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Monoclonal Antibodies
Avelumab + Radiation Therapy for Merkel Cell Carcinoma
Phase 2
Recruiting
Led By Christoper Barker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
Normal organ and marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights
Study Summary
This trial will test whether combining immunotherapy with radiation therapy can effectively treat Merkel cell carcinoma.
Who is the study for?
This trial is for adults with advanced Merkel cell carcinoma (MCC) that has worsened after first-line treatment and can't be surgically removed. Participants must have had prior therapy with aPD1 monotherapy, adequate organ function, and all MCC sites treatable by radiation. Exclusions include other cancer treatments, brain metastases, certain infections or immunosuppression conditions, recent vaccinations, severe allergies to avelumab, or significant heart disease.Check my eligibility
What is being tested?
The study is examining the effectiveness of combining comprehensive ablative radiation therapy (CART) with the immunotherapy drug avelumab in treating MCC. Researchers aim to determine if CART enhances the effects of avelumab in patients whose disease progressed after initial treatment.See study design
What are the potential side effects?
Avelumab may cause immune-related side effects such as inflammation in various organs including skin reactions and thyroid issues; infusion reactions like fever or chills; fatigue; nausea; and potential increased risk of infection. Radiation therapy might lead to skin irritation at the treated site, fatigue, mild swelling or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys work well enough (creatinine clearance ≥ 30 mL/min).
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My organs and bone marrow are functioning normally.
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My liver function tests are within the required range.
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My Merkel cell carcinoma is at stage III or IV and cannot be surgically removed.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression free survival
Secondary outcome measures
overall response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avelumab and Radiation TherapyExperimental Treatment2 Interventions
Will receive avelumab at the FDA approved dose and schedule of 800 mg IV over 60 minutes every 2 weeks (+/- 3 days) until treatment intolerance or disease progression occurs or 2 years of study therapy have been administered; standard of care Avelumab therapy after 2 years is permitted. Comprehensive Ablative Radiation Therapy (CART) will be initiated between the first and second dose of Avelumab. Comprehensive ablative radiation therapy will be given according to guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,353 Total Patients Enrolled
EMD SeronoIndustry Sponsor
143 Previous Clinical Trials
27,183 Total Patients Enrolled
Christoper Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.Your blood counts need to be within certain ranges: lymphocytes above 800/mm^3, neutrophils above 1500/mm^3, platelets above 75,000/mm^3, white blood cells above 3000/mm^3, and hemoglobin above 9 g/dL.I have received treatments other than first-line aPD1 monotherapy for my MCC.I am currently being treated for Hepatitis B or C.My cancer has spread to my brain.My kidneys work well enough (creatinine clearance ≥ 30 mL/min).My organs and bone marrow are functioning normally.My liver function tests are within the required range.I got worse on aPD1 therapy but it's been over 6 weeks since I started.You have an autoimmune disease that could worsen with this treatment, a history of organ transplant, an ongoing infection that needs medicine to treat it, or a serious mental health concern. You also have certain types of cancer or other health issues that could affect the study results.I do not have serious heart problems like recent stroke, heart attack, severe heart failure, or arrhythmias needing treatment.My previous radiation therapy prevents me from safely receiving more targeted radiation.I have not had any live vaccines within 4 weeks before starting avelumab, but may have had inactivated ones.I take more than 10 mg of prednisone or similar medication daily.I have severe side effects from past cancer treatment that haven't gone away.My cancer progressed 10 weeks after starting aPD1 therapy without major health decline.You have had a very bad allergic reaction to avelumab in the past.My Merkel cell carcinoma is at stage III or IV and cannot be surgically removed.All my Merkel cell carcinoma sites can be treated with radiation.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab and Radiation Therapy
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.
Could you explain what risks are associated with Comprehensive Ablative Radiation Therapy?
"While Phase 2 trials lack the data to support efficacy, there is some evidence that Comprehensive Ablative Radiation Therapy is safe. Thus, we give it a score of 2."
Answered by AI
Are there any slots left for volunteers in this experiment?
"This is accurate. Based on the information available from clinicaltrials.gov, this study posted on 3/8/2021 and last updated 9/21/2022 is looking for 18 participants to be enrolled at 7 different locations."
Answered by AI
What percentage of hospitals are participating in this research?
"7 different locations, including ones in Basking Ridge, Commack and New york, are currently enrolling patients for this study. To reduce the amount of travelling required, please select the closest location to you."
Answered by AI
How many men and women are enrolled in this research project?
"The clinical trial is currently ongoing, as reflected by the data on clinicaltrials.gov. It began on 3/8/2021 and was updated most recently on 9/21/2022. The study needs 18 participants who can be found at 7 sites."
Answered by AI
Have there been other tests like this one in the past?
"There have been a total of 47 clinical trials for Comprehensive Ablative Radiation Therapy since 2014. The most recent study is still active, having begun in 2020. A total of 116 studies are currently underway across 1024 cities and 52 countries."
Answered by AI
What other medical studies have there been on Comprehensive Ablative Radiation Therapy?
"At the moment, there are a total of 116 ongoing clinical trials for Comprehensive Ablative Radiation Therapy (CAR-T). 10 of these live trials are currently in Phase 3. The majority of studies related to CAR-T are based in Barcelona and South dakota; however, there are 3692 locations worldwide where these trials are taking place."
Answered by AI
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