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BMS-986449 + Nivolumab for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
Summary
This trial tests a new cancer drug to see if it's safe and effective for treating advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that can't be surgically removed or have spread (metastatic), and who haven't responded to, can't receive, or had adverse reactions to standard treatments. Part of the study focuses on those with specific cancers like non-small cell lung cancer and triple-negative breast cancer.Check my eligibility
What is being tested?
The study is testing BMS-986449 both alone and combined with Nivolumab to see how safe they are and if they work in treating various advanced solid tumors. Participants will be given these drugs to assess their effectiveness against the tumors.See study design
What are the potential side effects?
While not specified here, common side effects for drugs like BMS-986449 and Nivolumab may include fatigue, nausea, skin reactions at the injection site, immune-related issues such as inflammation in organs, potential infections due to lowered immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of deaths
Number of participants with AEs leading to discontinuation
Number of participants with Adverse Events (AEs)
+2 moreSecondary outcome measures
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Maximum observed plasma concentration (Cmax)
Time of maximum observed concentration within a dosing interval (Tmax)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohortsExperimental Treatment1 Intervention
Group II: Dose Escalation: BMS-986449 monotherapyExperimental Treatment1 Intervention
Group III: Dose Escalation: BMS-986449 + nivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,649 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried or cannot take current treatments for my condition.I've had severe side effects from previous immune therapy.I have had recent stomach or intestine problems or surgery that could affect how I absorb medication.I do not have any major health issues that would affect my participation in the study.My cancer is advanced, cannot be surgically removed, and can be measured for changes.I have non-small cell lung cancer.I have a solid tumor cancer of any type.My breast cancer is triple-negative.I must or have already provided a tumor biopsy unless it's medically unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation: BMS-986449 monotherapy
- Group 2: Dose Escalation: BMS-986449 + nivolumab
- Group 3: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
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.
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