This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either: Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
456
Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
Overall Survival (OS)
Estimates based on Kaplan-Meier method.
Time frame: From the first dose of study drug up to 24 months
Objective Response Rate (ORR) as Assessed by Investigator
Response is based on RECIST v1.1 criteria.
Time frame: From the first dose of study drug up to 20 months
Disease Control Rate (DCR) as Assessed by Investigator
Response is based on RECIST v1.1 criteria.
Time frame: From the first dose of study drug up to 20 months
Duration of Response (DOR) as Assessed by Investigator
Response is based on RECIST v1.1 criteria.
Time frame: From the first dose of study drug up to 20 months
Time to Response (TTR) as Assessed by Investigator
Response is based on RECIST v1.1 criteria.
Time frame: From the first dose of study drug up to 20 months
Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)
A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.
Time frame: From the first dose of study drug up to 20 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 90 days after last dose (up to 23 months)
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40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)
80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min
1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
University of Alabama at Birmingham
Birmingham, Alabama, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Arizona Oncology
Tucson, Arizona, United States
University of California, San Diego (UCSD)- Moores Cancer Center
La Jolla, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Ventura County Hematology- Oncology
Oxnard, California, United States
University of Florida (UF) Health Cancer Center - Orlando Health
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
...and 107 more locations
Progression-free Survival (PFS) as Assessed by Investigator
Time frame: From the first dose of study drug up to 20 months