Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Nivolumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Carotuximab (TRC105)

OPDIVO

Charles Theuer, MD, PhD

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.

Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC

A Phase 1b Dose-Escalation Study of Carotuximab (TRC105) in Combination With Nivolumab in Patients With Metastatic Non-Small Cell Lung Cancer

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.

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.

Number of Participants with carotuximab (TRC105) anti-product antibodies (APA)

Trough (pre-dose) serum nivolumab concentrations will be measured using validated ELISA methods.

Tracon Pharmaceuticals Inc.

Dose Level 1 8 mg/kg TRC105 + Nivolumab

Carotuximab (TRC105): Anti Endoglin Antibody

OPDIVO (Nivolumab): Programmed Death Receptor-1

8 mg/kg TRC105 + Nivolumab

Dose Level 2 10 mg/kg TRC105 + Nivolumab

Carotuximab (TRC105): Anti Endoglin Antibody

OPDIVO (Nivolumab): Programmed Death Receptor-1

10 mg/kg TRC105 + Nivolumab

Dose Level 1 8 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1

8 mg/kg TRC105 Plus Nivolumab

Dose Level 2 10 mg/kg TRC105 + Nivolumab Carotuximab (TRC105): Anti Endoglin Antibody OPDIVO (Nivolumab): Programmed Death Receptor-1

10 mg/kg TRC105 Plus Nivolumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Medical Monitor

All patients who received at least a portion of a dose of any study drug (TRC105, Nivolumab)

Number of Participants With Dose Limiting Toxicity (DLT)

iSD (Immune Stable Disease) Best Response

iPR (Immune Partial Response) Best Response

iPD (Immune Progressive Disease) Best Response

iCR (Immune Complete Response) Best Response

iUPD (Unconfirmed Immune PD) Best Response

Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination. Patients were scanned at baseline and every 8 weeks to determine disease status.

Response Rate

All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study. 6 patients had PK analysis completed.

Trough Carotuximab (TRC105) Concentrations

Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.

Development of Immunogenicity Antibodies

All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study. Only Cycle 2 Day 1 trough mean serum TRC105 concentrations were analyzed before study closure.

Spots Global Cancer Trial Database for Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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