Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Vaccines

Trametinib

Dabrafenib

Monatide (IMS 3015)

Vemurafenib

Immunologic Factors

The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 36, 57, 78. All peptide vaccines are administered intradermally and subcutaneously.

A selective BRAF inhibitor and a selective MEK inhibitor will be administered in accordance with the prescribing information.

BRAF inhibitor

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

6MHP

MEK inhibitor

Elizabeth Gaughan, MD

Craig L. Slingluff, Jr., MD

This study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.

A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib

A TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A HELPER PEPTIDE VACCINE PLUS COMBINATION OF BRAF INHIBITION AND MEK INHIBITION (MEL61)

CD4+ T cell responses to the peptide vaccine

An evaluation of the development of antibdoy responses following vaccination

National Cancer Institute (NCI)

Craig L Slingluff, Jr

Professor of Surgery and Director, Human Immune Therapy Center

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive dabrafenib PO BID on days 1-28 (once daily on day 1 and BID on days 3-28 of course 1), and pazopanib hydrochloride PO QD on days 1-28 (days 2-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic studies: Blood draw for various time points:

Cycle 1 Days 1, 2, 3, 4 and 15; Cycle 2 Days 1, 2; and day 1 of Cycles 4, 6 and 12

* Pharmacogenomic studies: Blood draw on Cycle 1 Day 1
* Tumor genotyping: Archival tumor blocks or unstained slides
* BRAF mutation quantification in circulating plasma DNA: Blood draw on Cycles 1-7 Day 1 and every other cycle thereafter; and at time of progression

dabrafenib

pazopanib hydrochloride

Pharmacokinetic studies:

Blood draw for various time points:

Cycle 1 Days 1, 2, 3, 4 and 15; Cycle 2 Days 1, 2; and day 1 of Cycles 4, 6 and 12

* Pharmacogenomic studies: Blood draw on Cycle 1 Day 1
* Tumor genotyping: Archival tumor blocks or unstained slides
* BRAF mutation quantification in circulating plasma DNA: Blood draw on Cycles 1-7 Day 1 and every other cycle thereafter; and at time of progression

Correlative studies

Manisha Shah, MD

This phase I trial studies the side effects and best dose of dabrafenib and pazopanib hydrochloride when given together in treating patients with advanced malignant tumors. Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of GSK2118436 (dabrafenib) given with pazopanib (pazopanib hydrochloride) as well as determining the maximum tolerated dosing regimen in patients with BRAF mutated advanced malignant tumors.

SECONDARY OBJECTIVES:

I. Evaluate pharmacokinetics of the two study drugs and identify potential drug-drug interactions.

II. Determine pharmacogenomics with microarray testing. III. Perform genotyping of tumors and if objective tumor response rates are identified.

IV. Assess objective tumor response rates.

OUTLINE: This is a dose-escalation study.

Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily on day 1 and BID on days 3-28 of course 1), and pazopanib hydrochloride PO once daily (QD) on days 1-28 (days 2-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

A Phase I Trial of Dabrafenib (BRAFi) and Pazopanib in Patients With BRAF-mutated Advanced Malignant Tumors

We will summarize observed adverse events and their grade and attribution for each dose level, and patterns reflecting tolerability of the regimen explored through graphical analysis and descriptive summaries.

Comparisons of groups of patients based on clinical response or toxicity will involve the use of analysis of variance for continuous data and categorical methods such as Fisher's exact test and chi-square tests for discrete data.

Descriptive data will be computed and compared using analysis of variance and nonparametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib	NCT02382549	Melanoma	BRAF inhibitor 6MHP MEK inhibitor	18 Years -	University of Virginia
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib	NCT02382549	Melanoma	BRAF inhibitor 6MHP MEK inhibitor	18 Years -	University of Virginia
Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors	NCT01713972	Unspecified Adu...	dabrafenib pazopanib hydro... Correlative stu...	18 Years -	Ohio State University Comprehensive Cancer Center
Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors	NCT01713972	Unspecified Adu...	dabrafenib pazopanib hydro... Correlative stu...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for brafi

Every month we try and update this database with for brafi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for brafi

Every month we try and update this database with for brafi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for brafi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.