Avelumab With or Without Cetuximab in Treating Patients With Advanced Skin Squamous Cell Cancer

  • End date
    Dec 19, 2023
  • participants needed
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 19 November 2020
Dan P. Zandberg, MD
Primary Contact
Epic Care Cyberknife Center (0.7 mi away) Contact
+338 other location
platelet count
monoclonal antibodies
serum pregnancy test
measurable disease
investigational drug
neutrophil count
tumor cells
solid tumors
metastatic cutaneous squamous cell carcinoma


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.



I. To evaluate whether treatment with avelumab plus cetuximab prolongs progression free survival (PFS) compared to avelumab alone.


I. To evaluate the confirmed objective response rate of each treatment arm. II. To evaluate the clinical benefit rate of each treatment arm. III. To evaluate the PFS of cetuximab plus avelumab in patients that have progressed on single agent avelumab.

IV. To evaluate the overall survival (OS) for each treatment arm. V. To evaluate toxicity across treatment arms of avelumab plus cetuximab and avelumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive avelumab intravenously (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.

ARM II: 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.

After completion of study treatment, patients are followed up every 3 months until disease progression, then every 6 months for up to 2 years.

Treatment Cetuximab, Avelumab
Clinical Study IdentifierNCT03944941
SponsorAlliance for Clinical Trials in Oncology
Last Modified on19 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Skin Squamous Cell Carcinoma or Metastatic Skin Cancer?
Do you have any of these conditions: Metastatic Skin Cancer or squamous cell skin cancer or Cutaneous Squamous Cell Carcinoma or skin metastases or Skin Squamous Cell Carcinoma?
Do you have any of these conditions: skin metastases or Metastatic Skin Cancer or Skin Squamous Cell Carcinoma or squamous cell skin cancer or Cutaneous Squamous Cell Carcinoma?
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
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 therapy (HAART) the patient must have been so for > 4 weeks
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Calculated creatinine clearance >= 30 mL/min
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferases (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

Exclusion Criteria

Patients who received prior treatment with cetuximab as palliative treatment for advanced cutaneous squamous cell carcinoma (cSCC) are excluded. Patients that received cetuximab based chemoradiation (either definitive or adjuvant) as prior treatment for locally advanced disease are eligible as long as the last dosage was given >= 6 months prior to registration
Patients who received prior cetuximab and had a severe infusion reaction requiring discontinuation of cetuximab are excluded
Patients treated with prior anti-PD-1 or anti-PD-L1 monoclonal antibodies (mAbs) are excluded
Patients cannot have received treatment with radiation or chemotherapy including another investigational agent within 2 weeks of registration. Other than as stated above for cetuximab there are no limits on the number of lines of other therapies given for advanced cSCC
Patients with a "currently active" second malignancy will be excluded with the exception of other non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for 3 years
No history of the following
Autoimmune disease (including inflammatory bowel disease) with the exception of patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
Non-infectious pneumonitis that required steroids within 5 years
Organ transplant including prior stem cell transplant
Receipt of a live vaccine =< 4 weeks
Cerebral vascular accident/stroke within 6 months of enrollment
Myocardial infarction within 6 months of enrollment
Active unstable angina
Congestive heart failure (>= New York Heart Association Classification class II)
Serious cardiac arrhythmia requiring medication. Whether an arrhythmia is considered "serious" is at the discretion of the investigator
Active infection requiring systemic treatment
Use of immunosuppressive medication =< 7 days of registration, EXCEPT for the
Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
Other severe acute or chronic medical conditions including but not limited to immune colitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
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