Trial · NCT02709512

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

NCT02709512, Phase 2, Phase 3, Completed, Polaris Group; results first posted 2023-10-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin. Trials, record NCT02709512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709512

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
NCT number: NCT02709512
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 249 participants, actual
Lead sponsor: Polaris Group
Conditions: Mesothelioma
Interventions: ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum
First posted: 2016-03-16
Last updated: 2023-10-04
Results first posted: 2023-10-04
Limitations and caveats: Enrollment stopped early at the recommendation of the DSMB due to interim analysis positive results and because of slow study enrollment related to an evolving treatment landscape for MPM and the COVID-19 pandemic.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate	approximately 18 months	Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).
Primary	Overall Survival Phase 3 Interim Analysis	Approximately 18 months	The primary analysis of OS Phase 3 was performed at the interim analysis. This was performed once 50% of the planned OS events for phase 3 have occurred (ie, 169 of the 338 planned OS events). This interim analysis will evaluate OS in the ITT population in an unblinded manner. The OS data at the second interim analysis will be analyzed to support the following decisions: Futility stopping: Terminate the study due to futility at the interim analysis. Sample size re-estimation: Increase the target number of OS events after the second interim analysis.. The treatment effect on OS will be evaluated using the stratified log-rank test (stratified by tumor histology).
Primary	Overall Survival	18 months	Overall survival is defined as the time from randomization until death. In the event that no death was documented prior to study termination or analysis cutoff, OS was censored at the last known date the subject was known to be alive, either through completion of on-study visits or through survival follow-up contact. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The Kaplan-Meier curves were also plotted. A Cox proportional hazard model with an adjustment for tumor histology (biphasic vs sarcomatoid) was used to compute the estimated hazard ratio and two-sided 95% CI. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The significance level to be used in the OS analysis at the final analysis was based on α = 0.04999 (two-sided).
Secondary	Progression Free Survival	approximately 18 months	The key secondary endpoint for the phase 3 portion is PFS, which will be analyzed only if the analysis of OS is statistically significant at the final analysis, with alpha level of 0.05 (two-sided) using the same statistical methodologies as applied to OS.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Response Rate	approximately 18 months	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Survival Phase 3 Interim Analysis	Approximately 18 months	months	MEDIAN
PRIMARY	Overall Survival	18 months	months	MEDIAN
SECONDARY	Progression Free Survival	approximately 18 months	months	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Response Rate	Drug: ADI-PEG 20 Plus Pem Platinum	12		Participants
Response Rate	Drug: Placebo Plus Pem Platinum	12		Participants
Overall Survival Phase 3 Interim Analysis	Drug: ADI-PEG 20 Plus Pem Platinum	9.82	95% Confidence Interval 7.85 to 12.91	months
Overall Survival Phase 3 Interim Analysis	Drug: Placebo Plus Pem Platinum	7.49	95% Confidence Interval 5.88 to 9.46	months
Overall Survival	Drug: ADI-PEG 20 Plus Pem Platinum	9.30	95% Confidence Interval 7.85 to 11.79	months
Overall Survival	Drug: Placebo Plus Pem Platinum	7.66	95% Confidence Interval 6.14 to 9.53	months
Progression Free Survival	Drug: ADI-PEG 20 Plus Pem Platinum	6.24	95% Confidence Interval 5.78 to 7.43	months
Progression Free Survival	Drug: Placebo Plus Pem Platinum	5.65	95% Confidence Interval 4.14 to 5.91	months

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 2	STARTED	Drug: ADI-PEG 20 Plus Pem Platinum	87
Phase 2	STARTED	Drug: Placebo Plus Pem Platinum	89
Phase 2	COMPLETED	Drug: ADI-PEG 20 Plus Pem Platinum	87
Phase 2	COMPLETED	Drug: Placebo Plus Pem Platinum	89
Phase 2	NOT COMPLETED	Drug: ADI-PEG 20 Plus Pem Platinum	0
Phase 2	NOT COMPLETED	Drug: Placebo Plus Pem Platinum	0
Phase 3	STARTED	Drug: ADI-PEG 20 Plus Pem Platinum	125
Phase 3	STARTED	Drug: Placebo Plus Pem Platinum	124
Phase 3	COMPLETED	Drug: ADI-PEG 20 Plus Pem Platinum	125
Phase 3	COMPLETED	Drug: Placebo Plus Pem Platinum	124

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Drug: ADI-PEG 20 Plus Pem Platinum	65	125	106
other	Nausea	Gastrointestinal disorders	Drug: Placebo Plus Pem Platinum	67	124	111
other	Fatigue	General disorders	Drug: ADI-PEG 20 Plus Pem Platinum	66	125	106
other	Fatigue	General disorders	Drug: Placebo Plus Pem Platinum	62	124	111
other	Constipation	Gastrointestinal disorders	Drug: ADI-PEG 20 Plus Pem Platinum	54	125	106
other	Constipation	Gastrointestinal disorders	Drug: Placebo Plus Pem Platinum	41	124	111
other	Anemia	Blood and lymphatic system disorders	Drug: ADI-PEG 20 Plus Pem Platinum	34	125	106
other	Anemia	Blood and lymphatic system disorders	Drug: Placebo Plus Pem Platinum	38	124	111
other	Decreased Appetite	Metabolism and nutrition disorders	Drug: ADI-PEG 20 Plus Pem Platinum	26	125	106
other	Decreased Appetite	Metabolism and nutrition disorders	Drug: Placebo Plus Pem Platinum	44	124	111

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Drug: ADI-PEG 20 Plus Pem Platinum	62	125
Total, all-cause mortality	Drug: Placebo Plus Pem Platinum	61	124
Total, other adverse events	Drug: ADI-PEG 20 Plus Pem Platinum	106	125
Total, other adverse events	Drug: Placebo Plus Pem Platinum	111	124
Total, serious adverse events	Drug: ADI-PEG 20 Plus Pem Platinum	19	125
Total, serious adverse events	Drug: Placebo Plus Pem Platinum	20	124

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33358660	DERIVED	PubMed
34589965	DERIVED	PubMed
38358753	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: Response Rate	Trial comparisons
Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: deaths from any cause	Trial comparisons
Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02709512

GET https://conductscience.org/api/trials/v1/NCT02709512/events?page=2

API reference For AI assistants