Trial · NCT04430699
Cisplatin+Pembrolizumab+RT in Vulvar Cancer
NCT04430699, Phase 2, Active not recruiting, Massachusetts General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cisplatin+Pembrolizumab+RT in Vulvar Cancer. Trials, record NCT04430699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04430699
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cisplatin+Pembrolizumab+RT in Vulvar Cancer
- NCT number
- NCT04430699
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Vulvar Cancer, Vulvar Squamous Cell Carcinoma
- Interventions
- Cisplatin, Pembrolizumab, Radiation Therapy
- First posted
- 2020-06-12
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | Up to 36 weeks | 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 combination therapy. Single agent chemotherapy has an ORR of about 12% (5). Patients with primary disease who are not candidates for upfront surgery have a reported response rates from 55% to 64%. |
| Secondary | Recurrence Free Survival (RFS)-6 months | 6 months | To determine the 6-month Recurrence Free Survival (RFS) in patients with locally advanced, unresectable, or recurrent metastatic vulvar cancer treated with concurrent cisplatin-sensitized radiation therapy and pembrolizumab. A point estimate with exact 95% CI and Kaplan-Meier estimate will be used for the RFS distribution. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32928237 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04430699
GET https://conductscience.org/api/trials/v1/NCT04430699/registered