Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible participants will be randomly assigned to one of two treatment arms.
In the Experimental Arm, participants will receive coformulated Favezelimab/Pembrolizumab immunotherapy, which will be administered by intravenous (IV) infusion on Day 1, then every three weeks, for up to 35 infusions.
In the Active Comparator Arm, participants will receive physician's choice of chemotherapy: either Bendamustine or Gemcitabine.
Bendamustine will be given via IV infusion at a dose between 90 and 120mg/m^2 on Day 1 and Day 2 of either a 2- or 4- week cycle for up to 6 cycles.
Gemcitabine will be given by IV infusion at a dose between 800 and 1200 mg/m^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.
Conditions
This trial is treating people with relapsed or refractory classical Hodgkin lymphoma who have progressed on prior treatment with an anti-PD-(L)1 monoclonal antibody
Eligibility
Inclusion
- Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
- Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
- Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
- Submits an archival (<5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
Exclusion
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- History of central nervous system (CNS) metastases or active CNS involvement.
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic treatment.
- History of hemophagocytic lymphohisticytosis.
- Has an active seizure disorder that is not well controlled.
- Has clinically significant (ie, active) cardiovascular disease.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
- Has not adequately recovered from major surgical procedure.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- History of human immunodeficiency virus (HIV).
- Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT05508867 *
- 4280A-008; MK-4280A-008; 2023-503615-14; 2022-000371-39
Trial sponsor
Merck Sharp & Dohme LLC
Scientific 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
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information