A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
- Conditions
- Advanced Cancer
- Interventions
- Registration Number
- NCT05298592
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 154
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
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1A: BMS-986406 (Monotherapy Dose Escalation) BMS-986406 - Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) BMS-986406 - Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation) Nivolumab - Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) BMS-986406 - Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion) Nivolumab - Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) BMS-986406 - Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel BMS-986406 - Part 2: BMS-986406 + Nivolumab (Expansion Cohorts) Nivolumab - Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel Nivolumab - Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel Pemetrexed - Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel Carboplatin - Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of anti-drug antibody (ADAs) Up to 14 days Objective response rate (ORR) Up to 24 months 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 DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer Up to 24 months 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 Maximum observed plasma concentration (Cmax) Up to 14 days Time of maximum observed plasma concentration (Tmax) Up to 14 days Trough observed plasma concentration (Ctrough) Up to 14 days
Trial Locations
- Locations (29)
Local Institution - 0021
🇺🇸Birmingham, Alabama, United States
University California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Local Institution - 0001
🇺🇸Hackensack, New Jersey, United States
Carolina BioOncology Institute, PLLC
🇺🇸Huntersville, North Carolina, United States
Sanford Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
Mary Crowley Cancer Research - Medical City Hospital
🇺🇸Dallas, Texas, United States
Local Institution - 0023
🇦🇷Rosario, Santa Fe, Argentina
Local Institution - 0006
🇺🇸Richmond, Virginia, United States
Local Institution - 0029
🇦🇷Viedma, Rio Negro, Argentina
Local Institution - 0028
🇦🇷Buenos Aires, Argentina
Local Institution - 0032
🇦🇷Cordoba, Argentina
Local Institution - 0018
🇧🇪Brussel (Jette), Brussel, Belgium
Local Institution - 0015
🇧🇪Edegem, MA, Belgium
Local Institution - 0012
🇧🇪Brussels, Belgium
Local Institution - 0031
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0026
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Local Institution - 0024
🇰🇷Seoul, Korea, Republic of
Local Institution - 0027
🇰🇷Seoul, Korea, Republic of
Local Institution - 0025
🇰🇷Seoul, Korea, Republic of
Local Institution - 0008
🇪🇸Malaga, Andaluca, Spain
Local Institution - 0030
🇪🇸Barcelona, Spain
Local Institution - 0017
🇪🇸Barcelona, Spain
Institut Catala dOncologia ICO - Hospital Duran i Reynals Location
🇪🇸Barcelona, Spain
Local Institution - 0014
🇪🇸Madrid, Spain
Local Institution - 0009
🇪🇸Madrid, Spain
Local Institution - 0016
🇪🇸Madrid, Spain
Local Institution - 0033
🇪🇸Pamplona, Spain