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NCT04430699 · ClinicalTrials.gov registry record · Phase 2
Cisplatin+Pembrolizumab+RT in Vulvar Cancer
A Phase 2 study of Vulvar Cancer and Vulvar Squamous Cell Carcinoma, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT04430699: Active Phase 2 study of Vulvar Cancer and Vulvar Squamous Cell Carcinoma, sponsored by Massachusetts General Hospital.
NCT04430699 is a Phase 2 study of Vulvar Cancer and Vulvar Squamous Cell Carcinoma that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 24 participants, below the 452-participant average among 17 other Vulvar Cancer trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04430699, a Phase 2 study of Vulvar Cancer and Vulvar Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research is being done to see how well the combination of a standard of care drug, investigational drug, and radiation therapy work against unresectable vulvar squamous cell carcinoma. This research study involves the following: * Cisplatin (standard of care drug) * Pembrolizumab (investigational drug) * Radiation Therapy (standard of care intervention)
Primary Outcome
To determine the Overall response rate (ORR) in patients undergoing combination therapy with pembrolizumab and cisplatin-sensitized external beam radiation therapy by RECIST 1.1 criteria. This sample size calculation is based on an ORR of greater than or equal to 60%. For recurrent metastatic disease, there are is no standard of care.The ORR estimation is informed by data showing an ORR of 40% in patients with advanced or recurrent metastatic vulvar cancer treated with platinum-based combinatio
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- RADIATION Radiation Therapy
Study Locations (2)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2028-01-30 |
| Phase | Phase 2 |
What the registry record for NCT04430699 still lists
NCT04430699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 452-participant average among 17 other Vulvar Cancer trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Vulvar Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04430699 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04430699 about?
NCT04430699 is a clinical study titled "Cisplatin+Pembrolizumab+RT in Vulvar Cancer". This research is being done to see how well the combination of a standard of care drug, investigational drug, and radiation therapy work against unresectable vulvar squamous cell carcinoma. This research study involves the following: * Cisplatin (standard of care drug) * Pembrolizumab (investigati...
What is the current status of trial NCT04430699?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-07-29. Estimated completion is 2028-01-30.
What conditions does trial NCT04430699 study?
This clinical trial studies the following conditions: Vulvar Cancer, Vulvar Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04430699?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04430699?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04430699 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04430699's enrollment target sits among peer trials
24 16th of 17 higher than 2 of 17 other Vulvar Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vulvar Cancer 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.
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