ACTIVE_NOT_RECRUITING

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

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Conditions

Advanced Malignant TumorsColorectal CancerCRCRenal Cell CarcinomaRCCNon-Small Cell Lung CancerNSCLCCancerOncologyPhase 1Solid Tumor

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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

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Official Title

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Quick Facts

Study Start:2025-03-25
Study Completion:2027-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06764771

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. * Participant must be ≥ 18 years of age.
  2. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
  3. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
  4. * Parts 2A, 1D, 2D: ccRCC.
  5. * Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
  6. * Participants must have measurable disease per RECIST v1.1.
  1. * Untreated central nervous system (CNS) metastases.
  2. * Leptomeningeal metastasis (carcinomatous meningitis).
  3. * Impaired cardiac function or clinically significant cardiac disease.
  4. * For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0021
Hackensack, New Jersey, 07601
United States
Local Institution - 0020
Allentown, Pennsylvania, 18103
United States
Local Institution - 0024
Germantown, Tennessee, 38138
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 Date2025-03-25
Study Completion Date2027-10-15

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2027-10-15

Terms related to this study

Keywords Provided by Researchers

  • Colorectal Cancer
  • CRC
  • Renal Cell Carcinoma
  • RCC
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Cancer
  • Oncology
  • Phase 1
  • Solid Tumor

Additional Relevant MeSH Terms

  • Advanced Malignant Tumors