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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

Must not have

Known Human Immunodeficiency Virus infection

Known Hepatitis B or C infection requiring ongoing treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I am currently being treated for Hepatitis B or C.

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My cancer has spread to my brain.

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I have received treatments other than first-line aPD1 monotherapy for my MCC.

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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.

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I do not have serious heart problems like recent stroke, heart attack, severe heart failure, or arrhythmias needing treatment.

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I take more than 10 mg of prednisone or similar medication daily.

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I have severe side effects from past cancer treatment that haven't gone away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression free survival

Secondary study objectives

overall response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (+20 minutes / -10 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

2017

Completed Phase 2

~2440

0 / 14Eligibility criteria met