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Monoclonal Antibodies
BMS-986406 + Combination Therapies for 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
Part 1D: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease
Parts 1A, 1B, 1C: Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and works well when used alone or with another existing cancer drug.
Who is the study for?
This trial is for adults with certain advanced cancers, including lung, kidney, pancreatic, and others. Participants must have a confirmed diagnosis with measurable disease and be in good physical condition. They can't join if they have untreated brain metastases, prior organ transplants or serious medical issues that aren't under control.Check my eligibility
What is being tested?
The study tests BMS-986406 alone or combined with Nivolumab and/or platinum-doublet chemotherapy (PDCT) to see how safe it is and how well people tolerate it. It's aimed at those with advanced tumors to find better treatment options.See study design
What are the potential side effects?
Possible side effects may include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs as well as those related to chemotherapy such as nausea, hair loss, blood cell count changes leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Stage IV A/B non-small cell lung cancer or recurrent disease and haven't had systemic therapy for it.
Select...
My cancer is advanced and cannot be removed by surgery, but it hasn't spread to my brain.
Select...
My cancer can be measured using specific medical guidelines.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with AEs leading to discontinuation
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Number of participants with adverse events (AEs)
+2 moreSecondary outcome measures
DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
Disease control rate (DCR)
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)Experimental Treatment2 Interventions
Group II: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or PaclitaxelExperimental Treatment5 Interventions
Group III: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)Experimental Treatment2 Interventions
Group IV: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)Experimental Treatment2 Interventions
Group V: Part 1A: BMS-986406 (Monotherapy Dose Escalation)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,846 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Stage IV A/B non-small cell lung cancer or recurrent disease and haven't had systemic therapy for it.I have received an organ or tissue transplant from another person.My cancer is advanced and cannot be removed by surgery, but it hasn't spread to my brain.My cancer can be measured using specific medical guidelines.I have brain metastases that have not been treated.My cancer has spread to the lining of my brain and spinal cord.I am fully active or can carry out light work.My organs are working well.I do not have any serious or uncontrolled health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1A: BMS-986406 (Monotherapy Dose Escalation)
- Group 2: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
- Group 3: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
- Group 4: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
- Group 5: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
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 aggregate participant count for this clinical experiment?
"Correct. According to clinicaltrials.gov, this study is still recruiting participants and was first posted on March 31st 2022. It has since seen revisions up until October 24th of the same year - with a goal to enrol 112 patients from 10 different medical centres."
Answered by AI
How many geographical areas are currently hosting this experimental research?
"This clinical trial is actively sourcing patients from a total of 10 medical centres scattered across the nation, with locations in Huntersville, Hackensack and Philadelphia as well as other areas. To lessen any travelling demands associated with enrollment, it would be best to choose the closest site available to you."
Answered by AI
What potential harm can be caused by BMS-986406?
"Our organization assigned BMS-986406 a score of 1 due to the limited evidence available on its safety and efficacy as this is an initial Phase 1 trial."
Answered by AI
Are there still opportunities for enrolment in this clinical investigation?
"Clinicialtrials.gov reports that this clinical trial, which was established on March 31st 2022, is still recruiting new participants. The study's most recent update occurred on October 24th of the same year."
Answered by AI
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