Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
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|ClinicalTrials.gov Identifier: NCT03254732|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Cancers||Drug: ADI PEG20 Drug: Pembrolizumab||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers|
|Actual Study Start Date :||July 14, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: ADI-PEG 20
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.
Drug: ADI PEG20
ADI is a recombinant protein cloned from M. hominis and produced in E. coli, and conjugated with PEG of 20,000 mw. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.
Other Name: Keytruda®
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with Pembrolizumab in Advanced Solid Cancers [ Time Frame: Up to 36 months ]Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding
- Number of Participants with PFS with Combination ADI-PEG 20 and Pembro. [ Time Frame: Assessments ever 9 weeks for 12 months ]Progression Free Survival determined by RECIST 1.1
- Number of Participants with RR with Combination ADI-PEG 20 and Pembro. [ Time Frame: Assessments ever 9 weeks for 12 months ]Response Rate determined by RECIST 1.1
- Overall Survival [ Time Frame: 12 months after end of treatment ]Follow-Up by Phone or Clinic Visit
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254732
|Contact: John Bomalaski, M.D.||858-452-6688 ext firstname.lastname@example.org|
|Facility National Cheng Kung University||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Tsai-Yun Chen, M.D.|