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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 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%
0%
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

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.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,968 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
95,603 Total Patients Enrolled

Media Library

BMS-986207 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02913313 — Phase 1 & 2
Solid Tumors Clinical Trial 2023: BMS-986207 Highlights & Side Effects. Trial Name: NCT02913313 — Phase 1 & 2
BMS-986207 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02913313 — Phase 1 & 2
~11 spots leftby Oct 2025