MK 4280A vs Physician’s Choice Chemotherapy in PD-(L)1-refractory, R/R cHL
Research type
Research Study
Full title
A Phase 3 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma
IRAS ID
1005752
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2022-000371-39
Clinicaltrials.gov Identifier
Research summary
There is no globally accepted standard care after first-line treatment for recurred or relapsed Classic Hodgkin’s Lymphoma (cHL). Compared to sequential administration of pembrolizumab and favezelimab as separate formulations, a single coformulation (MK-4280A) could provide significant benefits; simplified preparation, reduced infusion times & reduction of errors in drug administration.
This trial compares MK-4280A to clinician’s choice chemotherapy in PD-(L)1-refractory, Relapsed or Refractory cHL. MK-4280A is a coformulation of favezelimab in combination with pembrolizumab. MK-4280A is not approved to treat cHL.
About 360 male and female participants, aged at least 18 years will be enrolled in the trial, for up to 5 years.
The trial screening period lasts up to 28 days and determines eligibility. Patients visit the trial site at least once during this period.
After screening, eligible participants are randomised in a 1:1 ratio to one of two treatment arms:
• Arm A: MK-4280A (800 mg favezelimab / 200 mg pembrolizumab). Treatment lasts up to 2 years (max 35 cycles; once every 3 weeks) with visits every week for the first 3 weeks, then every 3 weeks.
• Arm B: Bendamustine 90-120 mg / m2 or Gemcitabine 800 – 1,200 mg / m2. Bendamustine treatment is given for up to 18 weeks on a 3-week cycle, or 24 weeks if on a 4-week cycle with visits on the first and second days of every cycle. Gemcitabine treatment is given for up to 18 weeks with visits to the trial site on the first and eighth days of every cycle.
During the trial, participants undergo procedures such as physical examinations, ECGs, CT and PET scans, bone marrow aspirate/biopsy and blood/urine sample collection. Patients are followed up for up to 5 years after first trial treatment.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0525
Date of REC Opinion
16 Aug 2022
REC opinion
Favourable Opinion