What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors, such as nivolumab and ipilimumab, include fatigue, rash, diarrhea, and pruritus. More severe immune-related adverse events can occur, such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroiditis, adrenal insufficiency), and nephritis. These side effects result from the immune system attacking normal tissues in addition to cancer cells. Management often involves corticosteroids or other immunosuppressive agents to mitigate these immune-related toxicities.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Notable approvals include nivolumab and ipilimumab, which are used for advanced melanoma and non-small cell lung cancer. Pembrolizumab has also been approved for multiple solid tumors, including melanoma and non-small cell lung cancer. These treatments work by modulating the immune system to target cancer cells, similar to the investigational drug BMS-986301 being studied in combination with nivolumab and ipilimumab.

What other types of research exist?

Promising novel alternatives to BMS-986301 for solid tumors include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer (KEYNOTE-189). 2) Nivolumab plus ipilimumab, which has demonstrated benefits in various cancers including renal cell carcinoma and melanoma. 3) Atezolizumab plus bevacizumab, particularly for renal cell carcinoma (IMmotion151). 4) Relatlimab and nivolumab combination, which has shown promise in untreated advanced melanoma (RELATIVITY-047). These therapies represent significant advancements in the treatment of solid tumors.

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Immunotherapy

BMS-986301 + Immunotherapy for Cancer

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Must not have

Uncontrolled or significant cardiovascular disease

Other active malignancy requiring concurrent intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986301, either alone or with two other drugs, nivolumab and ipilimumab. It targets cancer patients whose disease did not improve with standard treatments. The drugs aim to boost the body's natural defenses to better identify and destroy cancer cells.

Who is the study for?

This trial is for adults with certain advanced cancers (like lung, skin, kidney, breast, and bladder cancer) that haven't responded to standard treatments. Participants must be in fairly good physical shape (ECOG score of 0 or 1), have seen their cancer grow despite treatment, and agree to use birth control if necessary. People with other active cancers needing treatment or serious heart disease can't join.

What is being tested?

The study is testing BMS-986301 alone or combined with Nivolumab and Ipilimumab in patients whose cancers didn't respond to therapies that boost the immune system's ability to fight cancer. It aims to find the safest dose, how well people tolerate it, any toxic effects at different doses, and the best way to give these drugs.

What are the potential side effects?

Possible side effects include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs such as intestines or lungs which might cause diarrhea or breathing difficulties respectively; also potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced and has not responded to current treatments.

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I am fully active or have some restrictions but can still care for myself.

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My cancer has grown or spread on scans after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart problems that are not under control.

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I am currently being treated for another cancer.

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My cancer originated in my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Group II: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + IpilimumabExperimental Treatment3 Interventions

Group III: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-studyExperimental Treatment3 Interventions

Group IV: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-studyExperimental Treatment3 Interventions

Group V: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986301

2019

Completed Phase 1

~60

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3420

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors, particularly those involving immune modulation like BMS-986301, include immune checkpoint inhibitors such as nivolumab and ipilimumab. These therapies work by blocking proteins that inhibit T-cell activation, thereby enhancing the immune system's ability to recognize and destroy cancer cells. This mechanism is particularly important for solid tumor patients as it offers a therapeutic option when tumors have become resistant to conventional treatments, potentially leading to improved survival and better management of the disease.