Pembrolizumab + Paclitaxel +/- Bevacizumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+190 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The primary objective is 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Eligibility Criteria

This trial is for individuals with certain types of ovarian cancer who have had 1-2 previous treatments including platinum-based therapy but are now resistant to it. They must be able to undergo chemotherapy, not be pregnant or breastfeeding, and use effective contraception if applicable. People can't join if they've had recent bleeding issues, other active cancers within 3 years, severe allergies to the drugs being tested, uncontrolled high blood pressure, or infections requiring systemic treatment.

Inclusion Criteria

My cancer worsened within 6 months after my last platinum-based chemotherapy.

I am eligible for paclitaxel chemotherapy.

Has provided documented informed consent for the study.

+7 more

Exclusion Criteria

My cancer got worse during or right after my first platinum-based treatment.

I have not had cancer treatment or experimental drugs in the last 4 weeks.

I had radiation therapy less than 2 weeks ago.

+24 more

Participant Groups

The study aims to see if adding Pembrolizumab (an immunotherapy drug) to Paclitaxel chemotherapy (with or without Bevacizumab) improves progression-free survival compared to a placebo plus the same chemo regimen in patients with PD-L1 positive tumors and all participants.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + paclitaxel ± bevacizumabExperimental Treatment4 Interventions

Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Group II: Placebo + paclitaxel ± bevacizumabPlacebo Group4 Interventions

Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Paclitaxel is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Taxol for: