Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03502746|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma, Malignant||Drug: Nivolumab Drug: Ramucirumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma:Hoosier Cancer Research Network LUN15-299|
|Actual Study Start Date :||June 26, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: Nivolumab + Ramucirumab
Nivolumab 240mg IV + Ramucirumab 8mg/kg IV
Nivolumab 240mg, IV over 30 minutes.
Other Name: Opdivo
8mg/kg, IV over 60 minutes.
Other Name: Cyramza
- Response Rate [ Time Frame: 24 months ]• 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.
- Adverse event assessment [ Time Frame: 24 months ]Assess adverse effects (AE) of nivolumab in combination with ramucirumab in subjects with previously-treated mesothelioma.
- Progression-free survival [ Time Frame: 24 weeks ]Measure progression-free survival (PFS) defined as time from registration until objective tumor progression or death 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.
- Overall survival [ Time Frame: 24 months ]Measure overall survival (OS) defined as time from registration until death from any cause at 2 years after treatment with nivolumab in combination with ramucirumab in subjects with previously-treated mesothelioma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502746
|Contact: Arkadiusz Z Dudek, MD||651-254-3321||Arkadiusz.Z.Dudek@HealthPartners.Com|
|Contact: Ahran Lee||3176345842 ext email@example.com|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Kelly Nicholls 813-745-7125 Kelly.Nicholls@moffitt.org|
|Principal Investigator: Alberto Chiappori, MD|
|United States, Minnesota|
|HealthPartners Institute Regions Cancer Care Center||Recruiting|
|Minneapolis, Minnesota, United States, 55440|
|Contact: Arkadiusz Dudek, MD 651-254-3321 Arkadiusz.Z.Dudek@HealthPartners.Com|
|Principal Investigator: Arkadiusz Dudek, MD|
|Principal Investigator:||Arkadiusz Z Dudek, MD||HealthPartners Institute Regions Cancer Care Center|