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Cisplatin+Pembrolizumab+RT in Vulvar Cancer

NCT04430699 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-05

No results posted yet for this 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)

Conditions

  • Vulvar Cancer
  • Vulvar Squamous Cell Carcinoma

Interventions

DRUG

Cisplatin

Participants will be given Cisplatin by intravenous infusion at a predetermined dose 1x weekly up to 8 weeks.

DRUG

Pembrolizumab

Participants will be given Pembrolizumab by intravenous infusion at a predetermined dose 1x every 3 weeks up to 36 weeks.

RADIATION

Radiation Therapy

Standard of care radiation therapy 1x daily up to 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Oladapo Yeku, MD, PHD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2026-04-30
Completion
2028-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430699 on ClinicalTrials.gov