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Monoclonal Antibodies
BMS-986360 + Chemotherapy/Nivolumab for Advanced Cancer
Phase 1
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 2 years
Awards & highlights
Study Summary
This trial will test a new drug to fight advanced cancers, either alone or with other treatments.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung cancer and breast cancer, who have tried standard treatments without success. They must be in good physical condition (ECOG 0 or 1) and have a tumor that can be biopsied. People with primary brain tumors or only brain metastases, recent steroid use, other active cancers within the last two years, or specific genetic mutations treatable by targeted therapy are excluded.Check my eligibility
What is being tested?
The study tests BMS-986360 alone and combined with chemotherapy drugs like Docetaxel and Capecitabine or the immunotherapy drug Nivolumab in patients with advanced solid tumors. It aims to find out how safe these treatments are and how well they're tolerated when given together.See study design
What are the potential side effects?
Possible side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; immune-related issues from Nivolumab like skin rash or inflammation of organs; plus any unknown risks from the new drug BMS-986360.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 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 plasma concentration-time curve (AUC)
Maximum observed plasma concentration (Cmax)
Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: BMS-986360 + NivolumabExperimental Treatment2 Interventions
Group II: BMS-986360 + DocetaxelExperimental Treatment2 Interventions
Group III: BMS-986360 + CapecitabineExperimental Treatment2 Interventions
Group IV: BMS-986360Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Docetaxel
1995
Completed Phase 4
~5620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,129,244 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition hasn't improved with standard treatments, including immunotherapy for NSCLC.My advanced lung or triple-negative breast cancer is measurable by specific criteria.I haven't had any cancer except for early skin cancer or non-invasive cancer in the last 2 years.I am fully active or can carry out light work.I have advanced cancer with measurable disease in one of the specified types.I haven't taken high-dose steroids or immunosuppressants recently.I do not have cancer that started in or has only spread to my brain, or if I do, it's under control without new symptoms.My NSCLC may have mutations or hasn't been tested for EGFR, BRAF, ALK, or ROS1.I can provide recent or new biopsy samples for the study.
Research Study Groups:
This trial has the following groups:- Group 1: BMS-986360
- Group 2: BMS-986360 + Docetaxel
- Group 3: BMS-986360 + Nivolumab
- Group 4: BMS-986360 + Capecitabine
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.
What is the distribution of clinical sites involved in this trial?
"Ten recruiting sites are available for this study, such as South Texas Accelerated Research Therapeutics (START) in San Antonio, Cedars-Sinai Medical Center situated in Los Angeles, and Local Institution - 0005 located in Toronto. In addition to these locations there are seven other participating medical centres."
Answered by AI
Is enrollment still open for this particular clinical investigation?
"Data presented on clinicaltrials.gov confirms that this medical research is no longer accepting applicants at the present time. Initially posted in late November 2022, and last edited a couple weeks later, there are still 2502 other trials currently recruiting volunteers across the world."
Answered by AI
Has the FDA accepted BMS-986360 in conjunction with Capecitabine?
"The safety of BMS-986360 in combination with Capecitabine was rated a 1 based on the level of data available, as it is currently only being tested in Phase 1 clinical trials."
Answered by AI
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