NCT03502746

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma

Phase II Study of Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma:Hoosier Cancer Research Network LUN15-299

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Arkadiusz Z. Dudek, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the combination of Nivolumab and Ramucirumab in patients with previously-treated mesothelioma.

Detailed description

The programmed death ligand 1 (PD-L1) \[16\] and VEGFR2 \[34\] are highly-expressed on mesothelioma cells, and are therefore attractive options for this cancer. We chose to study the combination of ramucirumab with nivolumab because of the potential efficacy of these two agents in mesothelioma and because of the potential synergistic activity between them \[30\]. As previously discussed, immunotherapies such as anti-PD-1 inhibitors must contend with a hostile, immunosuppressive tumor microenvironment due to angiogenesis that results in hypoxia. This hypoxia decreases the ability of antibodies to infiltrate the tumor. We hypothesize that the normalization of tumor vasculature (by reducing the area of the tumor that is hypoxic) with an anti-VEGF strategy (i.e., ramucirumab) used in synergy with a PD-1 inhibitor will facilitate the infiltration of T-lymphocytes into tumor parenchyma. We will conduct a phase II study based on this premise using nivolumab and ramucirumab as second-line therapy in patients with malignant mesothelioma who have failed standard doublet platinum and anti-folate therapy.

Conditions

• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 240mg, IV over 30 minutes.
DRUG	Ramucirumab	8mg/kg, IV over 60 minutes.

Timeline

• Start date: 2018-06-26
• Primary completion: 2022-05-11
• Completion: 2023-11-09
• First posted: 2018-04-19
• Last updated: 2024-05-14
• Results posted: 2023-10-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study