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Checkpoint Inhibitor
Radiotherapy + Immunotherapy for Head and Neck Cancer
Phase 2
Recruiting
Led By Mercedes Porosnicu, MD
Research Sponsored by Wake Forest University Health Sciences
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 at 6 months and 1 year post treatment
Awards & highlights
Study Summary
This trial will test a new combination of quad-shot palliative radiotherapy with immunotherapy to treat advanced/recurrent/metastatic head and neck cancer.
Who is the study for?
Adults with advanced, recurrent, or metastatic head and neck squamous cell carcinoma suitable for palliative radiotherapy. Participants must be over 18, have a performance status of 0-2 (able to carry out daily activities), agree to use contraception if applicable, and have adequate organ function. Exclusions include pregnancy, prior significant immunotherapy reactions, certain heart conditions, uncontrolled illnesses like hypertension or infections.Check my eligibility
What is being tested?
The trial is testing the combination of quad-shot palliative radiotherapy with Pembrolizumab (an immunotherapy drug) in patients with advanced head and neck cancer. It's a single-arm study where all participants receive both treatments to assess effectiveness and side effects.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that can affect organs like the lungs (pneumonitis), infusion-related symptoms such as fever or chills, fatigue, digestive issues including diarrhea or colitis from inflammation of the bowel lining.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months and 1 year post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months and 1 year post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response
Secondary outcome measures
Duration of Response at the Target Lesions - Mean Measurement
Duration of Response at the Target Lesions - Median Measurement
Incidences of Adverse Events
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Quad-shot palliative radiotherapy and ImmunotherapyExperimental Treatment2 Interventions
Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,711 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,926,014 Total Patients Enrolled
Mercedes Porosnicu, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.I haven't had autoimmune diseases, except for vitiligo, Grave's disease, or psoriasis without needing systemic treatment, in the last 2 years.I am willing to give blood and saliva samples for research.I haven't taken strong immune system drugs in the last month, except for small doses or for allergies.I do not have any health conditions that prevent me from receiving radiotherapy.I am allergic to ingredients in pembrolizumab.I agree to use effective birth control or abstain from sex during the study.I can understand and am willing to sign the consent form.I have seizures that are not controlled by medication.I have received an organ from another person.I have or had Crohn's disease or ulcerative colitis.I haven't had radiation therapy in the target area within the last 30 days.I've had radiotherapy to my head or neck that makes more unsafe.I haven't had any cancer treatment except for palliative radiotherapy in the last 30 days.I don't have severe side effects from past cancer treatments that could worsen.I have an active case of tuberculosis.I have not received a live vaccine within 30 days before joining the study or before getting pembrolizumab.I do not have any serious ongoing illnesses that my doctor hasn't been able to get under control.My cancer is a spreading head and neck squamous cell carcinoma.My cancer in the head or neck can be treated with short-term radiation.I am 18 years old or older.I can take care of myself and perform daily activities.My blood counts and liver/kidney functions are within normal ranges.My head or neck cancer cannot be cured with surgery or radiation.I have a history of primary immunodeficiency.My cancer is an advanced or recurrent head and neck squamous cell carcinoma.I have been treated with a PD1 or PD-L1 inhibitor before.I have experienced severe side effects from previous immunotherapy.My head or neck cancer has come back and cannot be cured with surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Quad-shot palliative radiotherapy and Immunotherapy
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.
What are some of the most popular indications for Pembrolizumab?
"Pembrolizumab is an immunotherapy medication that can be used to fight cancer. It has also been shown to effectively target unresectable melanoma, microsatellite instability high, and chemotherapy-resistant conditions."
Answered by AI
What is the current FDA stance on Pembrolizumab?
"Pembrolizumab (immunotherapy) is currently in Phase 2 of clinical trials, so there is some data supporting its safety. However, since this medication is still in testing, there is no evidence yet indicating that it is effective."
Answered by AI
How many people have been asked to participate in this experiment?
"That is correct. The clinical trial in question, which was posted on February 25th 2021 and updated October 3rd 2022, is still recruiting the 15 participants it needs from a single site."
Answered by AI
What other scientific investigations have been executed that concern Pembrolizumab?
"Pembrolizumab (immunotherapy) is being trialed in 1000 different active studies, with 122 of those trials in the third phase. Most of these clinical trials are based out of Houston, Texas; however, there are 36034 total locations running Pembrolizumab (immunotherapy) trials."
Answered by AI
Are there any available slots for patients who want to enroll in this clinical trial?
"Yes. The clinical trial information available on clinicaltrials.gov indicates that this study is currently looking for participants. This particular trial was originally posted on February 25th, 2021 and was most recently edited on October 3rd, 2022. They are specifically looking for 15 individuals at 1 site."
Answered by AI
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