlimab, a new addition, targets the LAG-3 protein on immune cells, potentially enhancing the immune response against cancer. Meanwhile, Nivolumab and Ipilimumab are well-known for targeting PD-1 and CTLA-4 pathways, respectively, which are crucial in immune checkpoint blockade. By combining these treatments, the approach aims to boost the immune system more effectively than current options, like traditional chemotherapy or monotherapy immunotherapies, offering hope for better outcomes in cancer treatment.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will evaluate the effectiveness of different immunotherapy combinations for cancer. Participants in Arm A will receive a combination of Relatlimab, Nivolumab, and BMS-986205. Studies have shown that using Relatlimab with Nivolumab can help treat advanced cancers, with patients experiencing stable disease for twice as long compared to standard treatments.

Participants in Arm B will receive Relatlimab, Nivolumab, and Ipilimumab. The combination of Nivolumab and Ipilimumab has improved survival rates more than Ipilimumab alone. Research suggests that these drugs, when used together, can help the immune system better find and fight cancer cells. Overall, these combinations show promising results in improving outcomes for patients with various advanced cancers.13467

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid cancers that have spread and can't be removed by surgery. Participants should be relatively healthy (ECOG status of 0 or 1) and have a tumor that can be measured. They must also provide tissue samples for research. People with brain metastases, lung inflammation history, active cancer in the last two years (except some skin cancers), or recent serious neurological issues cannot join.

Inclusion Criteria

I have tumor tissue available for testing.
I am fully active or can carry out light work.
My cancer is advanced, cannot be surgically removed, and its size can be measured.

Exclusion Criteria

I have had lung inflammation or scarring before.
I haven't had any cancer except for treated skin cancer in the last 2 years.
My cancer has spread to my brain or is only active there.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of relatlimab, nivolumab, and either BMS-986205 or ipilimumab to assess safety and preliminary activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986205
  • Ipilimumab
  • Nivolumab
  • Relatlimab
Trial Overview The study tests combinations of immunotherapy drugs: relatlimab with nivolumab and BMS-986205, or relatlimab with nivolumab and ipilimumab. It aims to find out how safe these combinations are and how well they work against different types of advanced tumors in patients who haven't had immunotherapy before as well as those who have.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment3 Interventions
Group II: Arm AExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

An Investigational Study of Immunotherapy Combinations ...The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS- ...
the phase II FRACTION gastric cancer study - PMCNivolumab-based therapies are efficacious with acceptable safety in patients with gastric cancer (GC) and gastroesophageal junction cancer (GEJC).
Efficacy | Opdualag® (nivolumab and relatlimab-rmbw) for HCPsAll data shown below is 4-year data based on minimum potential follow-up of 45.3 months.2. Overall survival at 4 years ( ...
Bristol Myers Squibb Provides Update on Phase 3 ...RELATIVITY-098 is a randomized Phase 3, double-blind study evaluating adjuvant immunotherapy with Opdualag, the fixed-dose combination of nivolumab and ...
Advanced Melanoma Clinical Trial ResultsHalf the patients on Opdualag went 2X longer without advanced melanoma worsening than those on a standard treatment. In a clinical trial of 714 patients ...
Safety Profile - Opdualag® (nivolumab and relatlimab-rmbw)View safety profile of Opdualag (nivolumab and relatlimab-rmbw) in unresectable or metastatic melanoma. Please see Indications and Important Safety ...
7.opdualag.comopdualag.com/
Advanced Melanoma Treatment | Opdualag® (nivolumab and ...Opdualag is a combination of 2 immunotherapy medicines that works with your own immune system to help fight advanced melanoma, a type of metastatic skin cancer.
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