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Active, not recruitingNCT05224141Updated Jul 8, 2025Results posted

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

A Phase 3 interventional study of Pembrolizumab/Vibostolimab Co-Formulation and Saline placebo in Small Cell Lung Carcinoma, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 140 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Read the detailed description

With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.

Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.

02

Conditions studied

  • Small Cell Lung Carcinoma
03

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.

This study's enrollment of 460 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

  • Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
  • Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
  • Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Has a predicted life expectancy of >3 months

Exclusion criteria

Exclusion Criteria:

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

  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
  • Has received prior treatment for Small Cell Lung Cancer (SCLC)
  • Is expected to require any other form of antineoplastic therapy for SCLC while on study
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has had an allogenic tissue/solid organ transplant
  • Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
  • Has symptomatic ascites or pleural effusion
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
460 participants (actual)

Study arms

  • Experimental
    Pembrolizumab/Vibostolimab

    Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

    Biological: Pembrolizumab/Vibostolimab Co-Formulation · Drug: Saline placebo · Drug: Etoposide · Drug: Cisplatin · Drug: Carboplatin

  • Active comparator
    Atezolizumab

    Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

    Drug: Saline placebo · Drug: Etoposide · Drug: Cisplatin · Biological: Atezolizumab · Drug: Carboplatin

Interventions

  • BiologicalPembrolizumab/Vibostolimab Co-Formulation

    Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

    Also known as: MK-7684A

  • DrugSaline placebo

    Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

  • DrugEtoposide

    Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

  • DrugCisplatin

    Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

    Also known as: PLATINOL-AQ®

  • BiologicalAtezolizumab

    Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

    Also known as: TECENTRIQ®

  • DrugCarboplatin

    Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

    Also known as: PARAPLATIN®

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS)

    Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

    Time frame: Up to approximately 25 months

Secondary outcomes

  1. Progression-Free Survival (PFS)

    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. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.

    Time frame: Up to approximately 25 months

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No).

    Time frame: Up to approximately 25 months

  3. Duration of Response (DOR)

    For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data.

    Time frame: Up to approximately 25 months

  4. Percentage of Participants Who Experienced an Adverse Event (AE)

    An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Time frame: Up to approximately 60 months

  5. Percentage of Participants Who Discontinued Study Treatment Due to an AE

    An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Time frame: Up to approximately 60 months

  6. 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)

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-C30 is a cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-C30 is a cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

  9. Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    EORTC QLQ-LC13 is a lung cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-C30 is a cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-C30 is a cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

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

    The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

    Time frame: Baseline and up to approximately 60 months

07

Results

Posted May 30, 2025

Participant flow

Participant flow — Overall Study
MilestonePembrolizumab/VibostolimabAtezolizumab
Started230230
Treated229229
Completed00
Not completed230230
Withdrew: Ongoing7588
Withdrew: Withdrawal by subject24
Withdrew: Death153138

Outcome measures

PrimaryOverall Survival (OS)

Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

Time frame:
Up to approximately 25 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsPembrolizumab/VibostolimabAtezolizumab
Overall Survival (OS)11.5 (9.8 to 12.6)12.9 (11.6 to 14.8)
Statistical analysis
  • Pembrolizumab/Vibostolimab vs Atezolizumab · Log Rank · p = 0.9762 · Hazard ratio (hr): 1.26 · 95% CI 1.00 to 1.59Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).
SecondaryProgression-Free Survival (PFS)

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. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.

Time frame:
Up to approximately 25 months
Reported as:
Median · Months
Progression-Free Survival (PFS)
MonthsPembrolizumab/VibostolimabAtezolizumab
Progression-Free Survival (PFS)5.3 (4.4 to 5.4)4.5 (4.4 to 5.3)
Statistical analysis
  • Pembrolizumab/Vibostolimab vs Atezolizumab · Log Rank · p = 0.5316 · Hazard ratio (hr): 1.01 · 95% CI 0.82 to 1.23Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).
SecondaryObjective Response Rate (ORR)

ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen \& Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No).

Time frame:
Up to approximately 25 months
Reported as:
Number · Percentage of Participants
Objective Response Rate (ORR)
Percentage of ParticipantsPembrolizumab/VibostolimabAtezolizumab
Objective Response Rate (ORR)71.7 (65.4 to 77.5)74.8 (68.7 to 80.3)
Statistical analysis
  • Pembrolizumab/Vibostolimab vs Atezolizumab · Percent difference: -3.1 · 95% CI -11.1 to 4.9Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).
SecondaryDuration of Response (DOR)

For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data.

