February 18, 2021 Anal

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.


April 7, 2020 Anal

Clinical Trial Information

PROTOCOL: ECOG-EA2165

SCHEMA EA2165

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

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.  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 theanal canal.
  3. Patients must have ECOG performance status of 0-2.
  4. For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration.
  5. Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.
  6. Patients will be excluded if they have any T1 or M1, and T2N0 cancer.
  7. Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
  8. Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
  9. Any surgery must have been completed ≥ 4 weeks prior to starting study treatment.
  10. 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.
  11. Patient must not have active autoimmune disease in the past 2 years.
  12. No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody).

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