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PD-1 Inhibitor
Pembrolizumab + Radiotherapy for Recurrent Head and Neck Cancer (QUADSHOT Trial)
Phase 2
Recruiting
Led By Christina Henson, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Pathologically proven diagnosis of squamous cell carcinoma of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
QUADSHOT Trial Summary
This trial will test if a new radiotherapy treatment is safe for patients with recurrent head and neck cancer, and if it is effective in combination with pembrolizumab.
Who is the study for?
Adults with recurrent head and neck squamous cell carcinoma, who have evaluable lesions and whose cancer is not suitable for curative treatment. Participants must be at least six months past any prior radiation therapy, have adequate organ function, agree to use contraception if of reproductive potential, and not have used immunosuppressive medication recently.Check my eligibility
What is being tested?
'QUAD SHOT' radiotherapy combined with pembrolizumab is being tested for safety and effectiveness in treating patients with recurrent head and neck cancer. The study aims to see how well these treatments work together.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs, infusion-related reactions like fever or chills, fatigue, kidney problems from the contrast agent used during scans, skin reactions from radiotherapy, and potential complications related to existing health issues.
QUADSHOT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with squamous cell carcinoma in my head or neck.
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I can take care of myself and perform daily activities.
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My head or neck cancer has returned or spread and cannot be cured with surgery or more radiation, and it's been over 6 months since my last radiation treatment.
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My blood tests show enough neutrophils, platelets, and hemoglobin.
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My kidney function is good based on tests.
QUADSHOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health-Related Quality of Life Questionnaire
Tumor Response Rate
Secondary outcome measures
Duration of Response
Incidence of post treatment toxicities
Overall Survival
+1 moreQUADSHOT Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + QUADSHOT RadiotherapyExperimental Treatment1 Intervention
Combination Treatment
Pembrolizumab by IV once on day 1 of 21 day cycle, begin 7 days before the first round of QUAD SHOT radiotherapy.
QUAD SHOT radiotherapy twice a day for two days, begin 7 days after the first dose of pembrolizumab; repeat every 28 days for up to 3 rounds.
Maintenance Treatment
Pembrolizumab by IV once on day 1 of 21 day cycle
On day 21, if the medical oncologist feels that the patient may safely continue treatment, patient will receive a new 21 days cycle of treatment with pebrolizumab.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,587 Total Patients Enrolled
Christina Henson, MDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
3,500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an autoimmune disease in the last 2 years.I cannot have radiotherapy due to a genetic condition.My cancer is a non-squamous cell type of salivary gland cancer.I had skin cancer (not melanoma) treated and currently show no signs of it.I have had severe side effects from previous immunotherapy.I am 18 years old or older.I do not have any severe illnesses or conditions that are not under control.I had cancer before, treated over 5 years ago, with low risk of coming back.I have been diagnosed with squamous cell carcinoma in my head or neck.I've had radiation before and can't safely have it again due to the risk of severe side effects.My early-stage cancer was treated and shows no signs of disease.I have never been treated with PD-1 or PD-L1 inhibitors.I can take care of myself and perform daily activities.I agree to use birth control during the study.I have not had radiation on my cancer area in the last 6 months.My head or neck cancer has returned or spread and cannot be cured with surgery or more radiation, and it's been over 6 months since my last radiation treatment.I don't have severe side effects from past cancer treatments.My liver tests are within the normal range, or slightly above.My prostate cancer is low to intermediate risk and I am on active surveillance.I haven't taken strong immune-weakening medicines in the last 28 days, except for low-dose steroids or inhalers.I cannot have IV contrast due to poor kidney function or other reasons.I agree to use effective birth control or practice abstinence during and 90 days after the study.My blood tests show enough neutrophils, platelets, and hemoglobin.I have lung scarring or inflammation not caused by an infection.My kidney function is good based on tests.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + QUADSHOT Radiotherapy
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.
How many participants are currently involved in this research project?
"Affirmative, the clinicaltrials.gov webpage indicates that this medical research is currently recruiting volunteers. The trial began on December 23rd 2020 and was recently updated January 31st 2022 with a need for 23 patients from one centre."
Answered by AI
Are there any opportunities available to join this investigation?
"Per information available on clinicaltrials.gov, this medical trial is currently seeking new participants. It was initially listed on December 23rd 2020 and the most recent edit came through January 31st 2022."
Answered by AI
What have the results been from prior experiments involving Pebrolizumab + QUADSHOT Radiotherapy?
"Currently, there are 961 active clinical trials for Pebrolizumab + QUADSHOT Radiotherapy with 122 within Phase 3. These studies largely take place in Houston, TX but also span over 35 thousand locations worldwide."
Answered by AI
What health conditions can be addressed with the combination of Pebrolizumab and QUADSHOT Radiotherapy?
"Pebrolizumab + QUADSHOT Radiotherapy is usually employed to treat malignant neoplasms. It has additionally been used for the care of conditions such as advanced melanoma, microsatellite instability high, and cases where chemotherapy does not show any improvement."
Answered by AI
Has the federal government sanctioned the use of Pebrolizumab + QUADSHOT Radiotherapy?
"As a Phase 2 trial, pebrolizumab + QUADSHOT Radiotherapy has been largely proven safe, resulting in an estimated safety rating of two. Unfortunately, there is limited evidence to support its efficacy as of yet."
Answered by AI
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