Trial · NCT04738487
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
NCT04738487, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2025-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003). Trials, record NCT04738487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04738487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
- NCT number
- NCT04738487
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,264 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Lung Neoplasms, Non-Small-Cell Lung Carcinoma
- Interventions
- Pembrolizumab/Vibostolimab, Pembrolizumab
- First posted
- 2021-02-04
- Last updated
- 2026-09-17
- Other registries' IDs
- eudract:2020-004049-35
- Results first posted
- 2025-08-26
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | Up to ~39 months | OS was defined as the time from randomization to death due to any cause. |
| Secondary | OS in Participants With PD-L1 TPS ≥1% | Up to ~39 months | OS was defined as the time from randomization to death due to any cause. |
| Secondary | OS in Participants With PD-L1 TPS 1% to 49% | Up to ~39 months | OS was defined as the time from randomization to death due to any cause. |
| Secondary | Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% | Up to ~56 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. 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 is also considered PD. PFS as assessed by blinded independent central review will be presented. |
| Secondary | PFS in Participants With PD-L1 TPS ≥50% | Up to ~56 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. 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 is also considered PD. PFS as assessed by blinded independent central review will be presented. |
| Secondary | PFS in Participants With PD-L1 TPS 1% to 49% | Up to ~56 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. 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 is also considered PD. PFS as assessed by blinded independent central review will be presented. |
| Secondary | Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% | Up to ~56 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. |
| Secondary | ORR in Participants With PD-L1 TPS ≥50% | Up to ~56 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. |
| Secondary | ORR in Participants With PD-L1 TPS 1% to 49% | Up to ~56 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. |
| Secondary | Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% | Up to ~56 months | For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | Up to ~39 months | The analysis population consisted of all participants with PD-L1 TPS ≥ 50% who were randomized prior to the primary completion data cut-off. | Months | MEDIAN |
| SECONDARY | OS in Participants With PD-L1 TPS ≥1% | Up to ~39 months | The analysis population consisted of all participants with PD-L1 TPS ≥ 1% who were randomized prior to the primary completion data cut-off. | Months | MEDIAN |
| SECONDARY | OS in Participants With PD-L1 TPS 1% to 49% | Up to ~39 months | The analysis population consisted of all participants with PD-L1 TPS 1% to 49% who were randomized prior to the primary completion data cut-off. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% | Up to ~56 months | |||
| SECONDARY | PFS in Participants With PD-L1 TPS ≥50% | Up to ~56 months | |||
| SECONDARY | PFS in Participants With PD-L1 TPS 1% to 49% | Up to ~56 months | |||
| SECONDARY | Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% | Up to ~56 months | |||
| SECONDARY | ORR in Participants With PD-L1 TPS ≥50% | Up to ~56 months | |||
| SECONDARY | ORR in Participants With PD-L1 TPS 1% to 49% | Up to ~56 months | |||
| SECONDARY | Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% | Up to ~56 months |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | Pembrolizumab/Vibostolimab | 15.7 | 95% Confidence Interval 12.4 to 24.0 | Months | |
| Overall Survival (OS) in Participants With PD-L1 TPS ≥50% | Pembrolizumab | 20.3 | 95% Confidence Interval 16.7 to 24.2 | Months | |
| OS in Participants With PD-L1 TPS ≥1% | Pembrolizumab/Vibostolimab | 15.0 | 95% Confidence Interval 12.7 to 17.4 | Months | |
| OS in Participants With PD-L1 TPS ≥1% | Pembrolizumab | 16.4 | 95% Confidence Interval 14.9 to 19.1 | Months | |
| OS in Participants With PD-L1 TPS 1% to 49% | Pembrolizumab/Vibostolimab | 14.3 | 95% Confidence Interval 11.3 to 17.8 | Months | |
| OS in Participants With PD-L1 TPS 1% to 49% | Pembrolizumab | 14.3 | 95% Confidence Interval 11.7 to 16.1 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab/Vibostolimab | 594 | |
| Overall Study | STARTED | Pembrolizumab | 612 | |
| Overall Study | Treated | Pembrolizumab/Vibostolimab | 593 | |
| Overall Study | Treated | Pembrolizumab | 610 | |
| Overall Study | Received Pembrolizumab/Vibostolimab (MK-7684A) Second Course | Pembrolizumab/Vibostolimab | 1 | |
| Overall Study | Received Pembrolizumab/Vibostolimab (MK-7684A) Second Course | Pembrolizumab | 0 | |
| Overall Study | Received Pembrolizumab Second Course | Pembrolizumab/Vibostolimab | 0 | |
| Overall Study | Received Pembrolizumab Second Course | Pembrolizumab | 3 | |
| Overall Study | COMPLETED | Pembrolizumab/Vibostolimab | 0 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,196
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/Vibostolimab First Course | 145 | 593 | 182 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab First Course | 117 | 610 | 162 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab/Vibostolimab Second Course | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 1 | 3 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab/Vibostolimab First Course | 39 | 593 | 50 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab First Course | 29 | 610 | 32 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab/Vibostolimab Second Course | 0 | 1 | 0 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab Second Course | 0 | 3 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab/Vibostolimab First Course | 56 | 593 | 74 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab First Course | 67 | 610 | 78 |
1 to 10 of 1,196Source ClinicalTrials.gov
See all 1,196 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab/Vibostolimab First Course | 291 | 594 |
| Total, all-cause mortality | Pembrolizumab First Course | 310 | 612 |
| Total, all-cause mortality | Pembrolizumab/Vibostolimab Second Course | 0 | 1 |
| Total, all-cause mortality | Pembrolizumab Second Course | 0 | 3 |
| Total, other adverse events | Pembrolizumab/Vibostolimab First Course | 478 | 593 |
| Total, other adverse events | Pembrolizumab First Course | 472 | 610 |
| Total, other adverse events | Pembrolizumab/Vibostolimab Second Course | 1 | 1 |
| Total, other adverse events | Pembrolizumab Second Course | 2 | 3 |
| Total, serious adverse events | Pembrolizumab/Vibostolimab First Course | 249 | 593 |
| Total, serious adverse events | Pembrolizumab First Course | 220 | 610 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04738487
GET https://conductscience.org/api/trials/v1/NCT04738487/registered?page=2