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

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Protein Kinase Inhibitors

Enzyme Inhibitors

2 mg of Trametinib daily by mouth in 28 day cycles

Christoph Heuck, MD

The purpose of this study is to evaluate the overall response rate of Trametinib when administered orally to patients with relapsed or refractory multiple myeloma

The effect of on tumor response will be determined using the International Myeloma Working Group uniform response criteria by analyzing changes in serum and urine values of monoclonal protein immunoglobulin kappa and lambda free light chain and ratio, microglobulin, lactate dehydrogenase, hemoglobin and C-reactive proten.

UARK 2014-08 A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib

A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib in Patients With Relapsed of Refractory Multiple Myeloma

University of Arkansas

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Trametinib will be dosed at 1mg, 1.5mg, and 2mg orally (PO) daily based on Phase I data of this drug as a single agent. All patients entering this study will receive intravenous (IV) nab-paclitaxel on Day 1, 8, and 15. Dose levels will be assigned to each patient, and dose escalation decisions will be based on the evaluation of safety data from the prior cohort.

trametinib

nab-paclitaxel

Jeffrey R. Infante, MD

This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in trials of patients with melanoma. However, the combination of these two drugs has not been studied. In this trial the investigators will determine the maximum dose of the drug combination to be administered to patients with advanced unresectable or metastatic melanoma and examine the safety profile of the drug combination.

While treatment for melanoma has evolved in the last few years, advanced/metastatic melanoma remains an aggressive disease with poor prognosis. Trametinib and nab-paclitaxel have demonstrated single-agent activity in Phase III trials of patients with melanoma. The investigators propose to investigate this drug combination in patients with advanced unresectable or metastatic melanoma. This open-label Phase I study is designed to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and safety profile of trametinib and nab-paclitaxel given in combination. Patients with melanoma and known BRAF mutation status will receive escalating doses of trametinib and nab-paclitaxel to determine the MTD. Once the MTD is determined an additional 6 patients will be treated at the MTD to establish the dose for future studies.

Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

Phase I Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

The maximum tolerated dose (MTD) of the drug combination will be determined as the highest dose at which ≤1 of 6 patients experience a dose limiting toxicity (DLT) during one cycle (28 days) of therapy.

Celgene

GlaxoSmithKline

SCRI Development Innovations, LLC

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

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)

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
UARK 2014-08 A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib	NCT02140840	Multiple Myelom...	Trametinib	18 Years -	University of Arkansas
UARK 2014-08 A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib	NCT02140840	Multiple Myelom...	Trametinib	18 Years -	University of Arkansas
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
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma	NCT02300935	Melanoma	trametinib nab-paclitaxel	18 Years -	SCRI Development Innovations, LLC
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma	NCT02300935	Melanoma	trametinib nab-paclitaxel	18 Years -	SCRI Development Innovations, LLC
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 mekinist

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

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