Time frame:
Up to approximately 25 months
Reported as:
Median · Months
Duration of Response (DOR)
MonthsPembrolizumab/VibostolimabAtezolizumab
Duration of Response (DOR)4.2 (4.1 to 4.3)3.9 (3.4 to 4.1)
SecondaryPercentage of Participants Who Experienced an Adverse Event (AE)

An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame:
Up to approximately 60 months

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Discontinued Study Treatment Due to an AE

An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame:
Up to approximately 60 months

Results for this outcome have not been posted.

SecondaryChange 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)

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

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

The EORTC QLQ-C30 is a cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

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

The EORTC QLQ-C30 is a cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

SecondaryChange From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

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

EORTC QLQ-LC13 is a lung cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

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

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

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

The EORTC QLQ-C30 is a cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

SecondaryTTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30

The EORTC QLQ-C30 is a cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

SecondaryTTD in Cough Score (Item 31) on the EORTC QLQ-LC13

The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

SecondaryTTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

Time frame:
Baseline and up to approximately 60 months

Results for this outcome have not been posted.

Adverse events

Collected over Up to approximately 25 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembrolizumab/Vibostolimab155/230 (67.4%)120/229 (52.4%)228/229 (99.6%)
Atezolizumab141/230 (61.3%)96/229 (41.9%)222/229 (96.9%)
Most frequent serious events
Showing 10 of 165
Most frequent serious events
EventPembrolizumab/VibostolimabAtezolizumab
PneumoniaInfections and infestations19/22917/229
Febrile neutropeniaBlood and lymphatic system disorders15/22913/229
AnaemiaBlood and lymphatic system disorders2/2298/229
NeutropeniaBlood and lymphatic system disorders4/2297/229
ThrombocytopeniaBlood and lymphatic system disorders6/2297/229
DeathGeneral disorders6/2291/229
COVID-19Infections and infestations5/2293/229
HyponatraemiaMetabolism and nutrition disorders3/2295/229
Pulmonary embolismRespiratory, thoracic and mediastinal disorders5/2292/229
LeukopeniaBlood and lymphatic system disorders0/2293/229
Most frequent other events
Showing 10 of 51
Most frequent other events
EventPembrolizumab/VibostolimabAtezolizumab
AnaemiaBlood and lymphatic system disorders154/229130/229
NeutropeniaBlood and lymphatic system disorders130/229126/229
LeukopeniaBlood and lymphatic system disorders95/22987/229
AlopeciaSkin and subcutaneous tissue disorders88/22985/229
NauseaGastrointestinal disorders85/22982/229
ThrombocytopeniaBlood and lymphatic system disorders80/22973/229
Decreased appetiteMetabolism and nutrition disorders75/22944/229
ConstipationGastrointestinal disorders60/22968/229
FatigueGeneral disorders58/22951/229
RashSkin and subcutaneous tissue disorders52/22926/229

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Pembrolizumab/VibostolimabAtezolizumabTotal
Mean63.6 ± 8.863.9 ± 8.563.7 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
Female7664140
Male154166320
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
Hispanic or Latino121830
Not Hispanic or Latino213209422
Unknown or Not Reported538
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
American Indian or Alaska Native202
Asian7864142
Native Hawaiian or Other Pacific Islander000
Black or African American202
White135158293
More than one race347
Unknown or Not Reported10414
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
ECOG= 07781158
ECOG= 1153149302
Lactate Dehydrogenase (LDH) Status at Baseline
Lactate Dehydrogenase (LDH) Status at Baseline(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
≤Upper Limit of Normal (ULN)9294186
>Upper Limit of Normal (ULN)138136274
Presence of Liver Metastases at Baseline
Presence of Liver Metastases at Baseline(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
Yes9398191
No137132269
Presence of Brain Metastases at Baseline
Presence of Brain Metastases at Baseline(Participants)Pembrolizumab/VibostolimabAtezolizumabTotal
Yes151530
No215215430
08

