Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

Conditions

• Anal Canal Squamous Cell Carcinoma
• Metastatic Anal Canal Carcinoma
• Stage IV Anal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Ipilimumab — BIOLOGICAL
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date

May 13, 2015

Status verified

Mar 2026

Primary completion

Feb 15, 2025

Completion

Mar 20, 2027

Study Design

Enrollment

143 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A (nivolumab)
  Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
• Experimental: Part B Arm I (nivolumab)
  Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
• Experimental: Part B Arm II (nivolumab, ipilimumab)
  Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Primary Outcome Measure

Overall Response Rate: Number of Participants With Response (Part A) [ Time Frame: Up to 2 years ]

Locations (55)

Related coverage on Hipa.ai

• Nivolumab Monotherapy and Combination Show Activity in Anal Canal Cancer
  Nivolumab · Apr 22, 2026 · ClinicalTrials.gov

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