RECRUITING

A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

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 and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Official Title

A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies

Quick Facts

Study Start:2024-10-10
Study Completion:2027-10-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06544655

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. * Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
  2. * Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
  3. * Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  1. * History of or with active interstitial lung disease or pulmonary fibrosis.
  2. * Active, known, or suspected autoimmune disease.
  3. * Serious uncontrolled medical disorders.
  4. * New onset, non-catheter-associated venous thromboembolism within the past 6 months.
  5. * Other protocol-defined Inclusion/Exclusion criteria apply.

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)

Local Institution - 0003
Tucson, Arizona, 85716
United States
Local Institution - 0007
Los Angeles, California, 90033
United States
Local Institution - 0014
Aurora, Colorado, 80045
United States
Local Institution - 0018
Aurora, Colorado, 80045
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Local Institution - 0004
Sioux Falls, South Dakota, 57104
United States
NEXT Oncology
San Antonio, Texas, 78229
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 Date2024-10-10
Study Completion Date2027-10-14

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2027-10-14

Terms related to this study

Keywords Provided by Researchers

  • Opdivo®
  • Immunotherapy
  • BMS-986484
  • Non-small cell lung cancer (NSCLC)
  • Microsatellite stable (MSS) colorectal carcinoma (CRC)
  • Pancreatic ductal adenocarcinoma (PDAC)
  • Gastric/gastroesophageal junction adenocarcinoma (G/GEJC)
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • anti-CD40
  • anti-FAP

Additional Relevant MeSH Terms

  • Advanced Solid Tumors