A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
•Patients must have histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal (anal margin) squamous cell carcinoma; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology
•Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•Human immunodeficiency virus (HIV)+ patients with CD4 > 200 and serum HIV viral load of < 200 copies/mm^3 are permitted
•For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration
•Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded
•Women of child-bearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 5 months after the last dose of nivolumab; sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 7 months after the last dose of nivolumab
•Women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration
•Pregnant women are excluded from this study; breastfeeding should be discontinued
•Patients will be excluded if they have a T1, T2N0 or M1 cancer
•Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus
•Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
•Any surgery must have been completed >= 4 weeks prior to starting study treatment
Alison Conlin, M.D.
NCI (National Cancer Institute)
The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.