RECRUITING

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

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Conditions

Cervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast NeoplasmsBMS-986340CRCFirst-in-humanGEJHNSCCMSS CRCNivolumabNSCLCSCCHN

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-05-27
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04895709

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
  2. * 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.
  3. * Eastern Cooperative Oncology Group Performance Status of 0 or 1
  4. * Radiographically documented progressive disease on or after the most recent therapy
  5. * 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
  6. * 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
  1. * Women who are pregnant or breastfeeding
  2. * Primary central nervous system (CNS) malignancy
  3. * Untreated CNS metastases
  4. * Leptomeningeal metastases
  5. * Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
  6. * Active, known, or suspected autoimmune disease
  7. * Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  8. * Prior organ or tissue allograft
  9. * Uncontrolled or significant cardiovascular disease
  10. * Major surgery within 4 weeks of study drug administration
  11. * History of or with active interstitial lung disease or pulmonary fibrosis

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Community Cancer Institute
Clovis, California, 93611
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
University of Iowa
Iowa City, Iowa, 52242
United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Local Institution - 0002
New York, New York, 10065
United States
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon, 97213
United States
Local Institution - 0063
Nashville, Tennessee, 37067
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-27
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-05-27
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • 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
  • Carcinoma, Renal Cell
  • Urothelial Carcinoma
  • Pancreatic Adenocarcinoma
  • Melanoma
  • Ovarian Neoplasms
  • Triple Negative Breast Neoplasms

Additional Relevant MeSH Terms

  • 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