Title
A Phase II Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer

Description
A single arm phase II study of pembrolizumab, carboplatin, paclitaxel, and radiation for the treatment of early-stage anal cancer. There are 2 treatments phases and then surveillance. The first treatment phase is the chemoradiation phase (Cycle 1-6, weekly cycles) which is followed by the maintenance phase (Cycle 7-14, 6 week cycles).

Objective
Primary Objective
-To estimate the clinical complete response rate (cCR) following weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of early-stage anal cancer.

Secondary Objectives
-To assess the safety and tolerability of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer.
-To assess the overall response rate of weekly carboplatin and paclitaxel in combination with pembrolizumab and radiation for the treatment of anal cancer
-To assess the tumor downstaging and disease-free survival of patients undergoing this treatment strategy.

Treatment Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Radiation: Radiation
Drug: Pembrolizumab

Key Eligibility For full study eligibility see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital