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Clinical Trial 19694
Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03502746
Phase: Phase II
Prinicipal Investigator: Alberto Chiappori
Study Title
Phase II Study of Nivolumab and Ramucirumab for Patients with Previously-Treated Mesothelioma
Summary
This study will evaluate the combination of Nivolumab and Ramucirumab in patients with previously-treated mesothelioma.
Objective
PRIMARY OBJECTIVES: Evaluate response rate [complete response (CR) + partial response (PR)] of nivolumab in combination with ramucirumab in subjects with previously-treated mesothelioma. Response assessment will be performed using modified RECIST 1.1 criteria as described by Byrne et al. SECONDARY OBJECTIVE(S): Characterize adverse effects (AE) of nivolumab in combination with ramucirumab in subjects with previously-treated mesothelioma. Measure progression-free survival (PFS) rate at 24 weeks with the combination of the anti-Programmed Death 1 (PD-1) agent, nivolumab and the anti-vascular endothelial growth factor receptor 2 (VEGFR2) antibody, ramucirumab in subjects with previously-treated mesothelioma. Measure overall survival (OS) at 2 years after treatment with nivolumab in combination with ramucirumab in subjects with previously-treated mesothelioma. CORRELATIVES OBJECTIVES: Correlate programmed death-ligand 1 (PD-L1) expression in tumor tissue (from biopsy before treatment) with best clinical response (modified RECIST 1.1 criteria) in subjects with previously-treated mesothelioma. Correlate change in PD-L1 expression in tumor tissue from before therapy (assessed within 14 days before treatment) to after 4 cycles (8 weeks) of therapy with best clinical response (modified RECIST 1.1 criteria) at the end of Cycle 4 (Week 8) in subjects with previously-treated mesothelioma. Correlate cytokine genes expressions and change in tumor tissue (such as IL-1, IL-2, IL-6, GM-CSF, IL-10, IL-12, T-bet, IRF1, IFNã, CXCL1, CXCL9, CXCL10, CCL2 and 5) from before therapy (assessed within 14 days before treatment) to after 4 cycles (8 weeks) of therapy with best clinical response (modified RECIST 1.1 criteria) at the end of Cycle 4 (Week 8) in subjects with previously-treated mesothelioma. Correlate change in soluble PD-L1 level in plasma during therapy (assessed pre-dose Cycles 1 and 5 [Days 1 and 57 of treatment period, respectively]), with best clinical response (modified RECIST 1.1 criteria) at the end of Cycle 4 (Week 8) in subjects with previously-treated mesothelioma. Correlate change in number of CD8+, Granzyme B+ T cells in tumor tissue from before therapy (assessed within 14 days before treatment) to after 4 cycles (8 weeks) of therapy with best clinical response (modified RECIST 1.1 criteria) at the end of Cycle 4 (Week 8) in subjects with previously-treated mesothelioma.
Therapies
Medications
BMS-936558 (Nivolumab); IMC-1121B (Ramucirumab); Nivolumab (Opdivo); Ramucirumab ()
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