Clinical trial NCT06035497: 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)
Official title: A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory T-cell Lymphomas
Keywords: Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Relapsed or Refractory Adult T-cell Leukemia/Lymphoma (R/R ATL)
Golcadomide
BMS-986369
CC-99282
Adult T-cell leukemia/lymphoma (ATL)
Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper (TFH) cell origin
Angioimmunoblastic T-cell lymphoma (AITL)
Follicular T-cell lymphoma (FTCL)
Nodal peripheral T-cell lymphoma with TFH phenotype
Anaplastic large cell lymphoma, ALK-positive (ALCL, ALK+)
Anaplastic large cell lymphoma, ALK-negative (ALCL, ALK-)
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
Extranodal NK/T-cell lymphoma, nasal type (ENKL)
Mycosis fungoides (MF)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria

- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.

i) Adult T-cell leukemia-lymphoma (ATL).

ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.

iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).

v) ALCL, anaplastic lymphoma kinase-negative (ALK-).

vi) Breast implant-associated ALCL.

vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).

viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).

* Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
* Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
* Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.

Exclusion Criteria

* Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
* Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
* Have a life expectancy ≤ 3 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with Dose-Limiting Toxicity (DLT)
timeFrame: Up to 28 days after first dose
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with Electrocardiogram (ECG) abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with Physical Examination (PE) abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 2 years after last does of treatment
measure: Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
timeFrame: Up to 2 years after last dose of treatment
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
measure: Area under the plasma concentration time-curve (AUC)
timeFrame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
measure: Time to peak (maximum) plasma concentration (Tmax)
timeFrame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
measure: Number of participants with AEs
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with TEAEs
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with ECG abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: ECOG PS
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with LVEF assessment abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants with PE abnormalities
timeFrame: Up to 5 weeks after last dose of treatment
measure: Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Time to response (TTR) as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: TTR as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: DOR as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: PFS as assessed by investigator per international consensus response criteria for ATL
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
timeFrame: Up to 4 years after last dose of treatment
measure: Time to next treatment (TTNT)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: 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.
Other outcomes:
Locations:
city: Anjo-shi
country: Japan
facility: Anjo Kosei Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Kamogawa
country: Japan
facility: Kameda General Hospital
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Narita
country: Japan
facility: International University of Health and Welfare Narita Hospital
state: Chiba
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Japan Community Healthcare Organization Kyushu Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosukakyosai
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sasebo
country: Japan
facility: Sasebo City General Hospital
state: Nagasaki
city: Ōmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Itabashiku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Imamura General Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto University
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagasaki
country: Japan
facility: The Japanese Red Cross Nagasaki Genbaku Hospital
city: Oita
country: Japan
facility: Oita Prefectural Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa
country: Japan
facility: Nakagami Hospital Okinawa
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bistol-Myers Squibb
role: STUDY_DIRECTOR
References: