Clinical Trial Information

Schema S1801

Protocol: SWOG – S1801

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

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 have histologically proven Stage IIIB or higher. This would entail pathologic confirmation beyond the primary or initial diagnosis of melanoma involving fine needle aspiration cytology or biopsy confirmation of any N-category or M-category resectable site.
5. 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. Patients must not be planning to receive any of the prohibited therapies listed in Section 7.2 during treatment phases on the study.
6. Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on
   protocol therapy.
7. 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.
8. Patients must be ≥ 18 years of age.
9. All patients must have disease status documented by a complete physical examination and imaging studies within 42 days prior to
   randomization. Imaging studies must include a total body PET-CT scan that is of diagnostic quality with iodine contrast-enhanced images (with or without brain) or a CT of the chest, abdomen and pelvis with intravenous contrast. For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with intravenous contrast or iodine contrastenhanced PET-CT through the region) is required. If the patient has unknown primary with disease in the axilla, neck imaging is required CT
   imaging should be done with intravenous contrast if there are no contraindications for it.
10. All patients must have a CT or MRI of the brain within 42 days prior to randomization. The brain CT or MRI should be performed with
    intravenous contrast (unless contraindicated).
11. Patients must have Zubrod Performance Status ≤ 2.

Clinical Trial Information

Schema EA6141

Protocol: ECOG – EA6141

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

Eligibility:

1. All patients must be ≥ 18 years of age.
2. ECOG Performance status: 0 or 1.
3. Patients must have known BRAF mutational status of tumor; Wild-type (WT) or mutated, prior to randomization.
4. Patients must have unresectable stage III or stage IV melanoma. Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
5. Patients must have measurable disease.
6. Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment. Patients may not have had any prior PD-1/PD-L1 agent in the adjuvant setting.
7. Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting.
8. Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to randomization 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 ≥ 2 weeks prior to entering the study and recovered from any adverse events associated with treatment. Prior surgery must be ≥ 4 weeks from randomization 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 randomization.
10. Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab.
    NOTE: Patients are permitted to receive the seasonal influenza vaccine. If seasonal influenza vaccine is considered, killed vaccines should be recommended.
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 > 3 years prior to the time of randomization.

Clinical Trial Information

Schema EA6134

Protocol: ECOG – EA6134

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. 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.
   NOTE: Any patient with BRAFV600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial. Patients with uveal melanoma are not eligibile for this trial.
6. Patients must have BRAFV600 mutation, identified by an FDA-approved test at a CLIA-certified lab. If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test, Foundation Medicine.
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. Repeat imaging after SRS or surgical resection is not required so long as baseline MRI is within 4 weeks of registration. Patients with multiple brain metastases treated with SRS (w or w/o WBRT), are not an exclusion. Patients with definitive CNS metastases treated with only WBRT are ineligible. Patients with potential CNS metastases that are too small for treatment with either SRS or surgery (e.g. 1-2 mm) and/or are of uncertain etiology are potentially eligible, but need to be discussed with and approved by the Study PI.
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.