Clinical Trials

Cancer Type: Melanoma and other Skin Cancers


2011-356

ECOG E1609: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma.

The purpose of this study is to compare the effects, good and/or bad, of ipilimumab with interferon alpha-2b on you and your melanoma cancer to find out which is better. In this study you will get either ipilimumab or the interferon alpha-2b. You will not get both. We plan to determine whether ipilimumab stops or delays your cancer from returning in comparison to interferon alpha-2b.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

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Contact : Jenny Crawford
Email: crawforjg@georgetown.edu
Phone: 202-687-0893

2012-1048

ML28305: Analysis of the Kinetics and Effects of Vemurafenib on Intratumoral and Host Immunity in Patients with Advanced BRAF V600 Mutant Melanoma.

The purpose of this study is to assess immunologic changes in the metastatic melanoma microenvironment of patients with BRAFV600E mutant melanoma treated with vemurafenib.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Franklink Square Hosptial Center; Washington Hospital Center

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Contact: Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007

2013-0126

A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma

This is a study for patients with metastatic melanoma. Once a patient joins the study, they will randomly be put into one of three study groups. Two of these groups will receive the investigational study drug MK-3475. One of the MK-3475 groups will receive the drug every 2 weeks and the other every 3 weeks. The second group will receive the drug ipiluminab.

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2013-0567

The NEMO trial-A randomized Ph III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus Dacarbazine in patients with previously untreated advanced unresectable or metastatic NRAS mutation-positive melanoma

This study is for patients with untreated advanced unresectable or metastatic melanoma harboring NRAS mutation (i.e. a very specific type of advanced skin cancer). This study is being done to find out if the drug MEK162 is safe and to learn about the effects (good and bad) in people with advanced unresectable or metastatic melanoma compared with the common treatment, Darcarzabine.

Patients will be seen every 3 weeks until treatment is stopped. Patients will be randomized to one of the treatment arms and will compelte questionnaires periodically during the study. There is a biomarker component to the study and an optional consent for future research. Patients will be followed for survival until the study ends.

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Pro-791

A Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) with or without Bevacizumab in Patients with Stage IV BRAFV600 Mutant Melanoma.

The purpose of this study is to compare the efficacy and safety of vemurafenib versus the combination of vemurafenib and bevacizumab in patients with Stage IV BRAFV600 mutant melanoma.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

Forms:

Contact: Holly DiFebo
Email: hmd27@georgetown.edu
Phone: 202-687-2007

2013-0514

CA209-067: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab in Combination with Ipilimumab Versus Ipilimumab Monotherapy in Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) or ipilimumab combined with nivolumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. An investigational drug is one that is not approved by the US Food and Drug Administration (FDA) or any other agency and is being studied and developed.
Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma. Ipilimumab is an antibody that acts against CTLA-4. An antibody against CTLA-4 can stop CTLA-4 from turning off the immune system, allowing the immune reaction to continue. Your body’s immune reaction may help your body to destroy cancer cells.
The effectiveness of nivolumab or ipilimumab combined with nivolumab in melanoma will be determined by comparing the survival of subjects who receive the investigational drug nivolumab or ipilimumab combined with nivolumab to those who receive ipilimumab alone.

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2013-0270

Title: CA209004 (MDX1106-04): A Phase 1b, Open-Label, Multicenter, Multidose, Dose-Escalation Study of MDX-1106 (BMS-936558) in Combination with Ipilimumab (BMS-734016) in Subjects with Unresectable Stage III or Stage IV Malignant Melanoma

Description: This study is for patients with melanoma that is resistant to or has recurred following other treatments.

The purpose of this study is to test the safety and tolerance of taking two experimental drugs, MDX-1106 (also known as BMS-936558) and ipilimumab (also knowns as BMS-734016). Both drugs are being used to see if they may be able to treat melanoma that is resistant to or has relapsed following other treatments previously taken for that cancer. Laboratory research in animals show that these drugs taken together may work better than each drug taken individually, and may kill the melanoma cancer cells or cause them to slow down or stop growing completely.

All patients treated on this study will receive both drugs as intravenous (into a vein) infusions.

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