Cisplatin+Pembrolizumab+RT in Vulvar Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04430699
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Vulvar Cancer
  • Vulvar Squamous Cell Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Participants will be given Cisplatin by intravenous infusion at a predetermined dose 1x weekly up to 8 weeks.
  • Pembrolizumab — DRUG
    Participants will be given Pembrolizumab by intravenous infusion at a predetermined dose 1x every 3 weeks up to 36 weeks.
  • Radiation Therapy — RADIATION
    Standard of care radiation therapy 1x daily up to 8 weeks.

Study Details

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)

Key Dates

Start date
Jul 29, 2020
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Jan 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab, Cisplatin and Radiation Therapy
    Treatment period is 36 weeks with 21 day study cycles. Participants will receive cisplatin at a predetermined dose 1x weekly, pembrolizumab at a predetermined dose every 3 weeks, concurrently with daily radiation therapy from week 1 up to week 8. First 3 participants on the study, may skip 1 or 2 pembrolizumab dosages while receiving radiation therapy. Following completion of daily radiation therapy with 1x weekly cisplatin and 1x every 3 weeks pembrolizumab, participants will continue at a pre-determined maintenance dose of pembrolizumab 1x every 3 weeks for a total of 12 cycles or 36 weeks.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 36 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

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By research site
Beth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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