Advanced Cancer
Conditions
Keywords
Opdivo®, Immunotherapy
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
Interventions
BIOLOGICALBMS-986406
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Parts 1A, 1B, 1C: * Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease Part 1D: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease. All Parts: * Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Adequate organ function
Exclusion criteria
* Prior organ or tissue allograft * Leptomeningeal metastases * Untreated CNS metastases * Serious or uncontrolled medical disorders Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 100 days |
| Number of participants with serious adverse events (SAEs) | Up to 100 days |
| Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 28 days |
| Number of participants with AEs leading to discontinuation | Up to 100 days |
| Number of participants with death | Up to 100 days |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | Up to 24 months |
| Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma | Up to 24 months |
| Maximum observed plasma concentration (Cmax) | Up to 14 days |
| DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types | Up to 24 months |
| DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer | Up to 24 months |
| Time of maximum observed plasma concentration (Tmax) | Up to 14 days |
| Trough observed plasma concentration (Ctrough) | Up to 14 days |
| Incidence of anti-drug antibody (ADAs) | Up to 14 days |
| Objective response rate (ORR) | Up to 24 months |
Countries
Argentina, Belgium, Japan, South Korea, Spain, United States
Outcome results
None listed