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 : November 16, 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 :||June 2019|
|Estimated Study Completion Date :||June 2019|
|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 and progression-free survival.
- 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.
- 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: Charles Theuer, MD, PhD||(858) firstname.lastname@example.org|
|United States, Alabama|
|University of Alabama, Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Study Director:||Charles Theuer, MD, PhD||Medical Monitor|