MK-3475 vs MK-3475+Sacituzumab Govitecan in PD-L1 TPS ≥50% mNSCLC
Research type
Research Study
Full title
An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator-Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTE D46/EVOKE-03)
IRAS ID
1006501
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2022-000836-49
Clinicaltrials.gov Identifier
Research summary
Non-small cell lung cancer (NSCLC) represents approximately 85% of all lung cancers. In the US, a majority of those cancers are not treatable with surgery, and for metastatic disease, have a relatively low 5-year relative survival.
This trial is testing whether Pembrolizumab (MK-3475) taken with or without Sacituzumab Govitecan (SG), is effective in the treatment of adults with a specific severity score for progression of metastatic NSCL (mNSCL). The trial will monitor safety aspects and see if people live longer when given Pembrolizumab alone or with SG.
Approximately 614 eligible male and female participants aged 18 years and over will take part in this trial. Following a screening period of up to 28 days, eligible participants will be randomly put into 1 of 2 treatment groups; Group 1 will receive Pembrolizumab with SG, whilst Group 2 receive Pembrolizumab alone. Administration of both drugs is via intravenous infusion. Pembrolizumab is given once every 3 weeks and SG is given twice every 3 weeks.
The treatment period is dependent on a participant’s health and how well the drugs are tolerated but is expected to last a maximum of 105 weeks, with the participant visiting the site 70 times.
After the treatment period, participants will enter a post-treatment follow up period and will complete a site visit 4 weeks later. Additional follow-up visits will then occur about every 9 to 12 weeks, unless cancer worsens or other cancer treatments commence. Further contact by telephone will then occur about every 12 weeks to check health and treatment status.The Sponsor estimates that the trial will run for 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 LLC., a subsidiary of Merck & Co., Inc. (MSD).
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0207
Date of REC Opinion
14 Dec 2022
REC opinion
Further Information Favourable Opinion