A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)

The purpose of this research is to:

• Test the safety of pembro plus paclitaxel, with or without bevacizumab compared to placebo plus paclitaxel, with or without bevacizumab
• See how well pembro plus paclitaxel with or without bevacizumab works to control ovarian cancer compared to placebo plus paclitaxel, with or without bevacizumab
• See if participants who get pembro plus paclitaxel, with or without bevacizumab, have a better quality of life compared to those who get placebo plus paclitaxel, with or without bevacizumab

Pembro has been approved for people with various cancers. It has not been approved for ovarian cancer and is considered investigational in this study.

Pembrolizumab with paclitaxel or docetaxel (as applicable) with or without bevacizumab as used in combination for this study is investigational.

Paclitaxel, docetaxel and bevacizumab are approved treatments for ovarian cancer.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

• Females, ages 18 years or older
• Histologically confirmed epithelial (including high-grade serous or predominantly serous, low-grade serous, any-grade endometrioid, malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinomaParticipants with M2 marrow or better
• Has received 1 or 2 prior lines of systemic therapy for OC, including at least 1 prior platinum-based therapy
• Additional eligibility in protocol

• Nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner’s tumor and undifferentiated carcinoma
• Pregnancy/breastfeeding
• Primary platinum-refractory disease, defined as disease that has progressed per RECIST 1.1 while receiving first-line platinum-based therapy
• Prior disease progression on weekly paclitaxel alone
• Uncontrolled hypertension
• Current, clinically relevant bowel obstruction
• History of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization
• Known active CNS metastases and/or carcinomatous meningitis
• Additional ineligibility in protocol

For additional information, please see: https://www.clinicaltrials.gov/ct2/show/ NCT05116189