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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing an experimental medication, BMS-986207, to see if it is safe and effective when used alone or in combination with other existing medications to treat advanced solid cancers.
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.Check my eligibility
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.See study design
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 belowSelect...
My cancer has PD-L1 levels of 1% or higher, confirmed by a test within the last 3 months.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer can be measured on scans and was checked within the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of AEs leading to discontinuation
Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Incidence of Adverse Events (AEs)
+4 moreSecondary outcome measures
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Incidence of anti-drug antibody (ADA)
Maximum observed serum concentration (Cmax)
+4 moreSide effects data
From 2022 Phase 2 trial • 1 Patients • NCT05005273100%
Hypoalbuminaemia
100%
Hypokalaemia
100%
Blood lactate dehydrogenase increased
100%
Sepsis
100%
Nausea
100%
Blood alkaline phosphatase increased
100%
Hyponatraemia
100%
Cardiac arrest
100%
Eczema
100%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nivolumab 360 mg + Ipilimumab 1 mg/kg + BMS-986207 600 mg
Nivolumab 360 mg + Ipilimumab 1 mg/kg + Placebo
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
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,413 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
94,422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My NSCLC has not been treated in its advanced or metastatic stage.My cancer has PD-L1 levels of 1% or higher, confirmed by a test within the last 3 months.I have serious heart problems that are not under control.I have an autoimmune disease.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be measured on scans and was checked within the last 28 days.I have another cancer that needs treatment at the same time.My cancer has spread to my brain but is under control.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare centers are conducting this experiment?
"This research is being conducted in multiple sites, such as the John Theurer Cancer Center at Hackensack University Medical Center (New jersey), University Health Network - Princess Margaret Cancer Centre (Toronto, Ontario) and a Local Institution based in Salt Lake City, Utah."
Answered by AI
What is the current scope of this research's sample population?
"This medical trial necessitates the enrollment of 241 eligible participants. Patients located in John Theurer Cancer Center at Hackensack University Medical Center or University Health Network - Princess Margaret Cancer Centre can partake in this clinical study."
Answered by AI
Are there any previous investigations that have utilized BMS-986207?
"BMS-986207 was initially tested in 2009 at the Texas Children's Hospital. Since then, a full 365 studies have been completed and 765 are actively recruiting participants - many of which are located in Hackensack, New jersey."
Answered by AI
What ailments is BMS-986207 typically employed to remedy?
"BMS-986207 offers a promising treatment solution for anti-angiogenic therapy, malignant neoplasms, and unresectable melanoma."
Answered by AI
Is enrollment currently open for this trial?
"The clinicaltrial.gov website shows that this research is actively seeking out participants; it was initially posted on November 30th, 2016 and most recently amended on November 1st, 2022."
Answered by AI
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