A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment Naive Metastatic Anal Cancer Patients

February 18, 2021

Clinical Trial Information

Protocol: ECOG – EA2176

SCHEMA EA2176

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

  1. Patients must have inoperable, recurrent or metastatic disease (tumor resectability should be assessed by a local surgeon or a multidisciplinary team) not amenable to curative therapy.
  2. Patient must have histological or cytological confirmation or anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion.
  3. Patient must be at least 18 years of age.
  4. ECOG performance status 0-1.
  5. Patients must have measurable disease.
  6. Patient receiving palliative (limited field) radiation therapy is allowed, as long as the lesion treated for palliation is not a target lesion.
  7. Patients with brain metastasis are eligible if patient is asymptomatic and if treatment ended less than 3 months prior to randomization. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression within 4 weeks prior to randomization.
  8. Patients must not have had previous use of systemic chemotherapy or other investigational drugs for the treatment of inoperable recurrent or metastatic anal cancer (Previous use of radiotherapy or chemoradiotherapy in this setting is not an exclusion if 1. non-irradiated target tumor lesions are present at randomization for the purpose of tumor response assessment or 2. in the absence of non-irradiated target tumor lesions according to RECIST criteria version 1.1 is documented.
  9. Patient must not have current or recent (within 30 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
  10. Patients must not have had prior immunotherapy.
  11. Patient must not have a history of known hypersensitivity reaction to any platinum or taxane-based chemotherapy or monoclonal antibody.
  12. Patient must not have other primary malignancy within the last 3 years, except for adequately treated carcinoma of the skin, or adequately controlled limited basal cell skin cancer, or any other cancer from which the patient has been disease free for at least 3 years.

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Flint, MI 48503

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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