A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT06544655
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 213
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1A: BMS-986484 Dose Escalation BMS-986484 - Part 1B: BMS-986484 + Nivolumab Dose Escalation BMS-986484 - Part 2A: BMS-986484 Dose Expansion BMS-986484 - Part 2B: BMS-986484 + Nivolumab Dose Expansion BMS-986484 - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation BMS-986484 - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation Oxaliplatin - Part 1 Co-Admin: BMS-986484 + Nivolumab BMS-986484 - Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation BMS-986484 - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion BMS-986484 - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion Nivolumab - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion Oxaliplatin - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion Capecitabine - Part 1B: BMS-986484 + Nivolumab Dose Escalation Nivolumab - Part 2B: BMS-986484 + Nivolumab Dose Expansion Nivolumab - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation Nivolumab - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation Capecitabine - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation Fluorouracil - Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation Calcium folinate - Part 1 Co-Admin: BMS-986484 + Nivolumab Nivolumab - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion Fluorouracil - Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion Calcium folinate -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to approximately 2 years Incidence of serious adverse events (SAEs) Up to approximately 2 years Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria Up to approximately 28 days Incidence of AEs leading to discontinuation Up to approximately 2 years Incidence of AEs leading to death Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Up to approximately 2 years Incidence of anti-drug antibodies (ADAs) Up to approximately 2 years Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Up to approximately 2 years Maximum observed concentration (Cmax) Up to approximately 2 years Time of maximum observed concentration (Tmax) Up to approximately 2 years Area under the concentration-time curve (AUC) Up to approximately 2 years Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Up to approximately 2 years
Trial Locations
- Locations (9)
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
Sanford Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
University of Arizona Cancer Center🇺🇸Tucson, Arizona, United StatesAaron Scott, Site 0003Contact520-626-2430