Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.

Official Title

A Randomized Phase III Study of Immune Checkpoint Inhibition With Chemotherapy in Treatment-Naive Metastatic Anal Cancer Patients

Details

Keywords

Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Metastatic Anal Squamous Cell Carcinoma, Recurrent Anal Squamous Cell Carcinoma, Stage III Anal Cancer AJCC v8, Stage IV Anal Cancer AJCC v8, Unresectable Anal Squamous Cell Carcinoma, Carcinoma, Squamous Cell Carcinoma, Anus Neoplasms, Paclitaxel, Carboplatin, Nivolumab, Albumin-Bound Paclitaxel, carboplatin, paclitaxel, carboplatin, paclitaxel, nivolumab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04444921
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 205 study participants
Last Updated