A study of tolododekin alfa (also known as ANK-101) administered prior to surgery in kidney transplant participants that also have high-risk cutaneous squamous cell carcinoma (CSCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
IT administration of ANK-101 once every 3 weeks for 2 cycles, followed by surgical resection
Major Pathological Response (MPR) rate
The percentage of participants who have ≤ 10% viable cancer cells in the surgical pathology sample among all response evaluable participants.
Time frame: 3 months
Event Free Survival (EFS)
Time from the first dose of tolododekin alfa to date of event
Time frame: Up to 3 years
Relapse Free Survival (RFS)
Time from surgical resection to the earliest date of relapse or death from any cause.
Time frame: Up to 3 years
Pathological Complete Response (pCR)
The percentage of participants with complete absence of viable cancer cells in the surgical pathology sample among all response evaluable participants.
Time frame: 3 months
Best Overall Response Rate (BORR)
The percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 among all response evaluable participants.
Time frame: Up to 3 years
Overall Survival (OS)
The time from the administration of tolododekin alfa to death from any cause
Time frame: Up to 3 years
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