A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLC
Research type
Research Study
Full 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)
IRAS ID
1004685
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2021-004564-94
Clinicaltrials.gov Identifier
Research summary
Despite progress in therapy, there remains a substantial unmet medical need to develop newer more effective therapies for the treatment of patients with non-small cell lung cancer (NSCLC).
This trial is testing MK-7684A plus chemotherapy (chemo) compared to pembrolizumab (pembro) plus chemo in people with NSCLC that has spread to other parts of the body and have not yet been treated for this cancer.
MK-7684A is a coformualtion of MK-7684 and pembro. MK-7684 is an experimental drug. Pembro (also called KEYTRUDA®) has been approved to treat many types of cancers but has not been approved to treat your exact type of NSCLC. The chemo drugs in this trial are standard treatments for people with NSCLC. The type of chemo drugs the participant receives depends on the type of NSCLC – squamous or non-squamous.
About 700 male and female participants, aged 18 years or older will take part in this trial.
There is a screening phase to see if patients can join the trial lasting about one month.
Eligible participants will receive treatment up to a maximum of 2 years, as long as their cancer does not get worse and can tolerate the trial drugs. Participants will receive either MK-7684A or pembro with chemo every 3 weeks for the first 3 months and thereafter, participants will receive MK-7684A or pembro every 3 weeks. Participants may be eligible for up to 1 more year of MK-7684A or pembro during Second Course Treatment.
During the study, participants will undergo procedures such as physical examinations, ECGs, blood/urine samples and scans.
The Sponsor estimates that the trial will require approximately 5 years from the time the first participant agrees to take part until the last trial related contact.
The trial is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0062
Date of REC Opinion
2 Mar 2022
REC opinion
Further Information Favourable Opinion