18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose Limiting Toxicity (DLT)Primary· 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 correct
Group
Value
95% CI
8 mg/kg TRC105 + Nivolumab
0
10 mg/kg TRC105 + Nivolumab
0
8 mg/kg TRC105 + Nivolumab
3
10 mg/kg TRC105 + Nivolumab
0
8 mg/kg TRC105 + Nivolumab
0
10 mg/kg TRC105 + Nivolumab
0
8 mg/kg TRC105 + Nivolumab
0
10 mg/kg TRC105 + Nivolumab
8
Response RateSecondary· 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 (pre-dose) serum carotuximab (TRC105) concentrations will be measured using validated ELISA methods.
Group
Value
95% CI
8 mg/kg TRC105 + Nivolumab
65233
46400 – 82700
10 mg/kg TRC105 + Nivolumab
93600
72600 – 121000
Development of Immunogenicity AntibodiesSecondary· Approximately 2-8 months
Number of Participants with carotuximab (TRC105) anti-product antibodies (APA)
Group
Value
95% CI
8 mg/kg TRC105 + Nivolumab
0
10 mg/kg TRC105 + Nivolumab
0
8 mg/kg TRC105 + Nivolumab
3
10 mg/kg TRC105 + Nivolumab
3
Trough Nivolumab ConcentrationsSecondary· Approximately 2-8 months
Trough (pre-dose) serum nivolumab concentrations will be measured using validated ELISA methods.
Group
Value
95% CI
8 mg/kg TRC105 + Nivolumab
65233
46400 – 82700
10 mg/kg TRC105 + Nivolumab
93600
72600 – 121000
Adverse events — posted to ClinicalTrials.gov
Time frame: From screening until completion of follow-up, on average 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
8 mg/kg TRC105 + Nivolumab
Serious: 0/3 (0%)
Deaths: 0/3
10 mg/kg TRC105 + Nivolumab
Serious: 4/8 (50%)
Deaths: 0/8
Serious adverse events (6 terms)
Reaction
System
8 mg/kg TRC105 + Nivolumab
10 mg/kg TRC105 + Nivolumab
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a multi-center, open-label, nonrandomized, dose-escalation, Phase 1b study of carotuximab in combination with standard dose nivolumab in patients with NSCLC that has progressed on or after platinum-based chemotherapy or PD-1/PD-L1 checkpoint inhibition, as a single agent or with chemotherapy.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Other Tracon Pharmaceuticals Inc. trials
Trials by the same sponsor.
NCT02987829 — Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients
· Phase 1, PHASE2
· completed
NCT02979899 — Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma
· Phase 3
· completed
NCT01975519 — A Phase 1B Dose-escalation and Phase 2a Study of Carotuximab (TRC105) in Combination With Pazopanib in Patients With Adv
· Phase 1, PHASE2
· completed
NCT01806064 — Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma
· Phase 1, PHASE2
· terminated
NCT02354612 — Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial
· no longer available
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tracon Pharmaceuticals Inc.
Last refreshed: 24 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03181308.