Pembrolizumab and chemotherapy for newly diagnosed classical Hodgkin Lymphoma
Research type
Research Study
Full title
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)
IRAS ID
1003902
Contact name
Vivienne Liddle
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2021-001244-95
Clinicaltrials.gov Identifier
Research summary
Research Summary:
"TrialSummaries.com - Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical
https://clinicaltrials.gov/study/NCT05008224?term=3475-C11&rank=1&tab=resultsHodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)"Despite progress and although often cured, classical Hodgkin Lymphoma (cHL) patients may experience effects from therapy later on which reduces length and quality of life.
This trial is testing pembrolizumab (pembro) and chemotherapy (chemo) in people with newly diagnosed, early unfavourable or advanced cHL. About 140 male and female participants, aged 18 years or older will take part in this trial.
Pembro (also called KEYTRUDA®) has been approved to treat many types of cancers but has not been approved for use with chemo to treat cHL. This trial is testing the safety of pembro and chemo, to see if it helps participants live longer, how well pembro and chemo is tolerated and if cHL responds to treatment The chemo drugs being used in this trial are standard treatments for people with this type of cancer.
There is a screening phase to see if patients can join the trial lasting about one month.
Participants who join will all get treatment with pembro and chemo. First, participants will receive pembro once every 3 weeks for 9 weeks, followed by AVD chemo once every 2 weeks for 8 weeks. Then, participants will receive either AVD (once every 2 weeks for 8 or 16 weeks) or escBEACOPP chemo (every 3 weeks for 6 or 12 weeks) depending on the results of some of the scans and their age. Finally, participants will receive pembro again once every 6 weeks for 24 weeks. Participants will receive treatment for up to 13 months and will be followed-up every 6-12 weeks or more often.
The Sponsor estimates that the trial will require approximately 6 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
21/LO/0545
Date of REC Opinion
16 Sep 2021
REC opinion
Further Information Favourable Opinion