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MK-4280 and Pembrolizumab in Hematologic Malignancies
EU CTIS ID: 2023-503587-17-00
What this study is testing
1. To determine the safety and tolerability and to establish a preliminary recommended Phase2 dose (RP2D) of MK-4280 when used in combination with pembrolizumab. 2. To determine the safety and tolerability of MK-4280 monotherapy. 3. To determine the safety and tolerability of pembrolizumab monotherapy.
- Phase I and Phase II (Integrated)- Other
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 measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
- Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
You likely can't join if
- Has known clinically active central nervous system (CNS) involvement
- Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active infection requiring intravenous systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
See the full eligibility criteria
- Has measurable disease, defined as ≥1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
- Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
- Has known clinically active central nervous system (CNS) involvement
- Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has an active infection requiring intravenous systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has known, active hepatitis B or hepatitis C infection
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
- Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
- Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
- Has received chimeric antigen receptors (CAR)-T-cell therapy for classical Hodgkin lymphoma (cHL) and diffuse large B-cell lymphoma (DLBCL) Cohorts
- Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
- Has ≥Grade 2 non-hematological residual toxicities from prior therapy
- Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to agents administered ≥4 weeks earlier
- Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed
- Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- United States
- Australia
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 Canada; Israel; United States; Australia. 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.