Phase 3
N=176
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT02709512 ↗Enrolled (actual)
176
Serious AEs
15.7%
Results posted
Oct 2023
Primary outcome: Primary: Response Rate — 12; 12 Participants — p=0.9489
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ADI-PEG 20 plus Pem Platinum (Drug); Placebo plus Pem Platinum (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Polaris Group
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
12; 12 | 0.9489 |
| PRIMARY Overall Survival Phase 3 Interim Analysis |
9.82; 7.49 | 0.0078 sig |
| PRIMARY Overall Survival |
9.30; 7.66 | 0.0234 sig |
| SECONDARY Progression Free Survival |
6.24; 5.65 | 0.0193 sig |
Summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
Eligibility Criteria
Inclusion Criteria
- Histologically proven unresectable MPM of biphasic or sarcomatoid histology
- Naïve to chemotherapy or immunotherapy
- ECOG PS 0-1
- Expected survival of at least 3 months
- Age 18 years or over (there is no upper age limit)
- Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
- Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria
- Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
- History of unstable cardiac disease
- Ongoing toxic manifestations of previous treatments
- Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
Data sourced from ClinicalTrials.gov (NCT02709512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.