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Completed

NCT Number: 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)

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

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Key information

Conditions

Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Oncología e Investigación de Buenos Aires ( Site 0203), Berazategui, Buenos Aires, Argentina

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About this study

Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion criteria

  • A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
  • Has not received prior systemic treatment for metastatic NSCLC
  • Has measurable disease based on RECIST 1.1, as determined by the local site assessment
  • Has a life expectancy of at least 3 months
  • Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method

Exclusion criteria

  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
  • Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
  • Received prior systemic anticancer therapy for metastatic disease
  • Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
  • History of allogeneic tissue/solid organ transplant
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation
  • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention

Treatment and study plan

Pembrolizumab/Vibostolimab

Biological

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

Other names: MK-7684A

carboplatin

Drug

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

Other names: PARAPLATIN®, Paraplatin NovaPlus ®

Cisplatin

Drug

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

Other names: Platinol-AQ®

paclitaxel

Drug

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

Other names: TAXOL®, ONXOL®

Nab-paclitaxel

Drug

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

Other names: ABRAXANE®

Pemetrexed

Drug

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

Other names: Alimta®

Pembrolizumab

Biological

Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Other names: MK-3475, KEYTRUDA®

Primary outcomes

  1. Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

    Time frame: 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 outcomes

  1. Overall Survival (OS) in All Participants

    Time frame: 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.

  2. Progression-Free Survival (PFS)

    Time frame: 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.

  3. Objective Response Rate (ORR)

    Time frame: 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.

  4. Duration of Response (DOR)

    Time frame: 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.

  5. 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)

    Time frame: 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.

  6. Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

    Time frame: 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.

  7. Change From Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    Time frame: 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.

  8. Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    Time frame: 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.

  9. 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)

    Time frame: 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.

  10. Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13

    Time frame: Baseline and Up to approximately 29 months

    Change from baseline in the score of EORTC QLQ-LC13 Item 40 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 had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.

  11. Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30

    Time frame: Up to approximately 29 months

    TTD 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. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  12. TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30

    Time frame: Up to approximately 29 months

    TTD 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. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  13. TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

    Time frame: Up to approximately 29 months

    TTD 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. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  14. TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

    Time frame: Up to approximately 29 months

    TTD 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. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  15. TTD in Cough Score (Item 31) on the EORTC QLQ-LC13

    Time frame: Up to approximately 29 months

    TTD 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. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  16. TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

    Time frame: Up to approximately 29 months

    TTD in the score of EORTC QLQ-LC13 Item 40 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 had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.

  17. Number of Participants Who Experienced One or More Adverse Events (AEs)

    Time frame: Up to approximately 46 months

    The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

  18. Number of Participants Who Discontinued Study Intervention Due to an AE

    Time frame: Up to approximately 46 months

    The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 7, 2022
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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