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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidneys are functioning well enough to clear waste.
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My skin cancer cannot be removed with surgery or has spread.
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I am HIV positive with a low viral load and on stable treatment.
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I can provide a suitable tissue sample for PD-L1 testing.
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I can take care of myself and am up and about more than half of my waking hours.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prolonging of progression free survival (PFS) on avelumab and cetuximab compared to avelumab alone
Secondary outcome measures
Clinical benefit rate (CBR)
Confirmed objective response rate (RR)
Incidence of adverse events
+2 moreTrial 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
2018
Completed Phase 2
~2450
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,578 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
Dan P. Zandberg, MDStudy ChairUniversity of Pittsburgh Medical Center Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 4 weeks.I have never had a severe reaction to cetuximab that stopped my treatment.I have never had serious heart failure.I haven't needed steroids for lung inflammation in the last 5 years.I have never had unstable chest pain.I have fully recovered from any major surgery before starting treatment.I have not had cetuximab for advanced skin cancer but may have had it for local treatment over 6 months ago.I have not had a heart attack in the last 6 months.I have not been treated with anti-PD-1 or anti-PD-L1 drugs.My skin cancer cannot be removed with surgery or has spread.I am HIV positive with a low viral load and on stable treatment.My kidneys are functioning well enough to clear waste.I haven't taken strong immune-weakening medicines in the last week, except for minor exceptions like inhalers or small doses of steroids.I haven't had radiation, chemotherapy, or experimental treatments in the last 2 weeks.I can provide a suitable tissue sample for PD-L1 testing.I do not have an active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.I don't have severe health issues that could worsen by joining this study.I have not had a stroke in the last 6 months.I don't have an autoimmune disease, except possibly type I diabetes, vitiligo, psoriasis, or thyroid issues not needing strong immune system drugs.I have never had an organ or stem cell transplant.I have no history of severe heart rhythm problems needing medication.I have not had an infection that needed treatment with medication.I have confirmed I am not pregnant within the last week.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (Avelumab)
- Group 2: Arm II (Avelumab, cetuximab)
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.
Are we still recruiting volunteers for this experiment?
"Yes, this research is currently enrolling participants. The trial was originally advertised on May 17th, 2019 and has since been updated on March 22nd, 2022 according to the website clinicaltrials.gov"
Answered by AI
For what purpose is Cetuximab commonly prescribed?
"While cetuximab is most often used as part of a radiation therapy treatment plan, it can also be effective in treating hnscc, and other conditions like pharmacotherapy and metastatic squamous cell carcinoma."
Answered by AI
Have there been other studies like this one before?
"As of now, there are 245 ongoing clinical trials for the use of Cetuximab. These studies span 1735 cities and 58 countries. The first official study was completed in 2005 and sponsored by Bristol-Myers Squibb. 154 patients were involved and it reached Phase 2 of drug approval stages. In the 16 years since then, an additional 412 have been conducted."
Answered by AI
Has the Federal Drug Administration sanctioned this medication?
"Cetuximab's safety is largely unknown as this medication is only in Phase 2 clinical trials. There is some data supporting its safety, but none yet affirming its efficacy."
Answered by AI
Could you please tell me how many facilities are administering this trial?
"There are 100 total sites for this trial, including Rocky Mountain Cancer Centers-Littleton in Littleton and Ochsner Medical Center Kenner in Kenner."
Answered by AI
Are there other examples of Cetuximab being used in a medical setting?
"Cetuximab was first trialled in 2005 at the Mamie McFaddin Ward Cancer Center. In total, there have been 412 completed clinical trials and 245 studies are still ongoing. The majority of these current studies take place in Englewood, Colorado."
Answered by AI
How many people can sign up for this clinical trial?
"That is correct. The clinicaltrials.gov website says that the research team is actively recruiting patients for this trial. This particular study was first posted on May 17th, 2019 and was last updated on March 22nd, 2022. They are looking to enroll 59 individuals total at 100 different research sites."
Answered by AI
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