The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
200 mg by IV infusion on Day 1 of each 21-day cycle
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
Blood samples were collected to determine levels of ctDNA. The fold change in the mean mutant/tumor molecules per mL (MTM/mL) at Cycle 3 from baseline is presented.
Time frame: Baseline and Week 7
Participants With Surgery and Pathological Complete Response (pCR): Change From Baseline in ctDNA
Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. Per protocol, change from baseline in ctDNA in participants with surgery and pCR was reported.
Time frame: Baseline and Week 12
Association of Change From Baseline in ctDNA With pCR
Blood samples were collected to determine levels of ctDNA. pCR was defined as all surgical specimens collected during the interval debulking surgery microscopically negative for residual tumor. pCR rate was defined as percentage of participants with pCR. Per protocol, the association of change from baseline in ctDNA with pCR in participants with surgery and pCR was reported.
Time frame: Baseline and Week 12
Participants With Surgery and Chemotherapy Response Score (CRS): Change From Baseline in ctDNA
Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. Per protocol, change from baseline in ctDNA in participants with surgery and CRS was reported.
Time frame: Baseline and Week 12
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According to local practice and at the choice of the investigator.
800 mg by IV infusion on Day 1 of each 21-day cycle
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)
Aurora, Colorado, United States
Mayo Clinic in Florida ( Site 0101)
Jacksonville, Florida, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 0110)
Miami, Florida, United States
Northwestern Memorial Hospital ( Site 0104)
Chicago, Illinois, United States
Washington University ( Site 0113)
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey ( Site 0114)
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute ( Site 0106)
Buffalo, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0102)
New York, New York, United States
...and 35 more locations
Association of Change From Baseline in ctDNA With CRS3
Blood samples were collected to determine levels of ctDNA. CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, the association of change from baseline in ctDNA with CRS3 in participants with surgery and CRS was reported.
Time frame: Baseline and Week 12
pCR Rate
pCR rate was defined as the percentage of participants with all surgical specimens collected during the interval debulking surgery that were microscopically negative for residual tumor. The pCR rate as assessed by local pathologist was reported.
Time frame: Up to approximately 12 weeks
CRS3 Rate
CRS is a 3-tiered scoring system (CRS1-3) based on the pathological analysis of surgically removed omental masses. CRS was defined as CRS1 (minimal or no tumor response, mainly viable tumor), CRS2 (appreciable tumor response amidst viable tumor that is readily identifiable and regularly distributed), and CRS3 (complete or near-complete response, characterized by the lack of residual tumor cells in the omentum or presence of tumor foci up to 2 mm maximum size); higher values indicate greater response. CRS3 rate was defined as percentage of participants with CRS3. Per protocol, CRS3 rate as assessed by local pathologist was reported.
Time frame: Up to approximately 12 weeks
Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.
Time frame: Up to approximately 26 months
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study intervention due to an AE was reported.
Time frame: Up to approximately 28 weeks