Study locations

140 sites
  • Infirmary Cancer Care ( Site 0022)
    Mobile, Alabama 36607, United States
  • Los Angeles Hematology Oncology Medical Group ( Site 0006)
    Los Angeles, California 90017, United States
  • VA West Los Angeles Medical Center ( Site 0004)
    Los Angeles, California 90073, United States
  • Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
    Boca Raton, Florida 33486, United States
  • Fort Wayne Medical Oncology and Hematology ( Site 0013)
    Fort Wayne, Indiana 46804, United States
  • Dana-Farber Cancer Institute ( Site 0018)
    Boston, Massachusetts 02215, United States
  • Cancer and Hematology Centers of Western Michigan ( Site 0001)
    Grand Rapids, Michigan 49503, United States
  • Hattiesburg Clinic Hematology/Oncology ( Site 0003)
    Hattiesburg, Mississippi 39401, United States
  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
    Lancaster, Pennsylvania 17601, United States
  • Blue Ridge Cancer Care ( Site 0015)
    Blacksburg, Virginia 24060, United States
  • University of Virginia Cancer Center ( Site 0019)
    Charlottesville, Virginia 22903, United States
  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
    Mar del Plata, Buenos Aires B7600FZO, Argentina
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
    Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
  • Hospital Provincial del Centenario ( Site 0205)
    Rosario, Santa Fe Province 2002, Argentina
  • Sanatorio Parque ( Site 0202)
    Rosario, Santa Fe Province S2000DVC, Argentina
  • Nepean Hospital ( Site 2700)
    Kingswood, New South Wales 2747, Australia
  • Calvary Mater Newcastle ( Site 2703)
    Waratah, New South Wales 2298, Australia
  • Frankston Hospital-Oncology and Haematology ( Site 2702)
    Frankston, Victoria 3199, Australia
  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
    Melbourne, Victoria 3021, Australia
  • Medizinische Universität Graz ( Site 0504)
    Graz, Styria 8036, Austria
  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
    Linz, Upper Austria 4020, Austria
  • Kepler Universitätsklinikum ( Site 0507)
    Linz, Upper Austria 4021, Austria
  • Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502)
    Vienna, 1140, Austria
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)
    Vienna, 1210, Austria
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
    Kingston, Ontario K7L 2V7, Canada
  • Lakeridge Health ( Site 0102)
    Oshawa, Ontario L1G 2B9, Canada
  • Anhui Cancer Hospital ( Site 2915)
    Hefei, Anhui 230031, China
  • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
    Beijing, Beijing Municipality 100142, China
  • Beijing Peking Union Medical College Hospital ( Site 2921)
    Beijing, Beijing Municipality 100730, China
  • Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
    Fuzhou, Fujian 350014, China
  • Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
    Harbin, Heilongjiang 150000, China
  • Henan Cancer Hospital ( Site 2916)
    Zhengzhou, Henan 450008, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)
    Wuhan, Hubei 430048, China
  • Hubei Cancer Hospital ( Site 2922)
    Wuhan, Hubei 430079, China
  • Hunan Cancer Hospital ( Site 2907)
    Changsha, Hunan 410013, China
  • The First Affiliated Hospital of Soochow University ( Site 2913)
    Suzhou, Jiangsu 215006, China
  • Jilin Cancer Hospital-GCP office ( Site 2909)
    Changchun, Jilin 130000, China
  • The First Hospital of Jilin University ( Site 2914)
    Changchun, Jilin 130021, China
  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
    Xi'an, Shaanxi 710061, China
  • Shanghai Chest Hospital-Oncology department ( Site 2900)
    Shanghai, Shanghai Municipality 200030, China
  • Fudan University Shanghai Cancer Center ( Site 2908)
    Shanghai, Shanghai Municipality 200032, China
  • Sichuan Cancer hospital. ( Site 2923)
    Chengdu, Sichuan 610042, China
  • West China Hospital Sichuan University ( Site 2903)
    Chengdu, Sichuan 611135, China
  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
    Hangzhou, Zhejiang 310016, China
  • Zhejiang Cancer Hospital-Oncology ( Site 2919)
    Hangzhou, Zhejiang 310022, China
  • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
    Oulu, North Ostrobothnia 90220, Finland
  • Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
    Vaasa, Pohjanmaa 65130, Finland
  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
    Turku, Southwest Finland 20520, Finland
  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
    Marseille, Bouches-du-Rhone 13915, France
  • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
    Toulouse, Haute-Garonne 31400, France
  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803)
    Limoges, Haute-Vienne 87042, France
  • Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
