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Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib in Patients With BRAF or NRAS-mutated Metastatic Melanoma

2016-09-22 21:08:21 | BioPortfolio

Summary

The goal of this clinical research study is to learn if nivolumab and trametinib (with or without dabrafenib) can help to control metastatic melanoma in patients who have a BRAF, NRAS, or BRAF-wild-type mutation.

The safety of these drug combinations will also be studied.

Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on the type of mutation you have.

- If you are in Group A, you will receive nivolumab, dabrafenib, and trametinib (BRAF-mutated patients).

- If you are in Group B, you will receive nivolumab and trametinib (BRAF-wild-type or NRAS-mutation patients).

You and the study staff will know which group you have been assigned.

Study Drug Administration:

Each study cycle is 4 weeks.

You will take trametinib by mouth every day while you are on study. Each dose should be taken about 12 hours apart (1 dose in the morning, 1 dose in the evening) with a cup of water (about 8 ounces), either 1 hour before or 2 hours after a meal.

You will also receive nivolumab by vein over about 30 minutes on Days 1 and 15 of each cycle.

If you are in Group A, you will also take dabrafenib at the same time you take your dose of trametinib.

If you vomit after your dose of study drugs, do not retake the dose. Wait until your next scheduled dose. If you are in Group A and you miss a dose of dabrafenib, you may take the dose as soon as you remember, as long as your next dose is more than 6 hours later. If you miss a dose of trametinib, you may take the dose as soon as you remember as long as the next dose is scheduled for at least 12 hours later.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after about 3 years of follow-up (described below).

Study Visits:

During Week 1 of Cycle 1:

- You will have a physical exam, including a skin exam.

- Blood (about 5 teaspoons) will be drawn for routine tests and to check your autoimmune status.

During Weeks 2 and 4 of Cycles 1-3 and Week 3 of Cycle 3, blood (about 3 teaspoons) will be drawn for routine tests.

During Week 3 of Cycle 1:

- You will have a physical exam, including a skin exam.

- Blood (about 3 teaspoons) will be drawn for routine, PD, and PBMC testing.

During Week 1 of Cycle 2:

- You will have a physical exam, including a skin exam.

- You will have an EKG.

- You will have an eye exam.

- Blood (about 5 teaspoons) will be drawn for routine and pharmacokinetic (PK) testing before your dose of study drug. PK testing measures the amount of study drug in the body at different time points.

During Week 3 of Cycle 2:

- You will have a physical exam, including a skin exam.

- Blood (about 3 teaspoons) will be drawn for routine tests.

During Week 1 of Cycles 3 and beyond:

- You will have a physical exam, including a skin exam.

- You will have an EKG.

- Blood (about 3 teaspoons) will be drawn for routine tests. During Cycle 3, this blood sample will also be used for PD and PBMC testing.

At Months 3 and 6 and then every year after that (if the study doctor thinks it is needed), you will have an eye exam.

Every 12 weeks:

- You will have an MRI or CT scan.

- You will have an ECHO.

End-of-Treatment Visit:

About 30 days after your last dose of study drugs:

- You will have a physical exam.

- You will have an EKG.

- Blood (about 2 teaspoons) will be drawn for routine, PD, and PBMC testing.

- You will have an MRI or CT scan.

- If the study doctor thinks it is needed, you will have an eye exam.

Long-Term Follow-Up:

After you stop taking the study drugs, the study doctor or study staff will continue to check on your health every 3 months for up to 3 years. This information may be collected at your routine, standard of care clinic visits; it may be collected from your medical records; or you may be called by the study staff and asked. If you are called, it should take about 10 minutes.

Your participation will be over after you have completed long-term follow-up.

This is an investigational study. Nivolumab, trametinib, and dabrafenib are each FDA approved and commercially available for the treatment of melanoma. However, it is considered investigational to use these drugs in combination with each other to treat melanoma. The study doctor can explain how the study drugs are designed to work.

Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

Nivolumab, Dabrafenib, Trametinib

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-22T21:08:21-0400

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