Trial · NCT04153565
A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)
NCT04153565, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2024-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17). Trials, record NCT04153565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04153565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)
- NCT number
- NCT04153565
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Mesothelioma
- Interventions
- Pembrolizumab, Pemetrexed, Cisplatin
- First posted
- 2019-11-06
- Last updated
- 2025-07-17
- Results first posted
- 2024-03-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 1, Per Common Terminology Criteria for Adverse Events (AEs), Version 5.0 (CTCAE) | Up to 3 weeks (through Cycle 1 [21 days]) | DLTs were assessed during Cycle 1 (21 days) and defined as any of the following, if considered by investigator to be related to any of the study interventions: Grade 4 hematologic toxicities, except neutropenia and febrile neutropenia; Grade 4 neutropenia lasting \>7 days despite appropriate supportive treatment; Grade 4 febrile neutropenia only if the event considered as clinically significant by investigator and sponsor; any Grade 4 non-hematologic toxicity (except laboratory test abnormal including transient electrolyte abnormalities); any Grade 3 non-hematologic toxicity lasting \>72 hours despite appropriate supportive treatment (not laboratory); and any Grade 4 laboratory test value abnormality; any Grade 3 laboratory test value abnormality lasting \>7 days; delay in start of second course of more than 2 weeks (more than 35 days after the first dose) due to toxicity related to study procedures; any Grade 5 toxicity. |
| Primary | Number of Participants With One or More Adverse Events (AEs) | Up to approximately 34 months | An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. |
| Primary | Number of Participants Discontinuing Study Treatment Due to an AE | Up to approximately 2 years | An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 31 months | ORR was defined as the percentage of participants who have a Complete Response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). ORR was based on modified Response Evaluation Criteria In Solid Tumors (RECIST) for Malignant Pleural Mesothelioma (MPM) as assessed by investigator. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 31 months | DCR was defined as the percentage of participants who had a Complete Response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\]) DCR was based on modified RECIST for MPM as assessed by investigator. |
| Secondary | Duration of Response (DOR) | Up to approximately 31 months | For participants who demonstrate a confirmed complete response (CR: disappearance of target and non-target lesions and normalization of tumor markers) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was based on modified RECIST for MPM as assessed by investigator. |
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 | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 1, Per Common Terminology Criteria for Adverse Events (AEs), Version 5.0 (CTCAE) | Up to 3 weeks (through Cycle 1 [21 days]) | All participants who received at least 1 dose of study intervention and who met the criteria for DLT evaluability by finishing Cycle 1 without a DLT or having experienced a DLT | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With One or More Adverse Events (AEs) | Up to approximately 34 months | All participants who received at least 1 dose of study intervention | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Discontinuing Study Treatment Due to an AE | Up to approximately 2 years | All participants who received at least 1 dose of study intervention | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 31 months | All participants who received at least 1 dose of study intervention | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Up to approximately 31 months | All participants who received at least 1 dose of study intervention | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 31 months | All participants who received at least 1 dose of study intervention and demonstrated a confirmed response (CR or PR) | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 1, Per Common Terminology Criteria for Adverse Events (AEs), Version 5.0 (CTCAE) | Pembrolizumab + Pemetrexed + Cisplatin | 2 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Pembrolizumab + Pemetrexed + Cisplatin | 19 | Participants | ||
| Number of Participants Discontinuing Study Treatment Due to an AE | Pembrolizumab + Pemetrexed + Cisplatin | 6 | Participants | ||
| Objective Response Rate (ORR) | Pembrolizumab + Pemetrexed + Cisplatin | 73.7 | 95% Confidence Interval 48.8 to 90.9 | Percentage of participants | |
| Disease Control Rate (DCR) | Pembrolizumab + Pemetrexed + Cisplatin | 94.7 | 95% Confidence Interval 74.0 to 99.9 | Percentage of participants | |
| Duration of Response (DOR) | Pembrolizumab + Pemetrexed + Cisplatin | 16.8 | Full Range 3.0 to NA | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab + Pemetrexed + Cisplatin | 19 | |
| Overall Study | COMPLETED | Pembrolizumab + Pemetrexed + Cisplatin | 6 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Pemetrexed + Cisplatin | 13 |
Source ClinicalTrials.gov
Adverse events70
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 | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Cisplatin | 11 | 19 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Cisplatin | 1 | 19 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Cisplatin | 1 | 19 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Pemetrexed + Cisplatin | 6 | 19 | 13 |
| other | Atrial fibrillation | Cardiac disorders | Pembrolizumab + Pemetrexed + Cisplatin | 1 | 19 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Pembrolizumab + Pemetrexed + Cisplatin | 1 | 19 | 1 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab + Pemetrexed + Cisplatin | 2 | 19 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | Pembrolizumab + Pemetrexed + Cisplatin | 1 | 19 | 1 |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab + Pemetrexed + Cisplatin | 13 | 19 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Pembrolizumab + Pemetrexed + Cisplatin | 10 | 19 | 12 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Pemetrexed + Cisplatin | 13 | 19 |
| Total, other adverse events | Pembrolizumab + Pemetrexed + Cisplatin | 19 | 19 |
| Total, serious adverse events | Pembrolizumab + Pemetrexed + Cisplatin | 7 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40407381 | RESULT |
Source 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04153565
GET https://conductscience.org/api/trials/v1/NCT04153565/events?page=2