UPCC 02614: The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/2 Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma.

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UPCC 02614: The BAMM Trial: BRAF, Autophagy and MEK inhibition in Metastatic Melanoma: A Phase I/2 Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients with Advanced BRAF Mutant Melanoma.

1.1 Primary Objective
Phase 1: To determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.
Phase 2: To assess the clinical efficacy of HCQ+D+T by 1 year PFS rate .
1.2 Secondary Objectives
1.2.1 To estimate the toxicity rates of oral HCQ when administered in conjunction with oral D+T.
1.2.2 To measure the response rate by RECIST criteria, and 1-year survival.
1.2.3 To determine the rate of squamous cell carcinoma of the skin, arthralgias, and pyrexia in patients treated with D+T and HCQ
1.2.4 To determine the type and frequency of ocular toxicities with this regimen
1.3 Correlative Objectives
1.3.1 To establish a population pharmacokinetic (PK) model for HCQ and its metabolites in combination with D+T
1.3.2 To use the population PK model to estimate the exposure of HCQ in individual patients
1.3.3 To compare PK parameters for HCQ and D+T in combination to data from published dabrafenib and trametinib single agent and combination studies
1.3.4 To measure the change in median number of autophagic vesicles/cell (mAV/cell) in serially collected tumor tissue with D+T alone and with D+T + HCQ and correlate these changes with HCQ exposure
1.3.5 To determine if markers of T cell immunity are increased or decreased in D+T and D+T + HCQ treated tumor compared to baseline
1.3.6 To characterize changes in gene expression within the tumor microenvironment with D+T+ HCQ treatment in patients.
1.3.7 To evaluate whether or not treatment results in modulation of systemic immunity by assessing peripheral cytokine levels
1.3.8 To determine if blood based candidate biomarkers of autophagy modulation reflect autophagy dynamics in tumors of patients

Protocol Number: 091503
Phase: Phase I/II
Applicable Disease Sites: Melanoma, skin
Drugs Involved: DABRAFENIB
Trametinib
Hydroxychloroquine
Principal Investigator: Janice Mehnert
Research Nurse: Jennifer Bryan
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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