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Alkylating agents
Immunotherapy + Chemotherapy for Resectable Head and Neck Cancer
Phase 2
Recruiting
Led By Kartik Sehgal, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial is testing if a combination of immunotherapy and chemo can help treat head and neck cancer before and after surgery.
Who is the study for?
Adults with recurrent head and neck squamous cell carcinoma (HNSCC) eligible for surgery, not pregnant or breastfeeding, willing to use contraception. Must have good organ function, no recent immunotherapy or live vaccines, no other active cancers or severe autoimmune diseases. No prior treatment within 6 months and must be able to provide tissue samples.Check my eligibility
What is being tested?
The trial is testing the combination of pembrolizumab (immunotherapy) with chemotherapy drugs cisplatin, carboplatin, and docetaxel before and after surgery in patients with HNSCC. Pembrolizumab continues for about a year post-surgery to assess effectiveness and safety.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue from pembrolizumab; nausea, kidney issues from cisplatin; blood count changes from carboplatin; hair loss and numbness from docetaxel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Major Pathological Response (mPR)
Secondary outcome measures
Best Radiological Response Rate
Grade 3-5 Treatment-related Toxicity Rate
Median Disease-Free Survival (DFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pre-Operative Treatment + Salvage Surgery + Adjuvant TreatmentExperimental Treatment4 Interventions
Participants will complete study procedures as outlined:
Preoperative Phase:
Mandatory biopsy at baseline.
Neoadjuvant treatment (2 cycles):
Cycles 1 - 2 ---Day 1 of 21-day Cycle: Predetermined doses of Pembrolizumab, Cisplatin (or Carboplatin) and Docetaxel.
Salvage Surgery:
-Primary tumor resection and/or lymph node dissection surgery 3-6 weeks from cycle 2 day 1
Adjuvant Phase:
-3-8 weeks post-surgery and upto a total of 15 cycles
--Cycles 3 - 17
---Day 1 of 21-day cycle: Predetermined dose of Pembrolizumab
Follow up appointments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
CISPLATIN
2011
Completed Phase 3
~280
Carboplatin
2014
Completed Phase 3
~6670
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,949 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,118 Total Patients Enrolled
Kartik Sehgal, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
53 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a male and agree to follow the specified contraception guidelines for 180 days after my last treatment dose.I have received a transplant from another person.I received treatment for head and neck cancer less than 6 months ago.My cancer originates from the nasal area, nasopharynx, or skin.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am currently being treated for an infection.I have cancer that has spread, but not to my brain.My cancer is a type of squamous cell carcinoma in the head or neck area.I am 18 years old or older.I am fully active or able to carry out light work.My heart is healthy enough for this trial, according to NYHA class 2B or better.My blood tests show normal organ function.I still have side effects from cancer treatment, except for hair loss.My oropharyngeal cancer has been tested for HPV.I agree to provide samples for biopsy before treatment and during surgery, and I might volunteer for more if my disease comes back.I have been treated with specific immune therapy drugs before.I have or had lung inflammation that needed steroids.I am not pregnant or breastfeeding if I want to participate in this study.I have not received a live vaccine within the last 30 days.I have another cancer besides the one being studied, but it's not getting worse or treated in the last 2 years.I am not pregnant, not breastfeeding, and either cannot become pregnant or will follow birth control guidelines.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am eligible for additional surgery to remove or repair my cancer.It's been over 6 months since I finished treatment for head and neck cancer before it came back.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-Operative Treatment + Salvage Surgery + Adjuvant Treatment
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.
Has the combination of Pre-Operative Treatment, Salvage Surgery, and Adjuvant Treatment obtained formal approval from the FDA?
"Pre-Operative Treatment + Salvage Surgery + Adjuvant Treatment was deemed to be of a moderate safety risk, given the lack of efficacy data in this Phase 2 trial."
Answered by AI
Is there still an opportunity for individuals to participate in this experiment?
"According to clinicaltrials.gov, the recruitment period for this particular trial has now ceased; it was initially posted on 7/1/2023 and most recently updated on 2/11/2023. Nevertheless, there are 3729 other trials actively seeking candidates at present."
Answered by AI
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