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Alkylating agents
Pembrolizumab + Chemotherapy for Head and Neck Cancer
Phase 2
Recruiting
Led By Ari Rosenberg, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have normal organ and marrow function as defined by clinical lab values
Eastern Cooperative Oncology Group performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial aims to find out if a blood test can predict who will respond best to chemo + immunotherapy for head and neck cancer. It will last two years.
Who is the study for?
Adults with confirmed recurrent or metastatic head and neck cancer, who haven't had systemic therapy for this setting, can join. They must have a performance status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but can do light work), measurable disease, normal organ/marrow function, and provide tissue for PD-L1 analysis. Women must not be pregnant/breastfeeding and agree to contraception; men with partners capable of pregnancy must also use contraception.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab combined with chemotherapy drugs Carboplatin and Paclitaxel in patients with head and neck cancer. It aims to see if using a blood test to measure tumor DNA helps guide the intermittent addition of chemotherapy to immunotherapy compared to just immunotherapy alone over about two years.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in organs, skin reactions, hormone gland problems (like thyroid issues), infusion reactions, fatigue, appetite changes, nausea. Chemotherapy drugs like Carboplatin and Paclitaxel can cause hair loss (alopecia), nerve damage (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ and bone marrow functions are normal.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have provided a tissue sample for PD-L1 analysis.
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I am 18 years old or older.
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My head or neck cancer has come back or spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Secondary outcome measures
Duration of Response of Participants Receiving Pembrolizumab + Chemotherapy
Overall Survival of Participants Receiving Pembrolizumab + Chemotherapy
Progression Free Survival of Participants Receiving Pembrolizumab + Chemotherapy
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and PaclitaxelExperimental Treatment3 Interventions
Participants in this group will receive 200 mg of pembrolizumab through an intravenous (IV) needle inserted into the arm plus chemotherapy with carboplatin (AUC 6) on day 1 and paclitaxel (200 mg) on day 1 of each 21-day cycle for two cycles.
Group II: Group 1: Participants Who Receive Pembrolizumab (Alone)Experimental Treatment1 Intervention
Participants in this group will receive pembrolizumab 200 mg through an intravenous (IV) needle inserted into the arm. Medications will be given on day 1 of each 21-day cycle for two cycles..
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,010 Previous Clinical Trials
733,898 Total Patients Enrolled
Ari Rosenberg, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
584 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received an organ or tissue transplant from another person.My organ and bone marrow functions are normal.I have cancer that has spread to my brain.I had radiation therapy less than 2 weeks ago or am still dealing with its side effects.I have had or currently have lung inflammation treated with steroids.I am fully active or restricted in physically strenuous activity but can do light work.My condition can be treated with the goal of curing it.I am HIV-positive and on combination antiretroviral therapy.I have an autoimmune or inflammatory disorder but don't need strong immune system drugs.I have an active Hepatitis B or C infection.I haven't had systemic therapy for cancer that returned or spread, except as part of treatment over 3 months ago.I have had an infection that needed treatment with medication.I am a woman who can have children and I have a negative pregnancy test.I have provided a tissue sample for PD-L1 analysis.I do not have any unmanaged ongoing illnesses.My head or neck cancer worsened within 3 months after treatment meant to cure it.I have not received a live vaccine in the last 28 days.I have been treated with anti-PD1 therapy before.My doctor expects I have less than 3 months to live or my disease is getting worse quickly.I have an active cancer that is not a non-melanoma skin cancer.I am 18 years old or older.I agree to use contraception if I'm sexually active with women who can become pregnant.My head or neck cancer has come back or spread.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel
- Group 2: Group 1: Participants Who Receive Pembrolizumab (Alone)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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 still openings available for potential participants in this research?
"Clinicaltrials.gov lists this medical trial as actively recruiting patients, with the start date of October 17th 2022 and most recent edits dated August 28th 2023."
Answered by AI
Has the FDA authorized Group 1: Participants Who Receive Pembrolizumab (Alone)?
"Taking into consideration the Phase 2 status of this medication, Group 1: Participants Who Receive Pembrolizumab (Alone) was granted a safety rating of 2. This is due to there being some data corroborating its security but with no proof of efficacy."
Answered by AI
What is the overall participation rate for this research study?
"Affirmative. Clinicaltrials.gov attests that this medical trial is actively enlisting participants, with the initial posting on October 17th 2022 and the most recent update occurring August 28th 2023. The study necessitates 30 people from a single site to take part."
Answered by AI
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