Clinical trial NCT03254732: Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Official title: Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Cancers
Lead sponsor: Polaris Group
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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).

Primary outcomes:
measure: 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
timeFrame: Up to 36 months
Secondary outcomes:
measure: Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
timeFrame: Assessments ever 9 weeks for 12 months
measure: Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
timeFrame: Assessments ever 9 weeks for 12 months
Other outcomes:
measure: Overall Survival
timeFrame: 12 months after end of treatment
Locations:
city: Tainan
country: Taiwan
facility: Facility National Cheng Kung University
Study officials:
References: