Using Afatinib to treat advanced skin cancer
Phase 2 Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
This study tests if Afatinib can help adults with advanced skin cancer that can't be treated with surgery or radiation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | immunotherapy, radiation, Afatinib |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT05070403 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Afatinib, a targeted therapy, in treating patients with advanced cutaneous squamous cell carcinoma (cSCC) that cannot be treated with surgery or radiation. Participants must be adults with measurable lesions and have previously received immunotherapy. The study aims to assess the drug's impact on disease progression and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced cSCC who have previously undergone immunotherapy.
Not a fit: Patients with early-stage cSCC or those who have not received prior immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cSCC.
How similar studies have performed: Other studies have shown promising results with targeted therapies in similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Zeynep Eroglu, MD — Moffitt Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.