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

Description

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 or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Conditions

Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms

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Study Overview

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Study Details

Study overview

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 or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

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

Condition
Cervical Cancer
Intervention / Treatment

-

Contacts and Locations

Clovis

Community Cancer Institute, Clovis, California, United States, 93611

Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Hackensack

John Theurer Cancer Center, Hackensack, New Jersey, United States, 07601

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

New York

Local Institution - 0002, New York, New York, United States, 10065

Portland

Providence Cancer Center Oncology and Hematology Care- Eastside, Portland, Oregon, United States, 97213

Nashville

Local Institution - 0063, Nashville, Tennessee, United States, 37067

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
  • * 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, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • * Advanced or metastatic disease 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2026-12-31