RECRUITING

Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to find out if Afatinib can help treat participants with advanced cSCC.

Official Title

Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

Quick Facts

Study Start:2021-10-01

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05070403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years at the time of informed consent * ECOG performance status ≤2 * Adequate bone marrow, organ function and laboratory parameters: * ANC ≥ 1.0 × 109/L; * Hemoglobin ≥ 8 g/dL; * Platelets ≥ 75 × 109/L; * AST and ALT ≤5 × ULN * Calculated creatinine clearance \> 15mL/min by Cockroft-Gault formula * Histologic diagnosis of invasive cutaneous squamous cell carcinoma, that is deemed not appropriate for further surgical intervention and/or radiation therapy. Participants may have either locally advanced or metastatic disease. * At least 1 measurable lesion - either per RECIST 1.1 criteria, or for patients with externally visible cuSCC lesion(s) not measurable on imaging, at least one lesion ≥1 cm in longer diameter, amenable to digital photography with bi-dimensional measurements * Participants must have received prior immunotherapy with an anti-PD-1/PD-L1 antibody, if participant was deemed eligible (i.e., was not immunosuppressed or a transplant receipt, etc) * Immunosuppressed participant including those with concurrent autoimmune diseases and solid organ transplant recipients are eligible * Prior to first dose of study treatment, participant must be at least 2 weeks from any prior systemic therapy, major surgery or radiation * Able to undergo a pre-treatment and on-treatment tumor biopsy * Female participants of childbearing potential must have a negative serum or urine β-HCG test result. Female participants of childbearing potential and male participants must agree to use methods of contraception that are highly effective. * Participants with brain metastases are permitted assuming that the brain metastases have been adequately treated with prior surgery or radiation.	* In participants with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment will be excluded. * Untreated, uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable or require corticosteroids, * Participants with mixed histologies (eg, sarcomatoid, adenosquamous) will generally not be eligible, unless the predominant histology is invasive cuSCC. * Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization. Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization. * Pregnancy or breast feeding.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years at the time of informed consent
* ECOG performance status ≤2
* Adequate bone marrow, organ function and laboratory parameters:
* ANC ≥ 1.0 × 109/L;
* Hemoglobin ≥ 8 g/dL;
* Platelets ≥ 75 × 109/L;
* AST and ALT ≤5 × ULN
* Calculated creatinine clearance \> 15mL/min by Cockroft-Gault formula
* Histologic diagnosis of invasive cutaneous squamous cell carcinoma, that is deemed not appropriate for further surgical intervention and/or radiation therapy. Participants may have either locally advanced or metastatic disease.
* At least 1 measurable lesion - either per RECIST 1.1 criteria, or for patients with externally visible cuSCC lesion(s) not measurable on imaging, at least one lesion ≥1 cm in longer diameter, amenable to digital photography with bi-dimensional measurements
* Participants must have received prior immunotherapy with an anti-PD-1/PD-L1 antibody, if participant was deemed eligible (i.e., was not immunosuppressed or a transplant receipt, etc)
* Immunosuppressed participant including those with concurrent autoimmune diseases and solid organ transplant recipients are eligible
* Prior to first dose of study treatment, participant must be at least 2 weeks from any prior systemic therapy, major surgery or radiation
* Able to undergo a pre-treatment and on-treatment tumor biopsy
* Female participants of childbearing potential must have a negative serum or urine β-HCG test result. Female participants of childbearing potential and male participants must agree to use methods of contraception that are highly effective.
* Participants with brain metastases are permitted assuming that the brain metastases have been adequately treated with prior surgery or radiation.

* In participants with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment will be excluded.
* Untreated, uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable or require corticosteroids,
* Participants with mixed histologies (eg, sarcomatoid, adenosquamous) will generally not be eligible, unless the predominant histology is invasive cuSCC.
* Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization. Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization.
* Pregnancy or breast feeding.

Contacts and Locations

Study Contact

Ashley Paneto-Matos

CONTACT

813-745-3922

Ashley.Paneto-Matos@moffitt.org

Principal Investigator

Zeynep Eroglu, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Zeynep Eroglu, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01

Study Completion Date2028-07

Study Record Updates

Study Start Date2021-10-01

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

Skin Cancer

Additional Relevant MeSH Terms

Squamous Cell Carcinoma