Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Phase 1

Terminated

• Conditions: Advanced Solid Cancers
• Interventions: Drug: ADI PEG20; Drug: Pembrolizumab

• Registration Number: NCT03254732
• Lead Sponsor: Polaris Group

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 combination

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 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-23
• Study Start: 2017-07-14
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Primary Completion: 2019-05-07
• Study Completion: 2020-02-25
• Status Verified: 2020-03
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion 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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADI-PEG 20	ADI PEG20	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.
ADI-PEG 20	Pembrolizumab	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 36 months	Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding

Secondary Outcome Measures

Name	Time	Method
Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.	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.	Assessments ever 9 weeks for 12 months	Response Rate determined by RECIST 1.1

Trial Locations

Locations (1)

Facility National Cheng Kung University; 🇨🇳 Tainan, Taiwan