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A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT04895709

  • Recruitment Status

    Recruiting

  • First Posted

    May 20, 2021

  • Last update posted

    April 22, 2022

Study Description

Brief summary:

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

  • Condition or Disease:Cervical Cancer
    Gastric/Gastroesophageal Junction Adenocarcinoma
    Microsatellite Stable Colorectal Cancer
    Non-Small-Cell Lung Cancer
    Squamous Cell Carcinoma of Head and Neck
  • Intervention/Treatment: Drug: BMS-986340
    Drug: BMS-936558-01
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 185 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
  • Actual Study Start Date: May 2021
  • Estimated Primary Completion Date: March 2024
  • Estimated Study Completion Date: August 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A: BMS-986340 Dose Escalation
Drug: BMS-986340
Specified dose on specified days
Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation
Drug: BMS-986340
Specified dose on specified days

Drug: BMS-936558-01
Specified dose on specified days
Experimental: Part 2A: BMS-986340 Dose Expansion
Drug: BMS-986340
Specified dose on specified days
Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion
Drug: BMS-986340
Specified dose on specified days

Drug: BMS-936558-01
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
  • 2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
  • 3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 120 weeks ]
  • 4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
  • 5. Incidence of AEs leading to death [ Time Frame: Up to 120 weeks ]
  • 6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 120 weeks ]
  • 7. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 120 weeks ]
  • 8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 120 weeks ]
  • Secondary Outcome Measures: 1. Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • 2. PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • 3. PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) [ Time Frame: Up to 120 weeks ]
  • 4. PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  • 5. PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • 6. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • 7. PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [ Time Frame: Up to 120 weeks ]
  • 8. PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  • 9. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
  • 10. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
  • 11. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • 12. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • 13. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • 14. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 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: Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Radiographically documented progressive disease on or after the most recent therapy Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant Exclusion Criteria: Women who are pregnant or breastfeeding Primary central nervous system (CNS) malignancy Untreated CNS metastases Leptomeningeal metastases Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment Active, known, or suspected autoimmune disease Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment Prior organ or tissue allograft Uncontrolled or significant cardiovascular disease Major surgery within 4 weeks of study drug administration History of or with active interstitial lung disease or pulmonary fibrosis 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 the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
La Jolla

United States, New Jersey
John Theurer Cancer Center
Hackensack

United States, New York
Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protoco
New York

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, Oregon
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland

Canada, Alberta
Local Institution
Edmonton

Canada, Ontario
Local Institution - 0009
Toronto

Canada, Quebec
Local Institution
Montreal

Canada
Local Institution - 0016
Ottawa

Germany
Local Institution
Dresden

Germany
Local Institution
Essen

Germany
Local Institution
Frankfurt

Germany
Local Institution
Würzburg

Italy
Local Institution
Milano

Italy
Local Institution
Rozzano

Italy
Local Institution
Siena

Spain
Local Institution
Badalona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Pamplona

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04895709 History of Changes
  • Other Study ID Numbers: CA052-002, 2021-001188-26, U1111-1265-4508
  • First Posted: May 20, 2021 Key Record Dates
  • Last Update Posted: April 22, 2022
  • Last Verified: April 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: BMS-986340
    Cervical Cancer
    CRC
    First-in-human
    GEJ
    Gastric/Gastroesophageal Junction Adenocarcinoma
    HNSCC
    Microsatellite Stable Colorectal Cancer
    MSS CRC
    Nivolumab
    Non-Small-Cell Lung Cancer
    NSCLC
    SCCHN
    Squamous Cell Carcinoma of Head and Neck
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung
    Colorectal Neoplasms
    Carcinoma, Squamous Cell
    Adenocarcinoma
    Uterine Cervical Neoplasms
    Esophageal Neoplasms
    Squamous Cell Carcinoma of Head and Neck
    Carcinoma
    Neoplasms, Glandular and Epithelial
    Neoplasms by Histologic Type
    Neoplasms
    Lung Neoplasms
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Lung Diseases
    Respiratory Tract Diseases
    Carcinoma, Bronchogenic
    Bronchial Neoplasms
    Intestinal Neoplasms
    Gastrointestinal Neoplasms
    Digestive System Neoplasms
    Digestive System Diseases
    Gastrointestinal Diseases
    Colonic Diseases
    Intestinal Diseases
    Rectal Diseases
    Neoplasms, Squamous Cell
    Uterine Neoplasms
    Genital Neoplasms, Female
    Urogenital Neoplasms
    Uterine Cervical Diseases
    Uterine Diseases
    Head and Neck Neoplasms
    Esophageal Diseases