For more information regarding these studies, contact Cancer Research & Registry at (601) 984-1095
S1320: A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
This experimental research study for the treatment of melanoma (skin cancer) that has a BRAF mutation. BRAF is a human gene that makes a protein called B-raf. This protein tells cells to grow. The study will compare the side effects (good and/or bad) of receiving the drugs dabrafenib and trametinib continuously versus receiving dabrafenib and trametinib with a break in treatment. The combination of dabrafenib and trametinib is approved by the FDA for the treatment of advanced melanoma and has been tested together and found to be safe and effective for patients with advanced melanoma. This study is testing whether receiving dabrafenib and trametinib with a break in treatment could extend the time before your cancer gets worse.
Principal Investigator: Natale Sheehan, MD
EA6134: A Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
This study is being done for melanoma that has spread beyond its local area and cannot be surgically removed. Additionally, participants will have tested positive for a BRAF mutation, which can lead to uncontrolled growth of the tumor cells.
Given that there are multiple treatment approaches now available for patients with advanced melanoma that contain a mutation in the BRAF protein, patients have a choice which treatment to receive first and thus the sequence of treatments. Currently there is no data on which treatment approach (initial treatment or sequence of treatments) yield the best outcome for a given patient or group of patients.
This study will compare the initial and subsequent sequence of immunotherapy followed by BRAF inhibitor therapy to BRAF inhibitor therapy followed by immunotherapy, if and when the disease becomes resistant, and compare the good and bad effects.
The BRAF inhibitor component will include two drugs dabrafenib and trametinib, each have been approved by the FDA for this disease. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence. Of note, the addition of nivolumab to ipilimumab could enhance the side effects of the immunotherapy component.
This research study will allow the investigators to determine which sequence of treatment has the best outcome for patients.
S1404: A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
The purpose of this study is to compare the effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) to the usual treatment with interferon alfa-2b. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than treatment with interferon alfa-2b. In this study, you will get either MK-3475 or interferon alfa-2b.
There will be about 1,378 people taking part in this study.
Principal Investigator: Barbara Craft, MD
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