Hodgkin Lymphoma
Conditions
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Brief summary
Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.
Interventions
BIOLOGICALfavezelimab/pembrolizumab
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
DRUGbendamustine
IV infusion
DRUGgemcitabine
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator | Up to approximately 39 months | PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 39 months | OS is defined as the time from randomization to death due to any cause. |
| Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator | Up to approximately 39 months | ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator. |
| Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator | Up to approximately 39 months | For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. |
| Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 25 months | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented. |
| Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | Up to approximately 24 months | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Israel, Mexico, Poland, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed