Clinical trial · Interventional
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
Phase 1B Study of ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers
NCT03254732CI-TRIAL-00058096terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Changing Corporate Priorities
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Cancers | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADI PEG20 | Drug | Pegargiminase | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADI-PEG 20
- description
- 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.
- interventionNames
- Drug: ADI PEG20
- Drug: Pembrolizumab
Primary outcomes (1)
- 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
- description
- Number of participants with treatment-related adverse events and severity this is graded by CTCAE and MedDRA for Coding
Secondary outcomes (2)
- measure
- Number of Participants with PFS with Combination ADI-PEG 20 and Pembro.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.