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A Randomized Phase II Study of Nivolumab After Combined Modality Therapy in High Risk Anal Cancer.

Research & Trial Information

SCHEMA

Protocol#: ECOG – EA2165

Cancer Type: Anal

Patient Eligibility:

  1. Age 18 years.
  2. 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.

  3. For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer.

  4. Patients must have ECOG performance status of 0-2.
  5. Patients known to be Human immunodeficiency virus (HIV)+ are permitted. Patients with CD4>200 and Serum HIV viral load of < 200 copies/mm3 are eligibile.

  6. For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration.

  7. Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.

  8. Patients will be excluded if they have any T1 or M1, and T2N0 cancer.
  9. Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.

  10. Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.

  11. Any surgery must have been completed 4 weeks prior to starting study treatment.

  12. Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

  13. Patient must not have active autoimmune disease in the past 2 years.
  14. No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody).

  15. No patients with immunodeficiency or receiving Nivolumab equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.

  16. No live vaccines within 30 days prior to registration.
  17. Registration to Step 2: Eligibility Criteria:
  18. Patients will be registered within 63 days following completion of standard chemoradiation for anal cancer.

  19. 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.

  20. 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.

  21. Patients must have ECOG performance status of 0-2.
  22. Scans done within 4 weeks of randomization to Step 2.
  23. Patient must be able to have recovered from all toxicities associated with chemoradiotherapy for anal cancer, to Grade ≤ 1 with the exception of alopecia.

  24. Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.

  25. Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.

  26. Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.

 

Genesys Hurley Cancer Institute

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Flint, MI 48503

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Hurley Medical Center
Michigan Cancer Consortium

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