Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT06041802
Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histologically confirmed cSCC by the investigator as the primary site of malignancy
* R/M cSCC cohort only: Has metastatic disease, defined as disseminated disease distant to the initial/primary site of diagnosis, and/or has locally recurrent disease that has been previously treated (with either surgery or radiotherapy) and is not curable by either surgery or radiotherapy
* LA unresectable cSCC cohort only: Is ineligible for surgical resection
* LA unresectable cSCC cohort only: Has received prior radiation therapy (RT) to index site or has been deemed to be not eligible for RT
* LA unresectable cSCC cohort only: Has received prior systemic therapy for curative intent are eligible regardless of regimen
* Has a life expectancy of greater than 3 months
* Must provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Exclusion Criteria:
* Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
* Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study
* Has received prior systemic anticancer therapy including investigation agents within 4 weeks before allocation
* Has not adequately recovered from major surgery or has ongoing surgical complications
* Received prior radiotherapy within 2 weeks of study intervention, or had radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has an ongoing active infection requiring systemic therapy
* Has a history of human immunodeficiency virus (HIV) infection
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has history of allogenic tissue/organ transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06041802
Study Brief:
Protocol Section:
NCT06041802