RecruitingPhase 2NCT06493019

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

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


Sponsor

Dustin Deming

Enrollment

23 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding the immunotherapy drug pembrolizumab to the standard chemoradiation treatment for early-stage anal cancer can improve cure rates while staying safe. **You may be eligible if...** - You are 18 or older - You have been diagnosed with early-stage squamous cell carcinoma of the anus (Stage I through IIIA) - You are in generally good health and able to carry out daily activities (ECOG 0–1) - You have not received prior treatment for this cancer - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have Stage IIIB or Stage IV (very advanced) anal cancer - You have previously received chemotherapy or radiation for anal cancer - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding - You have had a major surgery in the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Chemoradiation Pembrolizumab 200mg IV

DRUGPaclitaxel

Paclitaxel 50 mg/m\^2 IV

DRUGCarboplatin

Carboplatin AUC 2 IV

RADIATIONRadiation

Delivered as per institutional standards

DRUGPembrolizumab

Maintenance Pembrolizumab 400mg IV


Locations(4)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06493019


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