NCT02563548

A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors

A Phase 1B Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan-High Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).

Detailed description

Study involves dose escalation phase (completed in Nov-2016) to assess the safety and tolerability of PEGPEM (PEGylated recombinant human hyaluronidase \[PEGPH20\] combined with pembrolizumab \[Keytruda®\]) and to find the recommended Phase 2 dose (RP2D) ; and an expansion phase to assess the efficacy, safety and tolerability of PEGPEM in stage III b/IV NSCLC and relapsed/refractory GAC participants. Plan was to include approximately 51 HA-high participants (30 NSCLC and 21 GAC participants) in the dose expansion phase on the obtained RP2D from dose escalation phase of the study.

Conditions

• NSCLC
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	PEGPH20	PEGPH20 will be administered as an intravenous (IV) infusion as per the dose schedule specified in the arm description.
DRUG	Pembrolizumab	Pembrolizumab will be administered as an IV infusion as per the dose schedule specified in the arm description.

Timeline

• Start date: 2015-10-22
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2015-09-30
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study