Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer (NCT03944941) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer
United States60 participantsStarted 2019-06-17
Plain-language summary
This phase II trial studies how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION ELIGIBILITY CRITERIA
* Provide adequate tissue for PD-L1 testing
\* Fresh tissue or archival tissue can be used. Sample must be at least core needle biopsy. Fine needle aspiration is not adequate. This specimen submission is mandatory prior to registration as results will be used for stratification
* REGISTRATION ELIGIBILITY CRITERIA
* • 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
* The patient must have at least one lesion that is measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
* This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* If human immunodeficiency virus (HIV) positive the HIV viral load must be \< 200 copies/mL and CD4 count \> 200. If an HIV positive patient is on highly active antiretroviral t…
What they're measuring
1
Prolonging of progression free survival (PFS) on avelumab and cetuximab compared to avelumab alone
Timeframe: Time between registration and evidence of disease progression or death, assessed up to 2 years post treatment