Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Advanced Solid Cancers Clinical Trial

Official title: Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Status Terminated

Clinical Trial Summary

This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and tolerability of drug combination

Clinical Trial Description

This is an open-label, phase 1b trial of ADI-PEG 20 in combination with pembrolizumab in subjects with advanced cancers. Dose escalation will occur using a 3 + 3 + 3 design.

The first subject in a dose escalation cohort must have had treatment with ADI-PEG 20 + pembrolizumab with a week of follow up) before the next 2 subjects are enrolled. Thus subjects 2 and 3 may be enrolled on day 8 if there is no dose limiting toxicity (DLT) in subject 1. No additional delay is required between treating subjects 4 to 6 or 7 to 9 in an expanded cohort. Before proceeding to the next cohort dose level, the first 3 eligible subjects in each cohort will have received at least 21 days of treatment (i.e. at least 2 of the expected 3 doses of ADI-PEG 20 + one dose of pembrolizumab). ;

Related Conditions & MeSH terms

• Advanced Solid Cancers

• NCT number: NCT03254732
• Study type: Interventional
• Source: Polaris Group
• Status: Terminated
• Phase: Phase 1
• Start date: July 14, 2017
• Completion date: February 25, 2020