Clinical Trials List
Protocol NumberPOLARIS2016-002
NCT Number(ClinicalTrials.gov Identfier)NCT03254732
Completed
2017-06-08 - 2019-12-31
Phase I
Terminated1
Phase 1 Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers.
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Trial Applicant
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Sponsor
Polaris Group
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Trial scale
Taiwan Single Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- Wu-Chou Su Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Shang-Hung Chen Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Hui-Jen Tsai Division of Hematology & Oncology
- Kwang-Yu Chang Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- Yan-Shen Shan Division of General Surgery
- 劉奕廷 Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Advanced Solid Cancers
Objectives
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 combination
Test Drug
ADI-PEG20
Active Ingredient
Arginine deiminase conjugated to polyethylene glycol 20,000 mw
Dosage Form
Injection
Dosage
11.5 mg/ml
Endpoints
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
2. Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
Other Outcome Measures:
1. Overall Survival.
1. 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.
Secondary Outcome Measures:
1. Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
2. Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
Other Outcome Measures:
1. Overall Survival.
Inclution Criteria
1. Histologically confirmed diagnosis of advanced solid tumor.
2. 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.
3. Measurable disease using RECIST 1.1 criteria.
4. Age ≥ 18 years.
2. 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.
3. Measurable disease using RECIST 1.1 criteria.
4. Age ≥ 18 years.
Exclusion Criteria
1. 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.
2. Subjects who had been treated with ADI-PEG 20 previously.
3. History of seizure disorder not related to underlying cancer.
4. Known allergy to pegylated compounds.
5. Known allergy to E. coli drug products (such as GMCSF).
2. Subjects who had been treated with ADI-PEG 20 previously.
3. History of seizure disorder not related to underlying cancer.
4. Known allergy to pegylated compounds.
5. Known allergy to E. coli drug products (such as GMCSF).
The Estimated Number of Participants
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Taiwan
76 participants
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Global
6~76 participants
