A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
- Registration Number
- NCT06035497
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of BMS-986369 BMS-986369 -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with treatment-emergent adverse events (TEAEs) Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with Dose-Limiting Toxicity (DLT) Up to 28 days after first dose Phase 1 participants
Number of participants with laboratory abnormalities Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with vital sign abnormalities Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with Electrocardiogram (ECG) abnormalities Up to 5 weeks after last dose of treatment Phase 1 participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants with Physical Examination (PE) abnormalities Up to 5 weeks after last dose of treatment Phase 1 participants
Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL Up to 2 years after last does of treatment Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort
OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR)Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based) Up to 2 years after last dose of treatment Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort
OR is defined as the achievement of PR or CR
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
PFS as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
Disease control is considered to be SD, PR or CRNumber of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
Disease control is considered to be SD, PR or CRNumber of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) Up to 4 years after last dose of treatment PTCL participants
Time to next treatment (TTNT) From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment. Maximum observed plasma concentration (Cmax) Up to Day 8 of Cycle 2 (each cycle is 28 days) Area under the plasma concentration time-curve (AUC) Up to Day 8 of Cycle 2 (each cycle is 28 days) Time to peak (maximum) plasma concentration (Tmax) Up to Day 8 of Cycle 2 (each cycle is 28 days) Number of participants with AEs Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with TEAEs Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with laboratory abnormalities Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with vital sign abnormalities Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with ECG abnormalities Up to 5 weeks after last dose of treatment Phase 2 participants
ECOG PS Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with LVEF assessment abnormalities Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants with PE abnormalities Up to 5 weeks after last dose of treatment Phase 2 participants
Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
OR is defined as the achievement of PR, CRu, or CRNumber of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
OR is defined as the achievement of PR, CRu, or CRNumber of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based). Up to 4 years after last dose of treatment PTCL participants
OR is defined as the achievement of PR or CRNumber of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based). Up to 4 years after last dose of treatment PTCL participants
OR is defined as the achievement of PR or CROverall survival (OS) From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment. Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Disease control is considered to be stable disease (SD), PR, CRu, or CRNumber of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Disease control is considered to be SD, PR, CRu, or CRNumber of participants who achieve CR as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Time to response (TTR) as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
TTR as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL participants
Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL Participants
DOR as assessed by investigator per international consensus response criteria for ATL Up to 4 years after last dose of treatment ATL Participants
Trial Locations
- Locations (40)
Anjo Kosei Hospital
🇯🇵Anjo-shi, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashi, Aichi, Japan
Kameda General Hospital
🇯🇵Kamogawa, Chiba, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
International University of Health and Welfare Narita Hospital
🇯🇵Narita, Chiba, Japan
Aso Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
Japan Community Healthcare Organization Kyushu Hospital
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Yokosukakyosai
🇯🇵Yokosuka, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Sasebo City General Hospital
🇯🇵Sasebo, Nagasaki, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Ōmura, Nagasaki, Japan
Kindai University Hospital- Osakasayama Campus
🇯🇵Osaka-sayama, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashiku, Tokyo, Japan
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Imamura General Hospital
🇯🇵Kagoshima, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
Kumamoto University
🇯🇵Kumamoto, Japan
University Hospital,Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Kyorin University Hospital
🇯🇵Mitaka, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
🇯🇵Nagasaki, Japan
Oita Prefectural Hospital
🇯🇵Oita, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Nakagami Hospital Okinawa
🇯🇵Okinawa, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan