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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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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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091311

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma

Phase 1b: To determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Phase 2: To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as assessed by overall survival (OS) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.
Secondary Objective(s):
Phase 1b:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab as
determined by objective response rate (ORR)
To assess the safety of talimogene laherparepvec in combination with ipilimumab as determined by incidence of all adverse event (AE)s, grade ? 3 AEs (AEs), serious adverse events (SAEs), and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs not defined as DLT
Phase 2:
To estimate the efficacy of talimogene laherparepvec in combination with ipilimumab versus
ipilimumab alone as determined by ORR, duration of response (DOR), time to response (TTR), progression free survival (PFS), resection rate, 1-year survival rate, and 2-year survival rate
To assess the safety of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone as determined by incidence of all AEs, grade ? 3 AEs, SAEs, and events requiring the discontinuation of study drug, local effects on the tumor (ie, pain, inflammation and ulceration), clinically significant laboratory changes, and clinically significant changes in vital signs
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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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091401

EMR 100070-003: A Phase 2, open-label, multicenter trial to investigate the clinical activity and safety of MSB0010718C in subjects with Merkel cell carcinoma

The primary objective of the trial is to assess the clinical activity of MSB0010718C in subjects with metastatic Merkel cell carcinoma (MCC) as determined by the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by an Independent Endpoint Review Committee (IERC).

Secondary objectives are as follows:
To assess the duration of response according to RECIST 1.1
To assess the progression-free survival time (PFS) according to RECIST 1.1
To assess the safety profile of MSB0010718C in subjects with MCC
To assess the overall survival (OS) time

Exploratory objectives are as follows:
To characterize the pharmacokinetic (PK) profile of MSB0010718C
To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure and biological activity
To assess the immune-related best overall response (irBOR) and immune-related PFS (irPFS) using the modified immune-related response criteria (irRC), derived from RECIST 1.1
To evaluate changes in biomarkers in relation to disease responses to MSB0010718C
To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and best overall response (BOR)
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051306

A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

To assess the safety and tolerability of MSB0010718C and to determine the maximum tolerated dose (MTD) of MSB0010718C in subjects with metastatic or locally advanced solid tumors.
Secondary objectives
- To characterize the pharmacokinetic (PK) profile of MSB0010718C and to correlate exposure with target occupancy.
- To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure
and biological activity.
- To assess the best overall response (BOR) andprogression-free survival time (PFS) according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1.
- To assess the immune-related BOR (irBOR) and immune-related PFS (irPFS) using the modified Immune-Related Response Criteria (irRC),
derived from RECIST 1.1.
- To assess overall survival time (OS).
- To evaluate biological responses to MSB0010718C in blood/serum.
- To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and BOR.
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091312

A safety study for MSB0010445 in combination with Stereotactic Body Radiation in advanced melanoma subjects following prior treatment with ipilimumab

The primary objective of the trial is as follows:
- To determine the maximum tolerated dose (MTD) of MSB0010445 in combination with Stereotactic Body Radiation Therapy (SBRT) in subjects with advanced melanoma
The exploratory objectives of the trial are as follows:
- To establish that MSB0010445 in combination with SBRT is clinically active through the observation of best overall response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- To further characterize the safety of MSB0010445 in combination with SBRT
- To characterize the immunogenicity of MSB0010445
- To characterize the pharmacokinetics (PK) of MSB0010445
- To propose that MSB0010445 in combination with SBRT is biologically active by observing modifications of the tumor microenvironment (by infiltration of CD8+ T cells and of regulatory T cell [Treg] in the tumor)
- To evaluate potential biomarkers of immune response correlated with clinical activity by analysis of tumor and peripheral blood samples
- To establish that MSB0010445 is clinically active through the observation of best overall response assessed by modified immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- To evaluate the pharmacodynamic activity of MSB0010445 in combination with radiotherapy in peripheral blood
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091403

030-00: Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options

This is an expanded access program (EAP), multi-site, worldwide treatment use protocol in patients with metastatic melanoma who have limited or no treatment options. Patients must have progressed after prior systemic therapy including standard of care agents which include ipilimumab and BRAF/MEK inhibitor when indicated. Patients cannot be eligible for an available MK-3475 clinical trial or have participated in a MK-3475 clinical trial. Patients will be treated until progression of disease or until the patient has received up to 2 years of treatment. The Expanded Access protocol will be closed to new patients if MK-3475 is submitted for approval but not approved by the regulatory agency in
the relevant country.
The EAP is anticipated to enroll approximately 4500 patients worldwide. Participation will begin with informed consent (and assent, if appropriate) followed by a baseline evaluation to assess the patients eligibility for treatment. Patients will be evaluated for safety at baseline
and before each cycle of MK-3475.
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001402

Proleukin® Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Primary Objective
To establish an observational data to report and query on
Patient care patterns
* Clinical outcomes and trends from HD IL-2 therapy
in treating patients with mM, mRCC or other malignancies
Secondary Objectives
To evaluate patient/site specific prognostics and treatment emergent
outcomes associated with HD IL-2
To publish real-world practices of IL-2 immunotherapy on annual basis
To maintain an expandable database platform for future research interest
and projects relevant to IL-2 in mM and mRCC or other malignancies
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