Vopratelimab and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Subjects With NSCLC or Urothelial Cancer

Official Title

Phase 2 Multicentre Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX -2011 and a CTLA-4 Inhibitor in PD-1/PD-L1 Inhibitor Experienced Adult Subjects With Non-small Cell Lung Cancer or Urothelial Cancer

Summary:

JTX-2011-201 is a Phase 2, open label clinical study of vopratelimab (JTX-2011) and ipilimumab in adult subjects with non-small cell lung cancer (NSCLC) or urothelial cancer to evaluate safety and efficacy.

Trial Description

Primary Outcome:

• % subjects with overall response (OR)

Secondary Outcome:

• % subjects with adverse events (AEs)
• % subjects with serious adverse events (SAEs)
• % subjects with clinically significant change from baseline in clinical laboratory tests
• % subjects with anti-drug antibodies (ADA) to treatment
• % of subjects with neutralizing antibodies (NAb) to treatment
• % of subjects with clinically significant changes in electrocardiogram (ECG) measurements
• Area under the serum concentration-time curve (AUC)
• Maximum measured concentration in serum (Cmax)
• Time from dosing to maximum measured concentration (tmax)
• Terminal half-life (t1/2)
• Total clearance of the analyte in serum (CL)
• Apparent volume of distribution during specific time points
• Median duration of response (DOR)
• Disease control rate (DCR)
• Landmark progression free survival (PFS)
• Median PFS
• Median overall survival (OS)

Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumour immune response. This is a Phase 2, open label study to evaluate the safety and efficacy of vopratelimab in combination with ipilimumab in adult subjects with advanced and/or refractory non-small cell lung cancer and urothelial cancer.

View this trial on ClinicalTrials.gov