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Alkylating agents
Pembrolizumab + Cisplatin + IMRT for Head and Neck Cancer
Phase 2
Waitlist Available
Led By David Clump, MD
Research Sponsored by Dan Zandberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and/or nodal sites is permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing two different ways of using pembrolizumab to treat patients with head and neck cancer. The first is to give it along with the usual cisplatin and radiation therapy. The second is to give it after the patient has completed cisplatin and radiation therapy.
Who is the study for?
Adults with specific types of head and neck cancer, including oral cavity or larynx cancers, who haven't had chemotherapy or radiation for it. They must be in good physical condition (ECOG 0-1), not pregnant, and willing to use contraception. Excluded are those with severe allergies to trial drugs' components, certain heart conditions, recent major surgery, active hepatitis B/C or HIV infection.Check my eligibility
What is being tested?
The study is testing the effectiveness of pembrolizumab when given during standard cisplatin-radiation treatment versus after it for head and neck cancer. Pembrolizumab is an immune therapy drug approved for other cancers but not yet for head and neck cancer.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects like inflammation in organs, skin reactions, hormone gland problems (like thyroid issues), infusion reactions; Cisplatin may cause nausea, kidney damage; IMRT might lead to skin irritation at the treated site.
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 not had surgery to cure my Stage III, IVa, or IVb disease, but a biopsy is okay.
Select...
I have not had radiation therapy above my collarbone.
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I am fully active or can carry out light work.
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I have not had chemotherapy, targeted therapy, or radiation for head and neck cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year failure rate
1-year progression-free survival
Acute Toxicity Rate
Secondary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)
Side 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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisp/radiation and given every 3 weeks
Group II: Arm 1Experimental Treatment3 Interventions
Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplating and radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
IMRT
2003
Completed Phase 3
~1570
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,638 Total Patients Enrolled
Dan ZandbergLead Sponsor
5 Previous Clinical Trials
208 Total Patients Enrolled
David A. Clump, MD, PhDLead Sponsor
9 Previous Clinical Trials
276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have not had surgery to cure my Stage III, IVa, or IVb disease, but a biopsy is okay.I am not pregnant or breastfeeding.I have not had radiation therapy above my collarbone.I am fully active or can carry out light work.I have not taken steroids or immunosuppressants in the last 7 days.I haven't had monoclonal antibody treatment in the last 4 weeks or still have side effects from it.I have an autoimmune disease that needed treatment in the last 3 months.I have a history of HIV or active Hepatitis B or C.I have not received a live vaccine in the last 30 days.I have been treated with drugs that target the immune system.I do not have any health or mental conditions that could affect the study.I have not had major surgery in the last 6 weeks.I haven't taken antibiotics or antifungals for an infection in the last 7 days.I have squamous cell carcinoma in my head or neck without cancer spread to distant parts.My condition is considered high or intermediate risk.I had a tonsillectomy, but my cancer can still be measured in my lymph nodes.I had a second head/neck cancer more than 2 years after the first, treated with surgery only, and it hasn't come back.My organs are functioning well.My cancer has not spread to distant parts of my body, including the brain.I have a serious lung condition.I have moderate to severe numbness, tingling, or pain in my hands or feet.My cancer originates in the nasopharynx.I had chemotherapy or radiation for another cancer type, but it was over 2 years ago.I have not had another type of cancer in the last 2 years.I have serious heart problems.I have not had chemotherapy, targeted therapy, or radiation for head and neck cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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 FDA approved Pembrolizumab for clinical use?
"Even though there is no clinical data that supports its efficacy, pembrolizumab has been awarded a safety ranking of 2 because some evidence exists to suggest it is safe."
Answered by AI
Could you provide an overview of past research related to Pembrolizumab?
"Currently, 1555 studies are actively investigating pembrolizumab with 355 trials in the third stage of development. The majority of these tests are hosted by medical centres located in Shanghai; however, there are 70,004 different sites that offer clinical trials for this medication."
Answered by AI
What is the participant threshold for this medical experiment?
"Unfortunately, this medical study is not currently accepting any new patients. The initial posting date was May 31st 2016 and the last edit to the page occurred on September 15th 2022. Alternately, prospective participants can consider one of 1068 trials for head neoplasms or 1555 studies regarding Pembrolizumab that are still open to enrolment."
Answered by AI
Are individuals being accepted for enrolment in this research project?
"This research project, which was initially uploaded to clinicaltrials.gov on May 31st 2016 and edited lastly on September 15th 2022, is not currently recruiting applicants. However, there are over 2600 other medical trials presently taking partakers./"
Answered by AI
In what circumstances is Pembrolizumab routinely administered?
"Pembrolizumab has been proven effective in treating malignant neoplasms, cases of unresectable melanoma, and microsatellite instability high."
Answered by AI
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