Nivolumab for Anal Cancer
Recruiting at 1015 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Research Team
LR
Lakshmi Rajdev
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults with high-risk stage II-IIIB anal cancer who have not had prior immune checkpoint inhibitor therapy, no recent transplants, autoimmune disease, or other cancers. HIV+ patients are eligible if well-managed. Participants must meet specific blood count and organ function criteria and agree to contraception.Inclusion Criteria
Your blood test taken within 2 weeks before the study shows that your ANC level is above 1500/mm^3.
Absolute neutrophil count (ANC) level of > 1500/mm^3 (within 2 weeks prior to registration)
Your liver enzymes (AST and ALT) should not be more than 2.5 times the normal level. This will be checked within 2 weeks before you enroll in the study.
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Exclusion Criteria
I am not taking any other cancer treatments or experimental drugs with the study drugs.
I have had chemoradiotherapy for anal cancer before.
I have lung disease that could affect my treatment.
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Treatment Details
Interventions
- Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe trial is testing the effectiveness of nivolumab as an immunotherapy after standard treatment for anal cancer. It aims to see if nivolumab can help the immune system attack cancer cells better and prevent the disease from spreading.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B (clinical observation)Experimental Treatment10 Interventions
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.
Group II: Arm A (nivolumab)Experimental Treatment11 Interventions
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Trials
14,080
Recruited
41,180,000+
Canadian Cancer Trials Group
Collaborator
Trials
135
Recruited
70,300+