This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants. The main goals of this study are to: * Evaluate the efficacy of BMS-986489 vs durvalumab * Evaluate the safety profile of BMS-986489
This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will receive concurrent chemotherapy and radiotherapy according to standard guidelines for treatment of LS-SCLC without progressive disease prior to randomization. Eligible participants will be randomly assigned to receive either BMS-986489 (atigotatug + nivolumab as a fixed-dose combination; Arm A) or durvalumab (Arm B) as consolidation therapy. Atigotatug is a first-in-class, fully human IgG1 antibody being developed for the treatment of SCLC. Atigotatug specifically binds to fuc-GM1 on the tumor cell. Nivolumab is a monoclonal anti-PD-1 antibody. Combining atigotatug with another immunotherapy may provide enhanced antitumor effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
BMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.
Durvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.
Time frame: From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and
Evaluate the efficacy of BMS-986489 vs durvalumab by Progression Free Survival (PFS).
Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of an event, defined as the first documented radiological progression or death due to any cause.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab Objective Response Rate (ORR).
Objective Response Rate (ORR) is defined as the proportion of participants with BOR of CR or PR according to RECIST v1.1.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Clinical Benefit Rate (CBR).
Clinical Benefit Rate (CBR) is defined as the proportion of participants with BOR of CR or PR, or participants with SD lasting at least 180 days (i.e., ≥6 months) according to RECIST v1.1.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Disease Control Rate (DCR).
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Southern Cancer Center
Daphne, Alabama, United States
RECRUITINGSansum Clinic
Santa Barbara, California, United States
RECRUITINGFlorida Cancer Specialists - South
Fort Myers, Florida, United States
RECRUITINGOcala Oncology Center
Ocala, Florida, United States
RECRUITINGFlorida Cancer Specialists - North
Orange City, Florida, United States
RECRUITINGCancer Care Centers of Brevard
Palm Bay, Florida, United States
RECRUITINGFlorida Cancer Specialists - East
West Palm Beach, Florida, United States
RECRUITINGIllinois Cancer Specialists
Arlington Heights, Illinois, United States
RECRUITINGIllinois Cancer Care
Peoria, Illinois, United States
RECRUITINGIndiana University Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITING...and 17 more locations
Disease Control Rate (DCR) is defined as the proportion of participants with BOR of CR, PR, or SD according to RECIST v1.1
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Duration of Response (DoR).
Duration of Response (DoR) is defined as the duration from the first documented response (Complete Response (CR), Partial Response (PR), or Stable Disease (SD), according to RECIST v1.1) to the date of first documented disease progression or death.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by Time to Progression (TtP).
Time to Progression (TtP) is defined as the time from the date of randomization to the date of first documented disease progression, according to RECIST v1.1.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the efficacy of BMS-986489 vs durvalumab by time to development of central nervous system (CNS) metastasis.
Time to development of central nervous system (CNS) metastasis is defined as the time from the date of randomization to the date of first documented CNS metastasis.
Time frame: Every 2 cycles (8 weeks) from Cycle 1 Day 1, for the first 6 months, then every 3 cycles (12 weeks) until disease progression or death, up to 3 years. Each cycle is 28 days.
Evaluate the number of participants with adverse events following administration of BMS-986489.
Adverse Events to be evaluated per CTCAE v5.0 criteria from first dose of BMS-986489 to 100 days after the last dose of BMS-986489.
Time frame: From Cycle 1 Day 1 to 100 days after the last dose of BMS-986489. Each cycle is 28 days.