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BMS-986340 + Nivolumab/Docetaxel for 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
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
Must not have
Prior organ or tissue allograft
Active, known, or suspected autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, BMS-986340, alone and with other cancer treatments (nivolumab and docetaxel) in patients with advanced solid tumors. The goal is to find out if it is safe and effective in treating these cancers.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried, can't tolerate, or have no other treatment options. They must have measurable disease and provide tumor biopsies for analysis. Not eligible if they had recent major surgery, are pregnant/breastfeeding, have certain lung diseases or autoimmune conditions, untreated brain metastases, or need steroids/immunosuppressants.
What is being tested?
The study tests BMS-986340 alone and combined with Nivolumab (BMS-936558-01) or Docetaxel in patients with various advanced cancers to find safe doses and see how well they work. It's the first time BMS-986340 is being given to humans in this setting.
What are the potential side effects?
Potential side effects may include typical reactions from cancer therapies such as fatigue, nausea, allergic responses to the drugs administered during infusion sessions; organ-specific inflammation; blood cell count changes; increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have a tumor that can be measured and biopsied, not just with a fine needle or from bone.
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My cancer has worsened after my last treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received an organ or tissue transplant from another person.
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I have an autoimmune disease.
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I have or had lung scarring or interstitial lung disease.
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My cancer originated in my brain or spinal cord.
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I have serious heart problems that are not under control.
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I have not had major surgery in the last 4 weeks.
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I am not pregnant or breastfeeding.
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I have brain metastases that have not been treated.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I haven't taken steroids or immunosuppressants in the last 14 to 30 days.
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
5Treatment groups
Experimental Treatment
Group I: Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2A: BMS-986340 Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental Treatment2 Interventions
Group V: Part 1A: BMS-986340 Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
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 Squamous Cell Carcinoma (SCC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as those inhibiting the epidermal growth factor receptor (EGFR), work by blocking specific molecules involved in tumor growth and progression.
Immunotherapies, like nivolumab, enhance the body's immune response against cancer cells by inhibiting checkpoints that suppress immune activity. Chemotherapy agents, such as docetaxel, disrupt cell division and induce apoptosis in rapidly dividing cancer cells.
These mechanisms are crucial for SCC patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and providing options when resistance to one type of treatment develops.
Identification and validation of novel prognostic markers in Renal Cell Carcinoma.Emerging biological treatments for uterine cervical carcinoma.Novel agents in the treatment of lung cancer: Fourth Cambridge Conference.
Identification and validation of novel prognostic markers in Renal Cell Carcinoma.Emerging biological treatments for uterine cervical carcinoma.Novel agents in the treatment of lung cancer: Fourth Cambridge Conference.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,690 Previous Clinical Trials
4,096,635 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ or tissue transplant from another person.I have an autoimmune disease.I have or had lung scarring or interstitial lung disease.My cancer originated in my brain or spinal cord.I have serious heart problems that are not under control.I have not had major surgery in the last 4 weeks.I am not pregnant or breastfeeding.I have brain metastases that have not been treated.My cancer has spread to the lining of my brain and spinal cord.I can provide fresh biopsy samples before and during treatment for testing.I haven't taken steroids or immunosuppressants in the last 14 to 30 days.I have received all standard treatments for my cancer, except docetaxel in advanced stages.I am fully active or can carry out light work.I have a tumor that can be measured and biopsied, not just with a fine needle or from bone.My advanced cancer has not responded to, or I cannot tolerate, current treatments.My cancer has worsened after my last treatment.I have no other cancers needing treatment or active in the last 2 years.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1C: BMS-986340 + Docetaxel Dose Escalation
- Group 2: Part 2B: BMS-986340 + Nivolumab Dose Expansion
- Group 3: Part 2A: BMS-986340 Dose Expansion
- Group 4: Part 1B: BMS-986340 + Nivolumab Dose Escalation
- Group 5: Part 1A: BMS-986340 Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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