Ovarian Fallopian Tube or Primary Peritoneal Trial - MK7684A-005 (KEYVIBE-005)

Status:

Recruiting

Disease Site:

Ovarian Fallopian Tube or Primary Peritoneal

Phase:

Phase II

Official Title:

MK7684A-005 (KEYVIBE-005) MULTICENTER, OPEN-LABEL, PHASE 2 BASKET STUDY OF MK-7684A, A CO-FORMATION OF VIBOSTOLIMAB WITH PEMBROLIZUMAB, WITH/WITHOUT OTHER ANTICANCER THERAPIES IN PARTCIPANTS WITH SELECTED SOLID TUMORS

NCT ID:

NCT#05007106

Link to Full Details:

clinicaltrials.gov/show/NCT05007106

Description:

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

Eligibility:

Female – 18 years and older

Inclusion Criteria:

Stage III or IV high-grade serous
Must not have received primary debulking surgery and is a candidate for interval debulking surgery
Must start Lead-In chemo within 8 weeks of first diagnostic tumor tissue biopsy
Must be a candidate for carbo/taxol to be administered in the neoadjuvant setting
CA125 ≥ 25
Must be BRCA1/BRCA2 non-mutated and HRD negative (AS DETERMINED BY CENTRAL LAB- 3 WEEKS FOR RESULTS)

Exclusion Criteria:

Mucinous, germ cell, endometrioid, clear cell, carcinosarcoma or borderline tumors of the ovary
Bowel obstruction, abd fistula, GI perforation related to underlying ovarian cancer
Factor V Leiden or other inherited thrombophilia