Avelumab + Radiotherapy for Squamous Cell Carcinoma (UNSCARRed Trial)

Phase 2

Waitlist Available

Led By John Walker, Walker

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The following adequate organ function laboratory values must be met: Hematological: Absolute neutrophil count (ANC) >1.5 x109/L, Platelet count >100 x109/L, Hemoglobin >9 g/dL (may have been transfused); Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method); Hepatic: Total serum bilirubin <1.5x ULN, AST and ALT <2.5x ULN; Coagulation: International Normalized Ratio (INR) <1.5x ULN (unless patient is receiving anticoagulant therapy as long as prothrombin time (PT) or activated partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants), PTT <1.5x ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)

Patients with histologically confirmed, unresectable cuSCC, stage I-IV (M0)

Must not have

Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication

History of pneumonitis requiring treatment with steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying the effectiveness of radiation therapy combined with immunotherapy using the drug Avelumab to treat squamous cell carcinoma.

Who is the study for?

This trial is for adults with a type of skin cancer called unresectable cutaneous squamous cell carcinoma (cuSCC) that can't be removed by surgery. Participants must have measurable disease, be able to follow the study plan, and use effective birth control if they can have children. People with immune deficiencies, certain infections or recent vaccinations, severe allergies to monoclonal antibodies, or other serious health issues cannot join.

What is being tested?

The UNSCARRed Study is testing how well Avelumab combined with radiation therapy works against cuSCC. Patients will receive daily radiation treatments and Avelumab infusions every two weeks to see if this approach is more effective than previous treatments.

What are the potential side effects?

Possible side effects include typical reactions from immune therapies such as fatigue, infusion-related reactions like fever or chills, potential inflammation in various organs including the lungs (pneumonitis), and an increased risk of infection due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer cannot be removed by surgery and is stage I-IV but has not spread to distant organs.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Exclusion Criteria

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

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I have not had a recent serious heart condition or stroke.

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I have had lung inflammation treated with steroids.

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I have a history of active lung disease affecting the tissue and space around the air sacs.

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I am currently on medication for an infection.

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I have been diagnosed with an immune system disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and delegated study personnel will assess the patients for adverse events at baseline through to study completion per protocol (baseline, cycles 1-5 (each cycle is 14 days), and in follow up at 30 days, 90 days and every 12 weeks up to 2 years). for reporting.