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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 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called BMS-986360, alone or with other treatments, in patients with advanced cancers to see if it is safe and can help fight the disease.
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.
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.
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 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
~3960
Docetaxel
1995
Completed Phase 4
~6550
Nivolumab
2014
Completed Phase 3
~5220
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
The most common treatments for solid tumors include immune modulators and targeted cancer therapies. Immune modulators, such as nivolumab, enhance the body's immune response by blocking proteins like PD-1 or PD-L1, which tumors use to evade immune detection.
Targeted cancer therapies focus on specific molecules involved in tumor growth and progression, such as tyrosine kinases. These treatments are important for solid tumor patients as they provide more precise and often less toxic alternatives to traditional chemotherapy, potentially leading to better outcomes and improved quality of life.
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,793 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.
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