Advanced Solid CancersPhase 1NCT03254732
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
A Phase 1 study testing ADI PEG20 and Pembrolizumab in people with Advanced Solid Cancers, run by Polaris Group at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- ADI PEG20 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jul 2017to 25 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Select Inclusion Criteria:
- 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.
Select Exclusion Criteria:
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
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
Read the 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).
- Conditions
- Advanced Solid Cancers
- Being tested
- ADI PEG20, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI PEG20Drug
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.
PembrolizumabDrug
Also called Keytruda®
Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ADI PEG20; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 36 months
Secondary outcomes (2)
Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
Progression Free Survival determined by RECIST 1.1
Measured: Assessments ever 9 weeks for 12 months
Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
Response Rate determined by RECIST 1.1
Measured: Assessments ever 9 weeks for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start14 Jul 2017
- Primary completion7 May 2019
- Study completion25 Feb 2020
Why it stopped: Changing Corporate Priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254732
- Sponsor's protocol ID
- POLARIS2016-002
- Status last verified
- Mar 2020
- First submitted
- 23 Dec 2016
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT03254732
- Acronym / sponsor ID
- POLARIS2016-002
- Conditions
- Advanced Solid Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changing Corporate Priorities
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Drug: ADI PEG20, Drug: PembrolizumabThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI PEG20ADI 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 | ADI-PEG 20 |
| PembrolizumabAlso: Keytruda®Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment. | Drug | ADI-PEG 20 |
Primary outcome
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
2 secondary outcomes
Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
Time frame: Assessments ever 9 weeks for 12 months
Number of Participants with RR with Combination ADI-PEG 20 and Pembro.
Time frame: Assessments ever 9 weeks for 12 months
Results and safety
The study was stopped early (reason given: Changing Corporate Priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI PEG20 and Pembrolizumab in people with Advanced Solid Cancers, run by Polaris Group at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Changing Corporate Priorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.