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Ph2 Study of MK-3475A in Hematologic Malignances in Participants with Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
EU CTIS ID: 2024-510969-42-00
What this study is testing
1. To characterize the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of MK-3475A (Cycle 1) 2. To evaluate MK-3475A SC by cohort with respect to objective response rate (ORR) as assessed by the investigator according to Lugano classification criteria
- 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
- Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL)
- Radiographically measurable cHL or PMBCL disease assessed by investigator as per Lugano classification
- Has a life expectancy of > 3 months
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if they have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening
You likely can't join if
- Has clinically significant (ie, active) cardiovascular disease.
- Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological therapy not specified in this protocol
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy except certain protocol-specified therapies
See the full eligibility criteria
- Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL)
- Radiographically measurable cHL or PMBCL disease assessed by investigator as per Lugano classification
- Has a life expectancy of > 3 months
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if they have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before or on the day of the first dose of study intervention
- Has clinically significant (ie, active) cardiovascular disease.
- Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological therapy not specified in this protocol
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy except certain protocol-specified therapies
- Concurrent active hepatitis B and hepatitis C virus infection
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplant (SCT) within the last 5 years
- Has pericardial effusion or clinically significant pleural effusion
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier
- Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before first dose of study intervention
The study team makes the final eligibility decision.
Where it's taking place
- United States
- New Zealand
- United Kingdom
- Korea, Republic of
- Mexico
- Chile
- Australia
- Turkey
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; New Zealand; United Kingdom; Korea, Republic of; Mexico; Chile and 2 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.