Trial · NCT02991482
PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma
NCT02991482, Phase 3, Completed, ETOP IBCSG Partners Foundation; results first posted 2022-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma. Trials, record NCT02991482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02991482
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma
- NCT number
- NCT02991482
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 144 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
- Pleural Mesothelioma Malignant Advanced
- Interventions
- Pembrolizumab, Gemcitabine, Vinorelbine
- First posted
- 2016-12-13
- Last updated
- 2026-08-24
- Other registries' IDs
- eudract:2016-002062-31
- Results first posted
- 2022-02-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by Independent Radiological Review | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test. |
| Secondary | Objective Response Rate by Independent Radiological Review | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | Defined as the best overall response (complete or partial response) across all assessment time-points from randomisation to end of trial treatment, determined by RECIST 1.1 criteria. |
| Secondary | Overall Survival. | Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years). | Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date. |
| Secondary | Time to Treatment Failure. | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | Time from from randomisation to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, refusal and death, by Kaplan Meier method. Censoring will occur at the last follow-up date. |
| Secondary | Percentage of Patients Experienced AEs/SAEs | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | The safety and tolerability of pembrolizumab treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment. |
| Secondary | Progression Free Survival (PFS) Assessed by Investigator | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | Investigator assessed PFS, from the date of randomisation until documented progression or death, if progression is not documented. Censoring occurs at the last tumor assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Assessed by Independent Radiological Review | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | All efficacy evaluations were conducted in the intent-to-treat (ITT) population. | months | MEDIAN |
| SECONDARY | Objective Response Rate by Independent Radiological Review | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival. | Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years). | months | MEDIAN | |
| SECONDARY | Time to Treatment Failure. | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | months | MEDIAN | |
| SECONDARY | Percentage of Patients Experienced AEs/SAEs | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | Safety evaluation was conducted in the as-treated (AT) population: all randomised patients that received at least one dose of trial treatment, with treatment assignments designed according to actual study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) Assessed by Investigator | Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). | months | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Assessed by Independent Radiological Review | Pembrolizumab Arm | 2.5 | 95% Confidence Interval 2.1 to 4.2 | months | |
| Progression Free Survival (PFS) as Assessed by Independent Radiological Review | Standard Chemotherapy Arm | 3.4 | 95% Confidence Interval 2.2 to 4.3 | months | |
| Objective Response Rate by Independent Radiological Review | Pembrolizumab Arm | 21.9 | 95% Confidence Interval 13.1 to 33.1 | percentage of participants | |
| Objective Response Rate by Independent Radiological Review | Standard Chemotherapy Arm | 5.6 | 95% Confidence Interval 1.6 to 13.8 | percentage of participants | |
| Overall Survival. | Pembrolizumab Arm | 10.7 | 95% Confidence Interval 7.6 to 15.0 | months | |
| Overall Survival. | Standard Chemotherapy Arm | 12.4 | 95% Confidence Interval 7.4 to 16.1 | months | |
| Time to Treatment Failure. | Pembrolizumab Arm | 2.8 | 95% Confidence Interval 2.1 to 4.2 | months | |
| Time to Treatment Failure. | Standard Chemotherapy Arm | 2.3 | 95% Confidence Interval 2.1 to 3.9 | months | |
| Percentage of Patients Experienced AEs/SAEs | Pembrolizumab Arm | Experienced any adverse event | 70 | Participants | |
| Percentage of Patients Experienced AEs/SAEs | Standard Chemotherapy Arm | Experienced any adverse event | 65 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab Arm | 73 | |
| Overall Study | STARTED | Standard Chemotherapy Arm | 71 | |
| Overall Study | Crossed-over to Pembrolizumab at Progression | Pembrolizumab Arm | 0 | |
| Overall Study | Crossed-over to Pembrolizumab at Progression | Standard Chemotherapy Arm | 45 | |
| Overall Study | COMPLETED | Pembrolizumab Arm | 8 | |
| Overall Study | COMPLETED | Standard Chemotherapy Arm | 5 | |
| Overall Study | NOT COMPLETED | Pembrolizumab Arm | 65 | |
| Overall Study | NOT COMPLETED | Standard Chemotherapy Arm | 66 |
Source ClinicalTrials.gov
Adverse events146
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 | Fatigue | General disorders | Pembrolizumab Arm | 28 | 72 | |
| other | Fatigue | General disorders | Standard Chemotherapy Arm | 32 | 70 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Pembrolizumab Arm | 20 | 72 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Standard Chemotherapy Arm | 10 | 70 | |
| other | Pain | General disorders | Pembrolizumab Arm | 19 | 72 | |
| other | Pain | General disorders | Standard Chemotherapy Arm | 19 | 70 | |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab Arm | 17 | 72 | |
| other | Constipation | Gastrointestinal disorders | Standard Chemotherapy Arm | 23 | 70 | |
| other | Nausea | Gastrointestinal disorders | Pembrolizumab Arm | 16 | 72 | |
| other | Nausea | Gastrointestinal disorders | Standard Chemotherapy Arm | 24 | 70 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab Arm | 48 | 73 |
| Total, all-cause mortality | Standard Chemotherapy Arm | 44 | 71 |
| Total, other adverse events | Pembrolizumab Arm | 70 | 72 |
| Total, other adverse events | Standard Chemotherapy Arm | 65 | 70 |
| Total, serious adverse events | Pembrolizumab Arm | 25 | 72 |
| Total, serious adverse events | Standard Chemotherapy Arm | 20 | 70 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab Arm vs Standard Chemotherapy Arm: deaths from any cause | Trial comparisons |
| Pembrolizumab Arm vs Standard Chemotherapy Arm: 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.
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/NCT02991482
GET https://conductscience.org/api/trials/v1/NCT02991482/events?page=2