    Heidelberg, Baden-Wurttemberg 69126, Germany
  • Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
    Immenhausen, Hesse 34376, Germany
  • Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
    Hanover, Lower Saxony 30625, Germany
  • LungenClinic Grosshansdorf-Onkologie ( Site 0903)
    Großhansdorf, Schleswig-Holstein 22927, Germany
  • SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
    Gera, Thuringia 07548, Germany
  • Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
    Athens, Attica 115 26, Greece
  • Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
    Athens, Attica 11527, Greece
  • Metropolitan Hospital ( Site 1001)
    Athens, Attica 185 47, Greece
  • University General Hospital of Heraklion ( Site 1004)
    Heraklion, Irakleio 71500, Greece
  • European Interbalkan Medical Center ( Site 1000)
    Thessaloniki, 570 01, Greece
  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
    Kecskemét, Bács-Kiskun county 6000, Hungary
  • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
    Győr, Győr-Moson-Sopron 9024, Hungary
  • Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
    Törökbálint, Pest County 2045, Hungary
  • Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
    Kaposvár, Somogy County 7400, Hungary
  • St. James's Hospital ( Site 1200)
    Dublin, D08 E9P6, Ireland
  • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
    Dublin, Dublin 9, Ireland
  • Rambam Health Care Campus-Oncology ( Site 1301)
    Haifa, 3109601, Israel
  • Shaare Zedek Medical Center-Oncology ( Site 1300)
    Jerusalem, 9103102, Israel
  • Sheba Medical Center-ONCOLOGY ( Site 1302)
    Ramat Gan, 5265601, Israel
  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
    Naples, Campania 80131, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
    Milan, Lombardy 20133, Italy
  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
    Rozzano, Milano 20089, Italy
  • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
    Rome, Roma 00144, Italy
  • Aichi Cancer Center ( Site 3016)
    Nagoya, Aichi-ken 464-8681, Japan
  • National Cancer Center Hospital East ( Site 3002)
    Kashiwa, Chiba 277-8577, Japan
  • National Hospital Organization Shikoku Cancer Center ( Site 3012)
    Matsuyama, Ehime 791-0280, Japan
  • Kurume University Hospital ( Site 3014)
    Kurume, Fukuoka 830-0011, Japan
  • National Hospital Organization Hokkaido Cancer Center ( Site 3015)
    Sapporo, Hokkaido 003-0804, Japan
  • Kanazawa University Hospital ( Site 3006)
    Kanazawa, Ishikawa-ken 920-8641, Japan
  • Kanagawa Cancer Center ( Site 3004)
    Yokohama, Kanagawa 241-8515, Japan
  • Sendai Kousei Hospital ( Site 3001)
    Sendai, Miyagi 981-0914, Japan
  • Niigata Cancer Center Hospital ( Site 3005)
    Niigata, Niigata 951-8566, Japan
  • Kansai Medical University Hospital ( Site 3009)
    Hirakata, Osaka 573-1191, Japan
  • Shizuoka Cancer Center ( Site 3007)
    Nakatogari, Shizuoka 411-8777, Japan
  • Cancer Institute Hospital of JFCR ( Site 3003)
    Koto, Tokyo 135-8550, Japan
  • National Hospital Organization Kyushu Medical Center ( Site 3013)
    Fukuoka, 810-8563, Japan
  • Okayama University Hospital ( Site 3011)
    Okayama, 700-8558, Japan
  • Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
    Klaipėda, Klaipedos Miestas 92288, Lithuania
  • National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
    Vilnius, Vilniaus Miestas 08660, Lithuania
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
    Kaunas, LT-50161, Lithuania
  • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
    Guadalajara, Jalisco 44280, Mexico
  • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
    Guadalajara, Jalisco 44680, Mexico
  • Arké SMO S.A. de C.V. ( Site 0401)
    Mexico City, Mexico City 06700, Mexico
  • iCan Oncology Center Centro Medico AVE ( Site 0406)
    Monterrey, Nuevo León 64710, Mexico
  • Centro de Investigacion Clinica de Oaxaca ( Site 0410)
    Oaxaca City, 68020, Mexico
  • Ziekenhuis Rijnstate ( Site 1606)
    Arnhem, Gelderland 6815 AD, Netherlands
  • Maastricht UMC+-Pulmonary disease ( Site 1602)
    Maastricht, Limburg 6229 HX, Netherlands
  • Jeroen Bosch Hospital-Pulmonology ( Site 1605)
    's-Hertogenbosch, North Brabant 5223 GZ, Netherlands

Showing the first 100 of 140 sites across 25 countries.

09

References and documents

Publications

  • Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4. PubMed 39230120 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05224141
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Mar 24, 2022
Primary completion
Jun 4, 2024
Completion
Jun 7, 2027 (estimated)
Results posted
May 30, 2025
Last update
Jul 8, 2025

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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