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NCT04221945 · ClinicalTrials.gov registry record · Phase 3
Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,060
- Enrollment target
NCT04221945: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT04221945 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,060 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221945, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,060 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
Primary Outcome
PFS is 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, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Cisplatin
- RADIATION Brachytherapy
- RADIATION External Beam Radiotherapy (EBRT)
- DRUG Placebo for pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,060 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2026-01-26 |
| Phase | Phase 3 |
What the finished NCT04221945 record still lists
NCT04221945 is an interventional study that assigns participants to a tested intervention. Its 1,060 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04221945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04221945 about?
NCT04221945 is a clinical study titled "Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)". The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradioth...
What is the current status of trial NCT04221945?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,060 participants. The study started on 2020-05-12. Estimated completion is 2026-01-26.
What interventions are being tested in trial NCT04221945?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Brachytherapy (RADIATION), External Beam Radiotherapy (EBRT) (RADIATION), Placebo for pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04221945?
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 NCT04221945's enrollment target sits among peer trials
1,060 275th of 2000 higher than 1,726 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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