Status:
TERMINATED
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Lead Sponsor:
Polaris Group
Conditions:
Advanced Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 combin...
Detailed 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 do...
Eligibility Criteria
Inclusion
- Select
- Histologically confirmed diagnosis of advanced solid tumor.
- Prior failure of a systemic treatment approved by the health authority in the country where the study will be enrolling. Such subjects may also have been treated with radiotherapy, local therapy or surgery.
- Measurable disease using RECIST 1.1 criteria.
- Age ≥ 18 years.
- Select
Exclusion
- Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.
- Subjects who had been treated with ADI-PEG 20 previously.
- History of seizure disorder not related to underlying cancer.
- Known allergy to pegylated compounds.
- Known allergy to E. coli drug products (such as GMCSF).
Key Trial Info
Start Date :
July 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03254732
Start Date
July 14 2017
End Date
February 25 2020
Last Update
April 27 2022
Active Locations (1)
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1
Facility National Cheng Kung University
Tainan, Taiwan, 704