Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

Conditions

• Anal Basaloid Carcinoma
• Anal Canal Cloacogenic Carcinoma
• Anal Margin Squamous Cell Carcinoma
• Stage IIB Anal Cancer AJCC v8
• Stage III Anal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Colonoscopy — PROCEDURE
  Undergo colonoscopy
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Digital Rectal Examination — PROCEDURE
  Undergo digital rectal examination
• High Resolution Anoscopy — PROCEDURE
  Undergo anoscopy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Patient Observation — OTHER
  Undergo observation
• Proctoscopy — PROCEDURE
  Undergo proctoscopy
• Sigmoidoscopy — PROCEDURE
  Undergo sigmoidoscopy
• X-Ray Imaging — PROCEDURE
  Undergo chest x-ray

Study Details

This phase III trial investigates how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. 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.

Key Dates

Start date

Jul 5, 2018

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

344 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (nivolumab)
  Patients receive nivolumab while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.
• Other: Arm B (clinical observation)
  Patients undergo observation while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Disease free survival [ Time Frame: Up to 5 years ]

Locations (888)

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