What is the mechanism of action of this treatment?

Immune checkpoint inhibitors, such as nivolumab and ipilimumab, work by blocking proteins like PD-1, PD-L1, and CTLA-4 that normally keep the immune system in check. By inhibiting these checkpoints, these drugs enhance the body's immune response against cancer cells. This is particularly important for patients with solid tumors because these tumors often evade the immune system. By reactivating immune cells, checkpoint inhibitors can help to control and potentially shrink tumors, offering a promising treatment option for advanced or metastatic cancers.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly immune checkpoint inhibitors and immune modulators like nivolumab, ipilimumab, and pembrolizumab, often cause immune-related adverse events. These include pneumonitis, colitis, hepatitis, endocrinopathies (such as thyroiditis and adrenal insufficiency), and skin reactions like rash and pruritus. Severe side effects can include grade 3 or 4 toxicities such as severe gastrointestinal issues, severe skin reactions, and infusion-related reactions, resulting from the immune system attacking normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors and immune modulators for the treatment of solid tumors. Nivolumab and ipilimumab have been approved for advanced melanoma and non-small cell lung cancer. Pembrolizumab is approved for melanoma, non-small cell lung cancer, and other solid tumors with high PD-L1 expression. Atezolizumab has been approved for non-small cell lung cancer and renal cell carcinoma. These treatments work by enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising alternatives to BMS-986207 for solid tumor patients include: 1) Nivolumab (Opdivo) - an anti-PD-1 antibody used alone or in combination with other agents like ipilimumab. 2) Pembrolizumab (Keytruda) - another anti-PD-1 antibody, often used in combination with chemotherapy. 3) Atezolizumab (Tecentriq) - an anti-PD-L1 antibody, used alone or with chemotherapy. 4) Relatlimab - a novel LAG-3 inhibitor, often combined with nivolumab. These agents have shown efficacy in various solid tumors, including non-small cell lung cancer, melanoma, and head and neck cancers.

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BMS-986207 + Immunotherapy for Solid Cancers

Phase 1 & 2

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

Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Uncontrolled or significant cardiovascular disease

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-986207 alone and with other drugs, Nivolumab and Ipilimumab, in patients with severe solid cancers. These patients have cancers that are advanced or have spread. The drugs aim to help the immune system recognize and destroy cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors showing at least 1% PD-L1 expression. They should be relatively healthy, able to perform daily activities (ECOG status of 0 or 1), and have measurable disease by scans. People with primary brain tumors, only brain metastases, other active cancers needing treatment, serious heart conditions, or autoimmune diseases can't join.

What is being tested?

The study tests BMS-986207 alone and in combination with Nivolumab or both Nivolumab and Ipilimumab. It aims to find out how safe these treatments are and how well they work against advanced solid tumors that have spread.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs like the lungs or intestines, infusion reactions from the drugs being given into a vein, fatigue, skin issues like rash or itching, hormone gland problems (like thyroid dysfunction), and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has PD-L1 levels of 1% or higher, confirmed by a test within the last 3 months.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured on scans and was checked within the last 28 days.

Exclusion Criteria

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

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My NSCLC has not been treated in its advanced or metastatic stage.

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I have serious heart problems that are not under control.

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I have an autoimmune disease.

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I have another cancer that needs treatment at the same time.

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

Side effects data

From 2022 Phase 2 trial • 1 Patients • NCT05005273

100%

Cardiac arrest

100%

Sepsis

100%

Bronchitis

100%

Blood alkaline phosphatase increased

100%

Blood lactate dehydrogenase increased

100%

Hypoalbuminaemia

100%

Hypokalaemia

100%

Nausea

100%

Hyponatraemia

100%

Eczema

100%

80%

60%

40%

20%

Study treatment Arm

Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo

Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2C: Triplet ExpansionExperimental Treatment3 Interventions

Group II: Part 2B: Expansion Combination TherapyExperimental Treatment2 Interventions

Group III: Part 2A: Expansion MonotherapyExperimental Treatment1 Intervention

Group IV: Part 1C: Triplet CohortExperimental Treatment3 Interventions

Group V: Part 1B: Dose Escalation Combination TherapyExperimental Treatment2 Interventions

Group VI: Part 1A: Dose Escalation MonotherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986207

2022

Completed Phase 2

~110

Nivolumab

2014

Completed Phase 3

~5220

Ipilimumab

2014

Completed Phase 3

~3140

0 / 7Eligibility 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

Immune checkpoint inhibitors, such as nivolumab and ipilimumab, work by blocking proteins like PD-1, PD-L1, and CTLA-4 that normally keep the immune system in check. By inhibiting these checkpoints, these drugs enhance the body's immune response against cancer cells. This is particularly important for patients with solid tumors because these tumors often evade the immune system. By reactivating immune cells, checkpoint inhibitors can help to control and potentially shrink tumors, offering a promising treatment option for advanced or metastatic cancers.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.