Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)
CompletedPhase 2Results postedLast updated 15 August 2025
What this trial tests
Phase 2 trial testing Pembrolizumab/Vibostolimab coformulation in Metastatic Non Small Cell Lung Cancer in 255 participants. Completed in 17 October 2024.
18 and older, any sex, with Metastatic Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) AssessmentPrimary· Up to approximately 21 months
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. 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 ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
5.6
3.9 – 6.8
Arm 2: Pembrolizumab/Vibostolimab Coformulation
2.7
1.8 – 4.0
Arm 3: Placebo + Docetaxel
3.2
2.8 – 5.7
Objective Response Rate (ORR) Per RECIST 1.1 by BICR AssessmentSecondary· Up to approximately 21 months
ORR is defined as the percentage of participants who have a confirmed 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 RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
29.9
20.5 – 40.6
Arm 2: Pembrolizumab/Vibostolimab Coformulation
6.0
2.0 – 13.5
Arm 3: Placebo + Docetaxel
15.3
8.4 – 24.7
Overall Survival (OS)Secondary· Up to approximately 21 months
OS is defined as the time from randomization to the date of death due to any cause.
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
10.2
8.6 – 14.9
Arm 2: Pembrolizumab/Vibostolimab Coformulation
7.5
5.2 – 13.4
Arm 3: Placebo + Docetaxel
8.8
6.4 – 11.1
Duration of Response (DOR) Per RECIST 1.1 by BICR AssessmentSecondary· Up to approximately 21 months
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assess
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
6.5
5.3 – 10.7
Arm 2: Pembrolizumab/Vibostolimab Coformulation
NA
2.8 – NA
Arm 3: Placebo + Docetaxel
NA
3.0 – NA
Number of Participants Who Experienced an Adverse Event (AE)Secondary· Up to approximately 39 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is reported here.
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
85
Arm 2: Pembrolizumab/Vibostolimab Coformulation
76
Arm 3: Placebo + Docetaxel
82
Number of Participants Who Discontinued Study Treatment Due to an AESecondary· Up to approximately 27 months
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.
Group
Value
95% CI
Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel
42
Arm 2: Pembrolizumab/Vibostolimab Coformulation
12
Arm 3: Placebo + Docetaxel
24
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 39 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04725188.