Advanced Solid Tumors
Conditions
Keywords
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, FOLFOX, CAPOX, Chemotherapy
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).
Interventions
DRUGBMS-986484
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGOxaliplatin
Specified dose on specified days
DRUGCapecitabine
Specified dose on specified days
DRUGFluorouracil
Specified dose on specified days
DRUGCalcium folinate
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | 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 |
Countries
Australia, Canada, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed