Ph 3 Study of Chemo with MK-7684A or Atezolizumab in 1st-Line ES-SCLC
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer (KEYVIBE-008)
IRAS ID
1004808
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2021-005034-42
Clinicaltrials.gov Identifier
Research summary
Small Cell Lung Cancer (SCLC) remains a worldwide public health problem as a major cause of cancer death. SCLC is an aggressive cancer of the lung which account for 13% to 17% of all lung cancer cases, worldwide approximately 275,000 patients are diagnosed with SCLC annually.
Despite progress in therapy, there remains an unmet medical need to develop newer more effective therapies for the treatment.
This trial is testing MK-7684A combined with etoposide/platinum chemotherapy followed by MK-7684A compared to atezolizumab combined with etoposide/platinum chemotherapy followed by atezolizumab as first-line treatment for people with extensive-stage small cell lung cancer (ES-SCLC).
MK-7684A is a coformulation of pembrolizumab and MK-7684, this is classified as an experimental drug. Keytruda® (pembrolizumab) has been approved and is indicated for the treatment of patients across several indications and has been evaluated for the treatment of ES-SCLC. Atezolizumab (Tecentriq®) is used as treatment in combination with carboplatin and etoposide for the first-line treatment of adult patients with ES-SCLC. The chemotherapy drugs used in this trial are standard treatments for people with SCLC.
Following a screening period of up to 28 days, approximately 450 eligible male and female participants aged 18 years and over will take part in this trial.
Eligible participants will either receive cycles of etoposide/platinum chemotherapy in combination with MK-7684A followed by MK-7684A until any of the conditions for discontinuation are met or will receive 4 cycles of etoposide/platinum chemotherapy in combination with atezolizumab followed by atezolizumab until any of the conditions for discontinuation are met.
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
West of Scotland REC 1
REC reference
22/WS/0026
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion