Status:
COMPLETED
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (...
Eligibility Criteria
Inclusion
- 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
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05298592
Start Date
March 31 2022
End Date
August 16 2024
Last Update
September 26 2024
Active Locations (29)
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1
Local Institution - 0021
Birmingham, Alabama, United States, 35213
2
University California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
3
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States, 90025
4
UCLA Health
Los Angeles, California, United States, 90404