drugset / Trial / NCT04444921

EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients

NCT04444921 ↗

Phase 3 Active not recruiting 205 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-11-17
Primary completion
2027-03-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule — Intravenous