Trial · NCT02853331
Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
NCT02853331, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426). Trials, record NCT02853331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02853331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
- NCT number
- NCT02853331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 861 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Renal Cell Carcinoma
- Interventions
- Pembrolizumab, Axitinib, Sunitinib
- First posted
- 2016-08-02
- Last updated
- 2026-02-02
- Other registries' IDs
- eudract:2016-000588-17
- Results first posted
- 2019-11-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented. |
| Primary | Overall Survival (OS) | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented. |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR is presented. |
| Secondary | Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The DCR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR, PR, or SD is presented. |
| Secondary | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. 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. The number of participants who experienced at least one AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Drug Due to an AE | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. 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. The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants | Month 12 | The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 12 is presented. |
| Secondary | Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants | Month 18 | The PFS rate was determined in all participants at Month 18. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 18 is presented. |
| Secondary | Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants | Month 24 | The PFS rate was determined in all participants at Month 24. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes17
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all randomized participants. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all randomized participants. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all randomized participants who experienced a PR, CR or SD for ≥6 months. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all randomized participants who experienced a CR or PR. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Drug Due to an AE | Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months) | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants | Month 12 | The analysis population consisted of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants | Month 18 | The analysis population consisted of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants | Month 24 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group28
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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Pembrolizumab + Axitinib | 15.1 | 95% Confidence Interval 12.6 to 17.7 | Months | |
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Sunitinib | 11.0 | 95% Confidence Interval 8.7 to 12.5 | Months | |
| Overall Survival (OS) | Pembrolizumab + Axitinib | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Sunitinib | NA | 95% Confidence Interval NA to NA | Months | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Pembrolizumab + Axitinib | 59.3 | 95% Confidence Interval 54.5 to 63.9 | Percentage of participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Sunitinib | 35.7 | 95% Confidence Interval 31.1 to 40.4 | Percentage of participants | |
| Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Pembrolizumab + Axitinib | 71.5 | 95% Confidence Interval 67.0 to 75.7 | Percentage of participants | |
| Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Sunitinib | 60.6 | 95% Confidence Interval 55.8 to 65.3 | Percentage of participants | |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Pembrolizumab + Axitinib | NA | Full Range 1.4 to NA | Months | |
| Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review | Sunitinib | 15.2 | Full Range 1.1 to NA | Months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 + Axitinib | 432 | |
| Overall Study | STARTED | Sunitinib | 429 | |
| Overall Study | Treated | Pembrolizumab + Axitinib | 429 | |
| Overall Study | Treated | Sunitinib | 425 | |
| Overall Study | COMPLETED | Pembrolizumab + Axitinib | 0 | |
| Overall Study | COMPLETED | Sunitinib | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Axitinib | 432 | |
| Overall Study | NOT COMPLETED | Sunitinib | 429 |
Source ClinicalTrials.gov
Adverse events602
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 + Axitinib | 32 | 429 | 34 |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 97 | 425 | 152 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + Axitinib | 6 | 429 | 11 |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 41 | 425 | 79 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Axitinib | 8 | 429 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 82 | 425 | 152 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab + Axitinib | 11 | 429 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 95 | 425 | 164 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab + Axitinib | 53 | 429 | 58 |
| other | Hyperthyroidism | Endocrine disorders | Sunitinib | 16 | 425 | 18 |
1 to 10 of 602Source ClinicalTrials.gov
See all 602 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Axitinib | 59 | 432 |
| Total, all-cause mortality | Sunitinib | 97 | 429 |
| Total, other adverse events | Pembrolizumab + Axitinib | 417 | 429 |
| Total, other adverse events | Sunitinib | 415 | 425 |
| Total, serious adverse events | Pembrolizumab + Axitinib | 173 | 429 |
| Total, serious adverse events | Sunitinib | 133 | 425 |
Source ClinicalTrials.gov
Papers10
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab + Axitinib vs Sunitinib: Number of Participants Who Discontinued Study Drug Due to an AE | Trial comparisons |
| Pembrolizumab + Axitinib vs Sunitinib: Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab + Axitinib vs Sunitinib: deaths from any cause | Trial comparisons |
| Pembrolizumab + Axitinib vs Sunitinib: 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/NCT02853331
GET https://conductscience.org/api/trials/v1/NCT02853331/results?page=2