Phase 3 Study of Chemotherapy with or without Nivolumab for Metastatic Anal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04444921

Provider View

This clinical trial is testing whether adding the immunotherapy drug nivolumab to standard chemotherapy can improve treatment outcomes for patients with anal cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to compare the effectiveness of adding nivolumab, an immunotherapy drug, to the usual chemotherapy treatment of carboplatin and paclitaxel for anal cancer that has spread. Nivolumab may help the immune system attack cancer cells, while chemotherapy works to stop cancer cells from growing and spreading. Researchers want to find out if this combination is better than chemotherapy alone.

Description

The main goal of this study is to see if adding nivolumab to the chemotherapy drugs carboplatin and paclitaxel can help patients live longer without the cancer getting worse, compared to using chemotherapy alone. The study will also look at overall survival rates, how well the cancer responds to treatment, and the side effects of the treatments.

Participants will be randomly assigned to one of two groups:

  • Group A: Receives standard chemotherapy with paclitaxel and carboplatin every 28 days for up to 6 cycles.
  • Group B: Receives nivolumab along with paclitaxel and carboplatin every 28 days for up to 6 cycles, and nivolumab may continue for up to 2 years if tolerated.

After finishing the treatment, participants will have follow-up visits at 1 month, then every 3 months for 2 years to monitor their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Must have anal cancer that cannot be removed by surgery and has spread or come back.
  • Must be 18 years or older.
  • Must have a specific type of anal cancer confirmed by lab tests.
  • Must be in good general health, able to carry out normal activities or light work.
  • Must have measurable cancer that can be tracked by scans.
  • Can have had radiation therapy for pain relief, as long as the treated area is not the main cancer being measured.
  • Can have brain metastases if they are not causing symptoms and have been stable after treatment.
  • Must have certain blood counts and organ function within normal limits.
  • HIV-positive patients can participate if their condition is well-controlled.
  • Must agree to not receive live vaccines during the study.

Exclusion Criteria

  • Women must not be pregnant or breastfeeding.
  • Must not have had previous chemotherapy or investigational drugs for metastatic anal cancer.
  • Must not have had prior immunotherapy.
  • Must not have severe allergies to chemotherapy drugs or monoclonal antibodies.
  • Must not have active autoimmune diseases requiring treatment.
  • Must not be taking high doses of steroids or other immune-suppressing drugs.
  • Must not have had major surgery within 28 days before starting the study.
  • Must not have serious lung disease or active infections requiring IV antibiotics.
  • Must not have had another cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.

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