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Protocol No. EA2165

Principal Investigator Deming, Dustin

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase III Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

Objective The purpose of this study is to find if adding the study drug, nivolumab (also known as OPDIVO®), after standard chemotherapy {(mitomycin-C and 5-fluorouracil (5-FU) or capecitabine) or 5-FU and cisplatin} and radiation will prevent the anal cancer from returning. Nivolumab is a drug that may turn on the body s immune system to attack any cancer cells that may remain after chemotherapy and radiation. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for anal cancer. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.

Treatment You receive standard of care chemotherapy/radiation, then you will be randomized to either
  • Group 1 will get the study drug, nivolumab. Nivolumab is administered by an intravenous (IV) infusion over 30 minutes once every four weeks. Treatment will continue for a maximum of 6 months or 6 doses of nivolumab or until you have side effects, your cancer returns, or you decide to stop
    OR
  • Group 2 will be monitored with standard follow up treatment

  • Description Phase II Study of Nivolumab after Combined Modality Therapy in High Risk Anal Cancer

    Key Eligibility Step 1 and Step 2:
  • Age greater than or equal to 18 years
  • Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th edition. This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
  • For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer
  • Patients must have ECOG performance status of 0-2
  • Adequate hematologic and hepatic function as described by the protocol
  • Patients known to be Human immunodeficiency virus (HIV)+ are permitted. Patients with CD4 greater than 200 and Serum HIV viral load of less than 200 copies/mm3 are eligibile, if addition to: PPD negative, No history of AIDS-related complications within past year other than a history of low CD4+ T-cell count, Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer, Participants MUST receive appropriate care and treatment for HIV infection, and Patient must have less than or equal to grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative
  • For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration(Step 1 only)
  • 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
  • Women can not be pregnant or breast feeding
  • Patients will be excluded if they have any T1 or M1, and T2N0 cancer(Step 1)
  • 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
  • No uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
  • Patient must not have active autoimmune disease that has required systemic treatment in the past 2 years
  • No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
  • No patients with immunodeficiency or receiving systemic steroid therapy equivalent to greater than 10 mg prednisone per day
  • Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Patients will be registered within 63 days following completion of standard chemoradiation for anal cancer(Step 2 only)
  • Patients must have received at least 54 Gy of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region) for the treatment of the anal cancer(Step 2 only)
  • Scans done within 4 weeks of randomization to Step 2

  • Applicable Disease Sites Anal

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics