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NCT03635567 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
NCT03635567: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03635567 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 617 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635567, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
Study Summary
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).
Primary Outcome
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed b
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Paclitaxel
- BIOLOGICAL Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2018-10-25 |
| Est. Completion | 2024-06-04 |
| Phase | Phase 3 |
What the finished NCT03635567 record still lists
NCT03635567 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03635567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03635567 about?
NCT03635567 is a clinical study titled "Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/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, recurr...
What is the current status of trial NCT03635567?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2018-10-25. Estimated completion is 2024-06-04.
What interventions are being tested in trial NCT03635567?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Paclitaxel (DRUG), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03635567?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635567's enrollment target sits among peer trials
617 592nd of 2000 higher than 1,408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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