Metastatic Melanoma Clinical Trial
Official title:
Phase Ib/II Clinical Trial of Glembatumumab Vedotin and Nivolumab in Advanced Solid Tumors
This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as glembatumumab vedotin, nivolumab, and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) for the combination of glembatumumab
vedotin and nivolumab in patients with solid tumors. (Phase Ib) II. To evaluate the antitumor
activity of the combination in 4 expansion cohorts (melanoma, uveal melanoma, GPNMB
overexpressing triple negative breast cancer [TNBC], other GPNMB overexpressing solid tumors)
as measured by overall response by Immune-Modified Response Evaluation Criteria in Solid
Tumors (iRECIST)/Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II)
SECONDARY OBJECTIVES:
I. To characterize the safety and toxicity profile of the combination. II. To evaluate the
clinical benefit rate (no disease progression within 6 months), progression free survival
(PFS), and overall survival (OS) in patients receiving the combination treatment.
III. To evaluate the pharmacokinetics (PK) of glembatumumab vedotin and nivolumab in
combination in serum and in mononuclear phagocyte system (MPS) cells in peripheral blood
mononuclear cells.
IV. Profile differences in the type, number and density of Fc-receptors (FcgammaR) on MPS
cells in blood of patients prior to and after administration of glembatumumab vedotin and
nivolumab as a method to evaluate the factors affecting PK and pharmacodynamics (PD)
variability and mechanisms of drug-drug interactions.
V. Characterize differences in chemokines (CCL2 and CCL5) and other cytokines in blood of
patients prior to and after administration of glembatumumab vedotin and nivolumab as a method
to evaluate the factors affecting PK and PD variability and mechanisms of drug-drug
interactions.
VI. To evaluate the pharmacodynamic (PD) effects of the combination in plasma and tissue
biomarkers.
OUTLINE:
Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes and nivolumab IV
over 60 minutes on day 8 of course 1 and on day 1 of subsequent courses. Patients in melanoma
expanded cohort also receive ipilimumab IV over 90 minutes on day 1. Treatment with
ipilimumab repeats every 21 days for 4 courses in the absence of disease progression or
unaccepted toxicity and courses with glembatumumab vedotin and nivolumab repeat every 21 days
in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then at 30 and
70 days.
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