Ovarian Cancer Ovarian carcinoma
Conditions
Interventions
Arm 1:
Pembrolizumab 400 mg (Q6W, 18 cycles)
+
Paclitaxela 80 mg/m2 days 1, 8, 15 of each Q3W-cycle
(± bevacizumab 10 mg/kg Q2Wb)
Arm 2:
Placebo (Q6W, 18 cycles)
+
Paclitaxela 80 mg/m2 days 1, 8, 1
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The below-mentioned inclusion criteria are the most important ones. A complete list of cohort specific inclusion criteria can be found in the protocol. 1. Has 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 carcinoma. 2. Has received 1 or 2 prior lines of systemic therapy for OC, including at least 1 prior platinum-based therapy. 3. Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (ie, platinum-resistant disease). 4. Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using). 5. Is female, and at least 18 years of age, at the time of signing the informed consent. 6. Has an ECOG performance status of 0 to 1 assessed within 3 days before randomization. 7. A female participant is eligible to participate if she is not pregnant or breastfeeding 8. The participant (or legally acceptable representative) has provided documented informed consent for the study 9. Has radiographically evaluable disease 10. Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided 11. Have adequate organ function
Exclusion criteria
Exclusion criteria: The below-mentioned exclusion criteria are the most important ones. A complete list of cohort specific exclusion criteria can be found in the protocol. 1. Has 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. 2. Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy. 3. Has prior disease progression on weekly paclitaxel alone. 4. Has uncontrolled hypertension. Note: only for patients receiving bevacizumab 5. Has current, clinically relevant bowel obstruction. Note: only for patients receiving bevacizumab 6. Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.Note: This applies only to participants who will receive bevacizumab. 7. Has received >2 prior lines of systemic therapy for OC 8. Has received prior systemic anticancer therapy, including investigational agents or maintanance therapy (including bevacizumab maintanance therapy) within 4 weeks before randomization 9. Has received prior radiation therapy within 2 weeks of start of study intervention. 10. Has not recovered adequately from surgery and/or any complications from the surgery. 11.Has received colony-stimulating factors within 4 weeks before randomization. 12. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention 13. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. 14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy within 7 days before the first dose of study medication. 15. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. 16. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable 17. Has severe hypersensitivity (>=Grade 3) to pembrolizumab, paclitaxel, or bevacizumab 18. Has an active autoimmune disease that has required systemic treatment in the past 2 years 19. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 20. Has an active infection requiring systemic therapy 21. Has a known history of HIV infection. 22. Has a known history of Hepatitis B or known active Hepatitis C virus 23. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study 24. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. 25. Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study. 26. Has had an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: - To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to overall survival (OS) - To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression free survival (PFS) - To evaluate the safety and tolerability of pembrolizumab in combination with paclitaxel with or without bevacizumab - To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to Global Health Status/Quality of Life (GHS/QoL) score | — |
Countries
Netherlands
Outcome results
None listed