A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05298592 Recruiting March 28, 2022 June 30, 2022

study description
Brief Summary

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.

Condition or Disease: Advanced Cancer
Intervention/treatment: Biological: BMS-986406
Biological: Nivolumab
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 112 participants
Allocation : Non-Randomized
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Actual Study Start Date: March 2022
Estimated Primary Completion Date: April 2026
Estimated Study Completion Date: July 2026

Arms and interventions
Arm Intervention/treatment
Experimental: Part 1A: BMS-986406 (Monotherapy Dose Escalation)
Biological: BMS-986406
Specified dose on specified days
Experimental: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
Biological: BMS-986406
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
Biological: BMS-986406
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
Biological: BMS-986406
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 100 days ]
2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 100 days ]
3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 28 days ]
4. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 100 days ]
5. Number of participants with death [ Time Frame: Up to 100 days ]
Secondary Outcome Measures: 1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 14 days ]
2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 14 days ]
3. Trough observed plasma concentration (Ctrough) [ Time Frame: Up to 14 days ]
4. Incidence of anti-drug antibody (ADAs) [ Time Frame: Up to 14 days ]
5. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
6. Disease control rate (DCR) [ Time Frame: Up to 24 months ]
7. Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma [ Time Frame: Up to 24 months ]
8. DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer [ Time Frame: Up to 24 months ]
9. DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types [ Time Frame: Up to 24 months ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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 Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma) Eastern Cooperative Oncology Group Performance Status of 0 or 1 Adequate organ function

Exclusion Criteria:

Prior organ or tissue allograft Leptomeningeal metastases Untreated CNS metastases Serious or uncontrolled medical disorders

Other protocol-defined inclusion/exclusion criteria apply


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and Site #.

Locations
United States, California Local Institution Los Angeles
United States, New Jersey Hackensack University Medical Center Hackensack
United States, North Carolina Carolina Biooncology Institute, Pllc Huntersville
United States, Pennsylvania Fox Chase Cancer Center Philadelphia
United States, Texas Local Institution Dallas
United States, Virginia Local Institution Richmond
Spain Local Institution Barcelona
Spain Local Institution Malaga
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05298592     
Other Study ID Numbers : CA111-001, 2021-006872-17, U1111-1270-3670
First Posted : March 28, 2022
Last Update Posted : June 30, 2022
Last Verified : June 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Opdivo® Immunotherapy