Testing BMS-986484 alone and with nivolumab for advanced solid tumors
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
This study is testing a new treatment called BMS-986484, both alone and with another drug called nivolumab, to see if it can help people with advanced solid tumors like lung, colorectal, and pancreatic cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | nivolumab |
| Locations | 11 sites (Tucson, Arizona and 10 other locations) |
| Trial ID | NCT06544655 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of BMS-986484, both as a standalone treatment and in combination with nivolumab, for patients with advanced solid tumors such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Participants must have measurable disease and a performance status of 0 or 1. The trial aims to determine the effectiveness of this immunotherapy approach in managing these aggressive cancers.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced unresectable or metastatic solid tumors like NSCLC, MSS CRC, and PDAC.
Not a fit: Patients with active autoimmune diseases or serious uncontrolled medical disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). * Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). * Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. Exclusion Criteria: * History of or with active interstitial lung disease or pulmonary fibrosis. * Active, known, or suspected autoimmune disease. * Serious uncontrolled medical disorders. * New onset, non-catheter-associated venous thromboembolism within the past 6 months. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Tucson, Arizona and 10 other locations
- Local Institution - 0003 — Tucson, Arizona, United States (Not_yet_recruiting)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Local Institution - 0014 — Aurora, Colorado, United States (Not_yet_recruiting)
- Local Institution - 0018 — Aurora, Colorado, United States (Not_yet_recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Sanford Cancer Center — Sioux Falls, South Dakota, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- St Vincent's Hospital — Darlinghurst, New South Wales, Australia (Recruiting)
- Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.