Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Advanced Solid Cancers Clinical Trial

Official title:

Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03254732
• Other study ID #: POLARIS2016-002
• Status: Terminated
• Phase: Phase 1
• Start date: July 14, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2020
• Source: Polaris Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: February 25, 2020
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Solid Cancers

Intervention

Drug:
• ADI PEG20
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.
• Pembrolizumab
Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.

Locations

Country	Name	City	State
Taiwan	Facility National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Polaris Group

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	Follow-Up by Phone or Clinic Visit	12 months after end of treatment
Primary	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	Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.	Progression Free Survival determined by RECIST 1.1	Assessments ever 9 weeks for 12 months
Secondary	Number of Participants with RR with Combination ADI-PEG 20 and Pembro.	Response Rate determined by RECIST 1.1	Assessments ever 9 weeks for 12 months