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ProtocolTrial Name and Objective
131213

Sun Protection and Skin Surveillance: Beliefs and Behaviors of Childhood Cancer Survivors

To establish the prevalence and correlates of skin cancer prevention and surveillance behaviors among CCS using depth interviews and survey research.
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091302

ECOG E3611, A Randomized Phase II Study of Ipilimumab at 3mg/kg or 10mg/kg Alone or in Combination with High Dose Interferon-alpha in Advanced Melanoma

The purpose of this study is to compare the effects, good and/or bad, of ipilimumab (given at 2 different doses, 10 mg/kg or 3 mg/kg) either alone or in combination with interferon alfa-2b on you and your melanoma to find out which treatment is safer and better. Therefore, you will get ipilimumab (either at 10 mg/kg or 3 mg/kg) alone or in combination with interferon alfa-2b.
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090906

NCI/CTEP #8850: A Phase I Trial of Riluzole and Sorafenib in Patients with Advanced Solid Tumors and Melanoma (CDUS)

The overall goal of this project is to determine if pharmacological blockade of the metabotropic glutamate receptor 1 (GRM1) signaling pathway with the agent Riluzole, combined with inhibition of RAF signaling with the agent Sorafenib, will result in clinically evident responses in patients with stage IV melanoma.
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091201

A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence

Part A Objectives
␣ To evaluate the safety of POL-103A in patients with stage IIB, IIC, or III melanoma. ␣ To evaluate the biological activity of POL-103A in patients with stage IIB, IIC, or III
melanoma. ␣ To select the dose for Part B. ␣ To collect blood samples for the future investigation of the sustained biologic activity
of POL-103A.
Part B Objectives Primary Objective
␣ To assess the efficacy of treatment with POL-103A compared to placebo with respect to recurrence-free survival or overall survival
Secondary Objectives
2.2 2.2.1
2.2.2
␣ To verify the safety and tolerability of POL-103A at the dose selected for Part B.
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051208

TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795

Primary: Part 1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part 1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently). Part 2A, 2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
Secondary: (1) To characterize the PK of GSK1120212 and GSK2141795 for a once daily continuous dosing schedule (Part 1A) and/or an intermittent dosing schedule (Part 1B). (2) Part 1A, Part 1B to evaluate the clinical activity of GSK1120212 and GSK2141795 in subjects with solid tumors. (3) Parts 1 and 2, to characterize the durability of response with GSK1120212 and GSK2141795 dosed orally in combination. (4) To evaluate the pharmacodynamic (PD) response in tumors after treatment with the combination of GSK1120212 and GSK2141795. (5) To explore relationships between study drug PK, PD and clinical activity.
Translational: To explore the association of clinical and PD endpoints with genetic and protein profiles from blood and/or tumor tissue.
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