Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC
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|ClinicalTrials.gov Identifier: NCT03181308|
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Carotuximab (TRC105) Drug: OPDIVO||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 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|
|Actual Primary Completion Date :||July 22, 2019|
|Actual Study Completion Date :||July 22, 2019|
|Experimental: TRC105 plus Nivolumab||
Drug: Carotuximab (TRC105)
Anti Endoglin Antibody
Other Name: TRC105
Programmed Death Receptor-1
Other Name: Nivolumab
- Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Approximately 2-8 months ]For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, Febrile neutropenia: Grade 4 neutropenia with fever >38.5ºC both sustained over a ≥24-hour period, neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, Grade ≥4 thrombocytopenia or Grade ≥3 thrombocytopenia with Grade ≥3 hemorrhage, or grade 3 or 4 nonhematologic toxicity with the following exceptions: asymptomatic electrolyte abnormality that is corrected to Grade 1 or better in <72 hours, grade 3 headache lasting <48 hours. See protocol for Immune related DLT criteria.
- 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. The best response was measured to iRECIST by MRI or CT scans for each patient with measurable disease who received at least 1 dose of study drug.
- Trough Carotuximab (TRC105) Concentrations [ Time Frame: 8 weeks ]Trough (pre-dose) serum carotuximab (TRC105) concentrations will be measured using validated ELISA methods.
- Development of Immunogenicity Antibodies [ Time Frame: Approximately 2-8 months ]Number of Participants with carotuximab (TRC105) anti-product antibodies (APA)
- 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
|United States, Alabama|
|University of Alabama, Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Study Director:||Charles Theuer, MD, PhD||Medical Monitor|