← Back to Search

Monoclonal Antibodies

Avelumab +/− Cetuximab for Skin Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance >= 30 mL/min

Biopsy-proven advanced cutaneous squamous cell carcinoma. Advanced disease is defined as either metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma not amenable to curative surgical resection, or the patient declines surgical resection

Must not have

No history of congestive heart failure (>= New York Heart Association Classification class II)

Patients who received prior cetuximab and had a severe infusion reaction requiring discontinuation of cetuximab are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well immunotherapy works in treating patients with skin cancer that has spread.

Who is the study for?

This trial is for adults with advanced skin squamous cell cancer that's spread or can't be removed by surgery. Participants need enough tissue for PD-L1 testing, measurable disease, normal organ function tests, and no recent major surgeries. They must not have had certain past treatments like cetuximab (unless it was over 6 months ago) or anti-PD-1/L1 drugs, autoimmune diseases needing immunosuppression, serious infections or heart issues.

What is being tested?

The study is examining the effectiveness of avelumab alone versus combined with cetuximab in treating advanced skin squamous cell cancer. Avelumab and cetuximab are both monoclonal antibodies which may boost the immune system to fight cancer cells and prevent their growth.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions from receiving the drug through a vein, fatigue, liver enzyme changes suggesting liver damage, low blood counts increasing infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidneys are functioning well enough to clear waste.

Select...

My skin cancer cannot be removed with surgery or has spread.

Select...

I am HIV positive with a low viral load and on stable treatment.

Select...

I can provide a suitable tissue sample for PD-L1 testing.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

Select...

I have never had serious heart failure.

Select...

I have never had a severe reaction to cetuximab that stopped my treatment.

Select...

I haven't needed steroids for lung inflammation in the last 5 years.

Select...

I have never had unstable chest pain.

Select...

I have not been treated with anti-PD-1 or anti-PD-L1 drugs.

Select...

I have never had an organ or stem cell transplant.

Select...

I have no history of severe heart rhythm problems needing medication.

Select...

I have not had an infection that needed treatment with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Prolonging of progression free survival (PFS) on avelumab and cetuximab compared to avelumab alone

Secondary study objectives

Clinical benefit rate (CBR)

Confirmed objective response rate (RR)

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (Avelumab, cetuximab)Experimental Treatment2 Interventions

Patients receive cetuximab IV over 1-2 hours on days 1, 8,15, and 22 and avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles for cetuximab and 24 cycles for avelumab in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (Avelumab)Active Control1 Intervention

Patients receive avelumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with avelumab failure will crossover to Arm II.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

Cetuximab

2011

Completed Phase 3

~2480