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 (KEYFORM-008).
Primary Objective:
To compare MK-4280A to physicians choice chemotherapy with respect to PFS per Lugano response criteria by BICR
Secondary Objectives:
- To compare MK-4280A to physicians choice chemotherapy with respect to OS
- To evaluate MK-4280A and physicians choice chemotherapy with respect to
ORR per Lugano response criteria by BICR
- To evaluate MK-4280A and physicians choice chemotherapy with respect to DOR per Lugano response criteria by BICR
- To evaluate the safety and tolerability of MK-4280A
BENDAMUSTINE
Favezelimab (MK4280A)
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Matthew Matasar
- Principal Investigator
- RWJBarnabas Health
- Community Medical Center
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Vantage Point Center
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.