Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC
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|ClinicalTrials.gov Identifier: NCT03181308|
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Carotuximab (TRC105) Drug: OPDIVO||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Dose-Escalation Study of Carotuximab (TRC105) in Combination With Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: TRC105 plus Nivolumab||
Drug: Carotuximab (TRC105)
Anti Endoglin Antibody
Other Name: TRC105
Programmed Death Receptor-1
Other Name: Nivolumab
- Phase 2 dose of carotuximab (TRC105) plus nivolumab [ Time Frame: Approximately 2-8 months ]Safety and tolerability will be evaluated in order to determine a recommended Phase 2 dose for carotuximab when added to standard dose nivolumab in patients with metastatic NSCLC.
- Response rate [ Time Frame: Approximately 2-8 months ]Preliminary evidence of antitumor activity of carotuximab (TRC105) plus nivolumab will be evaluated, by assessing response rate.
- Trough carotuximab (TRC105) concentrations [ Time Frame: Approximately 2-8 months ]Trough (pre-dose) serum carotuximab (TRC105) concentrations will be measured using validated ELISA methods.
- Development of immunogenicity antibodies [ Time Frame: Approximately 2-8 months ]The formation of carotuximab (TRC105) anti-product antibodies (APA) will be evaluated.
- Progression-free survival [ Time Frame: Approximately 2-8 months ]Preliminary evidence of antitumor activity of carotuximab (TRC105) plus nivolumab will be evaluated, by assessing progression-free survival.
- Trough nivolumab concentrations [ Time Frame: Approximately 2-8 months ]Trough (pre-dose) serum nivolumab concentrations will be measured using validated ELISA methods.
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): NCT03181308
|Contact: Brian E Simpson||858 550 0780 ext firstname.lastname@example.org|
|Contact: Bonne Adamsemail@example.com|
|United States, Alabama|
|University of Alabama||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Sarah Hall|
|Principal Investigator:||Francisco Robert, MD||PI|