Keynote 826
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).
CLINICALTRIALS.GOV IDENTIFIER:
NCT03635567
When speaking to your doctor, please have the trial identifier number available.
All patients who enroll in the trial will receive medication while on the study.
50% will receive pembrolizumab along with chemotherapy
50% will receive placebo along with chemotherapy
Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.
Dates
Conditions
Cervical Cancer
Age Range
18 - No Age Maximum
Sex
Female
If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.
Print this page or email it to your doctor to discuss at your next visit.
CLINICALTRIALS.GOV IDENTIFIER:
NCT03635567
When speaking to your doctor, please have the trial identifier number available.
Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.
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