Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polaris Group
• Treatments: Pembrolizumab

Criteria

Select 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.

Select 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).