Trial · NCT02784171

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

NCT02784171, Phase 2, Phase 3, Completed, Canadian Cancer Trials Group; results first posted 2024-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma. Trials, record NCT02784171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02784171

On this page

Trial

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

Title: Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
NCT number: NCT02784171
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 520 participants, actual
Lead sponsor: Canadian Cancer Trials Group
Conditions: Mesothelioma
Interventions: Cisplatin, Pemetrexed, Pembrolizumab
First posted: 2016-05-26
Last updated: 2024-12-10
Other registries' IDs: eudract:2016-002286-60
Results first posted: 2024-12-10

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.	PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report).
Primary	Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause	Survival was monitored continuously throughout the study and during follow-up. Patients were evaluated for each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.	Overall survival was defined as time from the day of randomization to death for patients died. For patients still alive at time of data-cutoff for analysis, it was censored at the last day the patients were known alive as the last of all dates .
Secondary	Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.	PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report). The primary analysis for PFS was based on the progression evaluated in this study using mesothelioma-modified RECIST (mRECIST) conducted by blinded independent review (BICR).
Secondary	Phase III: Objective Response Rate	Response was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.	Objective response rate was defined as the proportion of patients with best objective response being complete response (CR) or partial response (PR).

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.		months	MEDIAN
PRIMARY	Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause	Survival was monitored continuously throughout the study and during follow-up. Patients were evaluated for each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.	Intention to treat population.	months	MEDIAN
SECONDARY	Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	PFS was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.		months	MEDIAN
SECONDARY	Phase III: Objective Response Rate	Response was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	Arm A - Cisplatin/Pemetrexed	6.7	95% Confidence Interval 2.7 to 8.4	months
Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	Arm B - Cisplatin/Pemetrexed/Pembrolizumab	6.8	95% Confidence Interval 3.9 to 15	months
Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	Arm C - Pembrolizumab (Phase II Only)	5.26	95% Confidence Interval 2.8 to 11.8	months
Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause	Arm A - Cisplatin/Pemetrexed	16.13	95% Confidence Interval 13.08 to 18.17	months
Phase III: Overall Survival Defined as Time From Randomization to the Date of Death From Any Cause	Arm B - Cisplatin/Pemetrexed/Pembrolizumab	17.28	95% Confidence Interval 14.36 to 21.29	months
Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	Arm A - Cisplatin/Pemetrexed	7.16	95% Confidence Interval 6.83 to 7.69	months
Phase III: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression	Arm B - Cisplatin/Pemetrexed/Pembrolizumab	7.13	95% Confidence Interval 6.93 to 8.12	months
Phase III: Objective Response Rate	Arm A - Cisplatin/Pemetrexed	83		Participants
Phase III: Objective Response Rate	Arm B - Cisplatin/Pemetrexed/Pembrolizumab	138		Participants

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A - Cisplatin/Pemetrexed (Phase II)	21
Overall Study	STARTED	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	19
Overall Study	STARTED	Arm C - Pembrolizumab (Phase II Only)	40
Overall Study	STARTED	Arm A - Cisplatin/Pemetrexed (Phase III)	218
Overall Study	STARTED	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	222
Overall Study	COMPLETED	Arm A - Cisplatin/Pemetrexed (Phase II)	21
Overall Study	COMPLETED	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	19
Overall Study	COMPLETED	Arm C - Pembrolizumab (Phase II Only)	40
Overall Study	COMPLETED	Arm A - Cisplatin/Pemetrexed (Phase III)	218
Overall Study	COMPLETED	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	222

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events1,850

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
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Arm A - Cisplatin/Pemetrexed (Phase II)	0	21
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	0	19
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Arm C - Pembrolizumab (Phase II Only)	0	40
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Arm A - Cisplatin/Pemetrexed (Phase III)	0	218
other	Blood and lymphatic system disorders - Other specify	Blood and lymphatic system disorders	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	1	222
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm A - Cisplatin/Pemetrexed (Phase II)	0	21
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	0	19
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm C - Pembrolizumab (Phase II Only)	0	40
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm A - Cisplatin/Pemetrexed (Phase III)	0	218
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	2	222

1 to 10 of 1,850Source ClinicalTrials.gov

See all 1,850 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A - Cisplatin/Pemetrexed (Phase II)	21	21
Total, all-cause mortality	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	14	19
Total, all-cause mortality	Arm C - Pembrolizumab (Phase II Only)	38	40
Total, all-cause mortality	Arm A - Cisplatin/Pemetrexed (Phase III)	175	218
Total, all-cause mortality	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	167	222
Total, other adverse events	Arm A - Cisplatin/Pemetrexed (Phase II)	20	21
Total, other adverse events	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)	18	19
Total, other adverse events	Arm C - Pembrolizumab (Phase II Only)	38	40
Total, other adverse events	Arm A - Cisplatin/Pemetrexed (Phase III)	200	218
Total, other adverse events	Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)	217	222

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33358660	DERIVED	PubMed
37931632	RESULT	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 comparisons1

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

Comparison
Arm A - Cisplatin/Pemetrexed vs Arm B - Cisplatin/Pemetrexed/Pembrolizumab: Phase III: Objective Response Rate

Source 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/NCT02784171

GET https://conductscience.org/api/trials/v1/NCT02784171/events?page=2

API reference For AI assistants