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October 17, 2019 Melanoma

Research & Trial Information

SCHEMA S1801

Protocol#: SWOG – S1801

Cancer Type: Melanoma

Patient Eligibility:

  1. Patients must have resectable melanoma in order to be eligible for this study. Patients must have clinically detectable Stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or Stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with melanoma of uveal origin are not eligible. Patients with a history of brain metastases are not eligible. Clinically detectable is defined as disease that is apparent and measurable via physical examination or radiographic imaging.
  2. Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by H & E stained slides.
  3. Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
  4. Patients must not have received previous neoadjuvant treatment for their melanoma. Patients may have received prior non-immunotherapy adjuvant therapy. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies.
  5. Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on protocol therapy.
  6. Patients may have received prior radiation therapy, including after prior surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to ≤ Grade 1 prior to randomization.
  7. Patients must be ≥ 18 years of age.
  8. All patients must have disease status documented by a complete physical examination and imaging studies within 42 days prior to randomization.
  9. Patients must have Zubrod Performance Status ≤ 2.
  10. Prior malignancy is allowed providing it does not require concurrent therapy.


October 17, 2019 Melanoma

Research & Trial Information

SCHEMA EA6134

Protocol#: ECOG – EA6134

Cancer Type: Melanoma

Protocol Eligibility:

  1. Age 18 years.
  2. ECOG Performance status: 0 or 1.
  3. Patients must have unresectable stage III or stage IV disease.
  4. Patients must have measurable disease.
  5. Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.

  6. Patients must have BRAFV600 mutation.
  7. Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor. Also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease.

  8. Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting 4 weeks prior to entering the study and recovered from adverse events due to those agents. Mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study. Patients must have discontinued radiation therapy 1 week prior to entering the study and recovered from any adverse events associated with treatment. Prior surgery must be 2 weeks from registration and patients must be fully recovered from post surgical complications.

  9. Patients must not receive any other investigational agents while on study or within four weeks prior to registration.

  10. Patients are ineligible if they have any currently known active and definitive CNS metastases. Patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery (SRS)) could be eligible. Patients must not have taken any steroids ≤ 10 days prior to randomization for the purpose of managing their brain metastases.

  11. Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for > 2 years prior to the time of registration


Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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