Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

NCT03254732 | Terminated Phase 1 FDA Drug

• 1 other identifier: POLARIS2016-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Cancers

Outcome Measures

Primary Outcomes (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

  Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding

  Up to 36 months

Secondary Outcomes (2)

• Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.

  Assessments ever 9 weeks for 12 months

• Number of Participants with RR with Combination ADI-PEG 20 and Pembro.

  Assessments ever 9 weeks for 12 months

Other Outcomes (1)

• Overall Survival

  12 months after end of treatment

Study Arms (1)

ADI-PEG 20

EXPERIMENTAL

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; Drug: Pembrolizumab

Interventions

ADI PEG20 DRUG

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.

ADI-PEG 20

Pembrolizumab DRUG

Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

Also known as: Keytruda®

ADI-PEG 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Polaris Group: lead

Study Sites (1)

Facility National Cheng Kung University

Tainan, 704, Taiwan

Location

MeSH Terms

Interventions

ADI PEG20; pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: August 18, 2017
• Study Start: July 14, 2017
• Primary Completion: May 7, 2019
• Study Completion: February 25, 2020
• Last Updated: April 27, 2022

Record last verified: 2020-03

Locations

TW (1)