Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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
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): 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.|