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MK-4280A versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, relapsed/refractory Classical Hodgkin Lymphoma
EU CTIS ID: 2023-503615-14-00
What this study is testing
To compare MK-4280A to physician’s choice chemotherapy with respect to PFS per Lugano response criteria by investigator assessment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- 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.
See the full eligibility 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.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Israel
- Australia
- United States
- Canada
- Korea, Republic of
- Argentina
- Switzerland
- Turkey
- Brazil
- Mexico
- China
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Israel; Australia; United States; Canada; Korea, Republic of and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.