NCT05298423|Active Not RecruitingPhase 3DMCFDA Drug

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)

KEYVIBE-006

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

Merck Sharp & Dohme LLC ClinicalTrials.gov

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8 other identifiers

7684A-006MK-7684A-006KEYVIBE-006jRCT2021220015PHRR230831-0060712022-502752-31-00U1111-1285-36562021-005135-23

Study Type

interventional

Target

611

Locations

25 countries

Sites

160

Timeline

RegisteredMar 2022

StartedMay 2022

CompletionAug 2026

Brief Summary

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

611

participants targeted

Target at P75+ for phase_3

Timeline

3mo left

Started May 2022

Typical duration for phase_3

Geographic Reach

25 countries

160 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Progress93%

May 2022Aug 2026

First Submitted

Initial submission to the registry

March 17, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed

1 month until next milestone

Study Start

First participant enrolled

May 3, 2022

Completed

4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4.3 years

First QC Date

March 17, 2022

Last Update Submit

July 30, 2025

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Programmed Cell Death-1 (PD1, PD-1)Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Experience at Least One Adverse Event (AE)
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 48 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 48 months

Study Arms (2)

pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy

EXPERIMENTAL

For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to \~14 months). Cycles 1-20 are 21-day cycles. As of protocol amendment 4, participants receiving pembrolizumab/vibostolimab must stop ongoing treatment with pembrolizumab/vibostolimab and will be offered the option to transition to post-cCRT durvalumab consolidation therapy, to complete up to 1 year of consolidation immunotherapy.

Biological: pembrolizumab/vibostolimabBiological: durvalumabDrug: cisplatinDrug: pemetrexedDrug: etoposideDrug: carboplatinDrug: paclitaxelRadiation: thoracic radiotherapy

chemotherapy+radiotherapy+durvalumab

ACTIVE COMPARATOR

For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Biological: durvalumabDrug: cisplatinDrug: pemetrexedDrug: etoposideDrug: carboplatinDrug: paclitaxelRadiation: thoracic radiotherapy

Interventions

pembrolizumab/vibostolimabBIOLOGICAL

Administered as an intravenous (IV) infusion

Also known as: MK-7684A

pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy

durvalumabBIOLOGICAL

Administered as an IV infusion

Also known as: IMFINZI®