Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)
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| ClinicalTrials.gov Identifier: NCT02899299 |
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Recruitment Status :
Completed
First Posted : September 14, 2016
Results First Posted : April 14, 2021
Last Update Posted : July 5, 2023
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Mesothelioma |
| Interventions |
Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin |
| Enrollment | 605 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 605 participants randomized and 584 treated. Of the 21 participants not treated, 12 withdrew consent, 5 no longer met study criteria, 3 requested to discontinue study treatment and one was not reported. |
| Arm/Group Title | Treatment A | Treatment B |
|---|---|---|
 Arm/Group Description |
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W | Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles |
| Period Title: Pre-treatment | ||
| Started [1] | 303 | 302 |
| Completed [2] | 300 | 284 |
| Not Completed | 3 | 18 |
| Reason Not Completed | ||
| Participant request to discontinue study treatment | 0 | 3 |
| Participant withdrew consent | 1 | 11 |
| Participant no longer meets study criteria | 2 | 3 |
| Not reported | 0 | 1 |
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[1]
Started = Randomized
[2]
Completed = Entering treatment
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| Period Title: Treatment | ||
| Started [1] | 300 | 284 |
| Completed [2] | 5 | 0 |
| Not Completed | 295 | 284 |
| Reason Not Completed | ||
| Disease Progression | 182 | 44 |
| Study Drug Toxicity | 59 | 24 |
| Adverse Event unrelated to Study Drug | 12 | 9 |
| Participant request to discontinue Study treatment | 4 | 10 |
| Participant withdrew consent | 6 | 3 |
| Lost to Follow-up | 0 | 1 |
| Maximum Clinical Benefit | 10 | 2 |
| Poor/Non-compliance | 1 | 0 |
| Participant no longer meets Study criteria | 4 | 0 |
| Administrative reason by Sponsor | 2 | 0 |
| Other reasons | 11 | 2 |
| Not reported: Includes participants who achieved max duration of treatment | 4 | 189 |
|
[1]
Started = Entering treatment
[2]
Completed = Continuing treatment
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Baseline Characteristics
| Arm/Group Title | Treatment A | Treatment B | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W | Pemetrexed 500 mg/m^2 + Cisplatin 75 mg/m^2 or Carboplatin 5 AUC up to 6 cycles | Total of all reporting groups | |
| Overall Number of Baseline Participants | 303 | 302 | 605 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 303 participants | 302 participants | 605 participants | |
| 68.7 (8.5) | 67.8 (9.7) | 68.2 (9.1) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 303 participants | 302 participants | 605 participants | |
| Female |
69 22.8%
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69 22.8%
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138 22.8%
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| Male |
234 77.2%
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233 77.2%
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467 77.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 303 participants | 302 participants | 605 participants | |
| Hispanic or Latino |
19 6.3%
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19 6.3%
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38 6.3%
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| Not Hispanic or Latino |
122 40.3%
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136 45.0%
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258 42.6%
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| Unknown or Not Reported |
162 53.5%
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147 48.7%
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309 51.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 303 participants | 302 participants | 605 participants | |
| American Indian or Alaska Native |
2 0.7%
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4 1.3%
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6 1.0%
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| Asian |
26 8.6%
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39 12.9%
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65 10.7%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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| White |
266 87.8%
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250 82.8%
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516 85.3%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
9 3.0%
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9 3.0%
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18 3.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title: | Bristol-Myers Squibb Study Director |
| Organization: | Bristol-Myers Squibb |
| Phone: | Please Email: |
| EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02899299 |
| Other Study ID Numbers: |
CA209-743 2016-001859-43 ( EudraCT Number ) |
| First Submitted: | August 31, 2016 |
| First Posted: | September 14, 2016 |
| Results First Submitted: | March 24, 2021 |
| Results First Posted: | April 14, 2021 |
| Last Update Posted: | July 5, 2023 |