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Platinum-based Chemotherapy
Cisplatin + Pembrolizumab + Radiation Therapy for Vulvar Cancer
Phase 2
Recruiting
Led By Oladapo Yeku, MD, PHD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
Participant must be female, not pregnant, not breastfeeding, and meet the specified contraceptive requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test the hypothesis that the addition of pembrolizumab to the standard of care regimen of cisplatin and radiation therapy will improve outcomes in patients with unresectable vulvar squamous cell carcinoma.
Who is the study for?
This trial is for adult women with vulvar squamous cell carcinoma that can't be removed by surgery or has come back after treatment. They should have measurable disease, an ECOG performance status of 0 or 1, and adequate organ function. Women who are pregnant, breastfeeding, or have had certain treatments recently cannot join.Check my eligibility
What is being tested?
The study tests a combination of Cisplatin (a standard cancer drug), Pembrolizumab (an investigational drug), and Radiation Therapy to treat unresectable vulvar cancer. The goal is to see how effective this trio is compared to current treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, fatigue, skin changes from radiation, nausea from chemotherapy, and increased risk of infections due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a sample of my tumor for testing, not from an area treated with radiation.
Select...
I am a woman, not pregnant, not breastfeeding, and follow the required birth control measures.
Select...
My vulvar cancer cannot be fully removed by surgery and may have spread.
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I am 18 years old or older.
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I can carry out all my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Recurrence Free Survival (RFS)-6 months
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, Cisplatin and Radiation TherapyExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,421 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,033 Total Patients Enrolled
Oladapo Yeku, MD, PHDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an infection.I have not had more than two chemotherapy treatments for my recurrent disease, and I stopped immunotherapy only if I had severe side effects.I have had or currently have lung inflammation treated with steroids.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have active brain metastases or carcinomatous meningitis.I had radiotherapy less than 2 weeks ago.I have not had any cancer besides nonmelanoma skin cancer in the last 5 years.I have not received a live vaccine in the last 30 days.I have a history of Hepatitis B or active Hepatitis C.I can safely receive at least 30 Gy of radiation in 10 sessions.I have recovered from side effects of previous treatments to my normal or mild condition.I have an active tuberculosis infection.My cancer can be measured by scans and has grown in previously treated areas.I have provided a sample of my tumor for testing, not from an area treated with radiation.I am a woman, not pregnant, not breastfeeding, and follow the required birth control measures.I do not have any unmanaged ongoing illnesses.I have been diagnosed with HIV.My vulvar cancer cannot be fully removed by surgery and may have spread.My organs and bone marrow are working well.I have an autoimmune disease treated with medication in the last 2 years.I am 18 years old or older.I can carry out all my daily activities without help.I have been diagnosed with a specific type of skin cancer affecting the vulvar area.I have had issues with abnormal connections between my intestines and bladder.My doctor considers any other cancer I've had as cured.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab, Cisplatin and Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies in this research project?
"The latest information available on clinicaltrials.gov confirms that this trial is currently accepting patients, having been first posted on the 29th of July 2020 and last modified on 4 April 2022."
Answered by AI
Has research been conducted on Cisplatin previously?
"Presently, over 1554 studies are examining Cisplatin with 355 of them in their third stage. Of those research centres, the majority, 69989 to be precise, is located in Shanghai."
Answered by AI
Has the United States Food and Drug Administration sanctioned Cisplatin for public use?
"The safety rating of Cisplatin was determined to be a 2, reflecting the Phase 2 status which indicates that there has been evidence supporting its security, but not efficacy."
Answered by AI
What maladies is Cisplatin typically prescribed to treat?
"Cisplatin is commonly prescribed for the treatment of cancerous tumours. Additionally, it has been used to address conditions like unresectable melanoma, microsatellite instability high and cases with a heightened risk of recurrence."
Answered by AI
How many individuals are actively engaging in this clinical experiment?
"Affirmative. Clinicaltrials.gov information indicates that this study commenced accepting patients on July 29th 2020 and is presently recruiting. The trial site seeks to enroll 24 individuals at a single location."
Answered by AI
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