Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
octobre 2022
juin 2031
03 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Study Coordinator | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704) - 87042 - Limoges - Haute-Vienne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 0707) - 35033 - Rennes - Bretagne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CENTRE LEON BERARD-Medical oncology ( Site 0703) - 69008 - Lyon - Rhone - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706) - 31059 - Toulouse - Haute-Garonne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.