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

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Glioma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gastrointestinal Agents

Lactitol

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients in this study may receive:

- monotherapy of dabrafenib

Patients in this study may receive:

- monotherapy of trametinib

Patients in this study may receive:

- the combination of dabrafenib and trametinib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

dabrafenib

trametinib is available in tablets (0.5mg, 2mg dose)

trametinib

Novartis Pharmaceuticals

Angela Neuckranz

Michael Gordon

Michelle Capozzoli

Robert Kreitman

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Dabrafenib and/or Trametinib Rollover Study

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

To evaluate clinical benefit as assessed by the Investigator

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/or Trametinib Rollover Study	NCT03340506	Melanoma Non Small Cell ... Solid Tumor Rare Cancers High Grade Glio...	dabrafenib trametinib	18 Years - 100 Years	Novartis

Spots Global Cancer Trial Database for tafinlar

Every month we try and update this database with for tafinlar 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 tafinlar

Every month we try and update this database with for tafinlar 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 tafinlar 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.