Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02563548|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2015
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Gastric Cancer||Drug: PEGPEM Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan High Solid Tumors|
|Actual Study Start Date :||October 31, 2015|
|Estimated Primary Completion Date :||May 19, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: PEGPEM (PEGPH20 + pembrolizumab)
Dose-escalation phase: Participants will receive PEGPH20 administered intravenously (IV) on Day 1, Day 8, and Day 15 of each 21-day cycle (3 doses per cycle) and pembrolizumab administered IV (2 milligrams per kilogram [mg/kg] every 21 days) on Day 1 of each cycle (1 dose per cycle), 4 to 6 hours after the completion of PEGPH20 administration.
Dose-expansion phase: Participants will receive PEGPH20 administered IV at RP2D as determined in the dose-escalation phase on Day 1, Day 8, and Day 15 of each 21-day cycle and pembrolizumab 200 mg administered IV on Day 1 of each cycle, 4 to 6 hours after the completion of PEGPH20 administration.
Treatment in both phases of the study will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Other Name: Administered per the schedule specified in the arm description.
Administered per schedule specified in the arm description.
Other Name: Keytruda®
- Efficacy of PEGPH20 and pembrolizumab combination by Objective response rate (ORR) [ Time Frame: Expansion phase ]based on RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v.1.1) in Hyaluronan-high (HA-high) subjects
- Duration of response (DOR) based on RECIST v1.1 and immune related response criteria (irRC) [ Time Frame: Expansion phase ]during the expansion phase
- Disease control rate (DCR) based on RECIST v1.1 and irRC [ Time Frame: Expansion phase ]during the expansion phase
- PFS based on RECIST v1.1 and irRC [ Time Frame: Expansion phase ]during expansion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563548
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