Trial · NCT02899299
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
NCT02899299, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2021-04-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients. Trials, record NCT02899299. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02899299
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
- NCT number
- NCT02899299
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 605 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Mesothelioma
- Interventions
- Nivolumab, Ipilimumab, Pemetrexed, Cisplatin, Carboplatin
- First posted
- 2016-09-14
- Last updated
- 2024-05-21
- Other registries' IDs
- eudract:2016-001859-43
- Results first posted
- 2021-04-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization to the date of death (Up to 40 Months) | Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive. |
| Secondary | Objective Response Rate (ORR) | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months) | Objective Response Rate is defined as the percentage of randomized participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement. |
| Secondary | Disease Control Rate (DCR) | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months | Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. Per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s). |
| Secondary | Progression Free Survival (PFS) | From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months) | Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement. |
| Secondary | Overall Survival (OS) According to PD-L1 Expression Level | From randomization date to the date of death (Up to 76 Months) | PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis. OS was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive. |
| Secondary | Progression Free Survival (PFS) According to PD-L1 Expression Level | From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months) | PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by progression free survival (PFS) analysis. PFS is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement. |
| Secondary | Objective Response Rate (ORR) According to PD-L1 Expression Level | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months) | PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by objective response rate (ORR) analysis. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization to the date of death (Up to 40 Months) | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months) | All Randomized Participants | Percentage of Participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months | All Randomized Participants | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months) | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) According to PD-L1 Expression Level | From randomization date to the date of death (Up to 76 Months) | All PD-L1 evaluable participants with baseline expression \<1% or ≥1% | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) According to PD-L1 Expression Level | From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months) | All PD-L1 evaluable participants with baseline expression \<1% or ≥1% | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) According to PD-L1 Expression Level | From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months) | All PD-L1 evaluable participants with baseline expression \<1% or ≥1% | Percentage of Participants | NUMBER |
| POST_HOC | Extended Collection: Overall Survival (OS) | From randomization date to the date of death (Up to 76 Months) | All Randomized Participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Treatment A | 18.07 | 95% Confidence Interval 16.82 to 21.45 | Months | |
| Overall Survival (OS) | Treatment B | 14.09 | 95% Confidence Interval 12.45 to 16.23 | Months | |
| Objective Response Rate (ORR) | Treatment A | 39.3 | 95% Confidence Interval 33.7 to 45.0 | Percentage of Participants | |
| Objective Response Rate (ORR) | Treatment B | 44.4 | 95% Confidence Interval 38.7 to 50.2 | Percentage of Participants | |
| Disease Control Rate (DCR) | Treatment A | 76.6 | 95% Confidence Interval 71.4 to 81.2 | Percentage of Participants | |
| Disease Control Rate (DCR) | Treatment B | 85.8 | 95% Confidence Interval 81.3 to 89.5 | Percentage of Participants | |
| Progression Free Survival (PFS) | Treatment A | 6.77 | 95% Confidence Interval 5.59 to 7.36 | Months | |
| Progression Free Survival (PFS) | Treatment B | 7.23 | 95% Confidence Interval 6.93 to 8.05 | Months | |
| Overall Survival (OS) According to PD-L1 Expression Level | Treatment A | <1% PD-L1 | 17.3 | 95% Confidence Interval 10.1 to 23.9 | Months |
| Overall Survival (OS) According to PD-L1 Expression Level | Treatment B | <1% PD-L1 | 16.6 | 95% Confidence Interval 13.4 to 20.8 | Months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment | STARTED | Treatment A | 303 | |
| Pre-treatment | STARTED | Treatment B | 302 | |
| Pre-treatment | COMPLETED | Treatment A | 300 | |
| Pre-treatment | COMPLETED | Treatment B | 284 | |
| Pre-treatment | NOT COMPLETED | Treatment A | 3 | |
| Pre-treatment | NOT COMPLETED | Treatment B | 18 | |
| Treatment | STARTED | Treatment A | 300 | |
| Treatment | STARTED | Treatment B | 284 | |
| Treatment | COMPLETED | Treatment A | 0 | |
| Treatment | COMPLETED | Treatment B | 189 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events500
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 | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 41 | 300 | |
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed Plus Cisplatin or Carboplatin | 118 | 284 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 0 | 300 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pemetrexed Plus Cisplatin or Carboplatin | 25 | 284 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 5 | 300 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed Plus Cisplatin or Carboplatin | 79 | 284 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 5 | 300 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pemetrexed Plus Cisplatin or Carboplatin | 32 | 284 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 37 | 300 | |
| other | Hypothyroidism | Endocrine disorders | Pemetrexed Plus Cisplatin or Carboplatin | 3 | 284 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 251 | 303 |
| Total, all-cause mortality | Pemetrexed Plus Cisplatin or Carboplatin | 259 | 302 |
| Total, other adverse events | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 277 | 300 |
| Total, other adverse events | Pemetrexed Plus Cisplatin or Carboplatin | 264 | 284 |
| Total, serious adverse events | Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg | 188 | 300 |
| Total, serious adverse events | Pemetrexed Plus Cisplatin or Carboplatin | 106 | 284 |
Source ClinicalTrials.gov
Papers5
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 |
|---|---|
| Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg vs Pemetrexed Plus Cisplatin or Carboplatin: deaths from any cause | Trial comparisons |
| Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg vs Pemetrexed Plus Cisplatin or Carboplatin: 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/NCT02899299
GET https://conductscience.org/api/trials/v1/NCT02899299/results?page=2