Trial · NCT05226598
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
NCT05226598, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2025-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007). Trials, record NCT05226598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05226598
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
- NCT number
- NCT05226598
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 739 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Interventions
- Pembrolizumab/Vibostolimab, Carboplatin, Cisplatin, Paclitaxel, Nab-paclitaxel, Pemetrexed, Pembrolizumab
- First posted
- 2022-02-07
- Last updated
- 2026-09-11
- Results first posted
- 2025-11-13
- Limitations and caveats
The pre-specified futility criteria were met at the futility analysis before efficacy IA, and the Sponsor decided to discontinue treatment with MK 7684A. No additional efficacy analysis will be conducted. Analyses on secondary efficacy endpoints, specifically PFS, ORR, DOR and patient-reported outcomes (PROs), will not be conducted.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | Up to approximately 29 months | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Overall Survival (OS) in All Participants | Up to approximately 29 months | OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all randomized participants. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 29 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 as assessed by Response Criteria in Solid Tumors Version 1.1 (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 (BICR) was planned to be presented. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 29 months | ORR is defined as the percentage of participants with 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 RECIST 1.1. The percentage of participants who experience CR or PR as assessed by blinded independent central review (BICR) was planned to be presented. |
| Secondary | Duration of Response (DOR) | Up to approximately 29 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 BICR was planned to be presented. |
| Secondary | Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Baseline and Up to approximately 29 months | Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 was planned to be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. |
| Secondary | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and Up to approximately 29 months | Change from baseline in the score of EORTC QLQ-C30 Items 1-5 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. |
| Secondary | Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 29 months | Change from baseline in the score of EORTC QLQ-C30 Items 6-7 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. |
| Secondary | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and Up to approximately 29 months | Change from baseline in the score of EORTC QLQ-C30 Item 8 was planned to be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. |
| Secondary | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) | Baseline and Up to approximately 29 months | Change from baseline in the score of EORTC QLQ-LC13 Item 31 was planned to be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | Up to approximately 29 months | The analysis population includes all randomized participants with PD-L1 TPS≥1%. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in All Participants | Up to approximately 29 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned PFS data are unavailable. | ||
| SECONDARY | Objective Response Rate (ORR) | Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ORR data are unavailable. | ||
| SECONDARY | Duration of Response (DOR) | Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned DOR data are unavailable. | ||
| SECONDARY | Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | Baseline and Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned electronic patient-reported outcome (ePRO) data are unavailable. | ||
| SECONDARY | Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | ||
| SECONDARY | Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | ||
| SECONDARY | Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. | ||
| SECONDARY | Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) | Baseline and Up to approximately 29 months | After additional Futility Analysis of OS was performed before the first efficacy analysis, as per the supplemental Statistical Analysis Plan amendment (effective date: September 16, 2025) it was stated that no further efficacy analyses would be performed, so the originally planned ePRO data are unavailable. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group4
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 Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | MK-7684A + Chemotherapy | 19.4 | 95% Confidence Interval 17.2 to 23.9 | Months | |
| Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | Pembrolizumab + Chemotherapy | 23.5 | 95% Confidence Interval 19.6 to NA | Months | |
| Overall Survival (OS) in All Participants | MK-7684A + Chemotherapy | 20.0 | 95% Confidence Interval 17.0 to 22.5 | Months | |
| Overall Survival (OS) in All Participants | Pembrolizumab + Chemotherapy | 19.7 | 95% Confidence Interval 17.5 to 23.4 | Months |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-7684A + Chemotherapy | 366 | |
| Overall Study | STARTED | Pembrolizumab + Chemotherapy | 373 | |
| Overall Study | Treated | MK-7684A + Chemotherapy | 360 | |
| Overall Study | Treated | Pembrolizumab + Chemotherapy | 368 | |
| Overall Study | Transitioned to Pembrolizumab + Chemotherapy | MK-7684A + Chemotherapy | 0 | |
| Overall Study | Transitioned to Pembrolizumab + Chemotherapy | Pembrolizumab + Chemotherapy | 0 | |
| Overall Study | COMPLETED | MK-7684A + Chemotherapy | 0 | |
| Overall Study | COMPLETED | Pembrolizumab + Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | MK-7684A + Chemotherapy | 366 | |
| Overall Study | NOT COMPLETED | Pembrolizumab + Chemotherapy | 373 |
Source ClinicalTrials.gov
Adverse events598
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 | MK-7684A + Chemotherapy | 228 | 360 | 392 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy | 231 | 368 | 368 |
| other | Neutropenia | Blood and lymphatic system disorders | MK-7684A + Chemotherapy | 143 | 360 | 303 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy | 125 | 368 | 319 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-7684A + Chemotherapy | 102 | 360 | 173 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab + Chemotherapy | 101 | 368 | 176 |
| other | Hyperthyroidism | Endocrine disorders | MK-7684A + Chemotherapy | 24 | 360 | 24 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab + Chemotherapy | 21 | 368 | 23 |
| other | Hypothyroidism | Endocrine disorders | MK-7684A + Chemotherapy | 50 | 360 | 59 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab + Chemotherapy | 44 | 368 | 53 |
1 to 10 of 598Source ClinicalTrials.gov
See all 598 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-7684A + Chemotherapy | 190 | 366 |
| Total, all-cause mortality | Pembrolizumab + Chemotherapy | 193 | 373 |
| Total, other adverse events | MK-7684A + Chemotherapy | 349 | 360 |
| Total, other adverse events | Pembrolizumab + Chemotherapy | 352 | 368 |
| Total, serious adverse events | MK-7684A + Chemotherapy | 205 | 360 |
| Total, serious adverse events | Pembrolizumab + Chemotherapy | 180 | 368 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39230120 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MK-7684A + Chemotherapy vs Pembrolizumab + Chemotherapy: deaths from any cause | Trial comparisons |
| MK-7684A + Chemotherapy vs Pembrolizumab + Chemotherapy: 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
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GET https://conductscience.org/api/trials/v1/NCT05226598/events?page=2