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Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

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ClinicalTrials.gov Identifier: NCT03254732
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Advanced Solid Cancers Drug: ADI PEG20 Drug: Pembrolizumab Phase 1

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ADI-PEG 20
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
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.
Drug: Pembrolizumab
Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.
Other Name: Keytruda®


Outcome Measures

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 [ Time Frame: 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 :
  1. Number of Participants with PFS with Combination ADI-PEG 20 and Pembro. [ Time Frame: Assessments ever 9 weeks for 12 months ]
    Progression Free Survival determined by RECIST 1.1

  2. Number of Participants with RR with Combination ADI-PEG 20 and Pembro. [ Time Frame: Assessments ever 9 weeks for 12 months ]
    Response Rate determined by RECIST 1.1


Other Outcome Measures:
  1. Overall Survival [ Time Frame: 12 months after end of treatment ]
    Follow-Up by Phone or Clinic Visit


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254732


Contacts
Contact: John Bomalaski, M.D. 858-452-6688 ext 114 jbomalaski@polarispharma.com

Locations
Taiwan
Facility National Cheng Kung University Recruiting
Tainan, Taiwan, 704
Contact: Tsai-Yun Chen, M.D.         
Sponsors and Collaborators
Polaris Group
More Information

Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT03254732     History of Changes
Other Study ID Numbers: POLARIS2016-002
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: November 2016

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents