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RecruitingLast updated: 8 January 2024

MK-4280-003: This phase I/II trial is evaluating an immunotherapy combination (MK-4280 and Pembrolizumab) in patients with Hodgkin Lymphoma, Non-Hodgkin Lymphoma or B-Cell LymphomaA Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

Clinical summary

Summary

This is a non-randomised trial, including Part A (dose escalation) and Part B (dose expansion) treatment phases. In Part A, patients will be assigned to receive a standard (200mg) dose of Pembrolizumab followed by varying doses (A, B or C) of MK-4280 by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. In Part B, patients will be assigned to groups based on their diagnosis. All patients will receive the standard dose (200mg) of Pembrolizumab followed by the recommended phase II dose of MK-4280 by infusion on Day 1 of each 3-week cycle for up to 35 cycles.

Conditions

This trial is treating patients with Hodgkin Lymphoma, Non-Hodgkin Lymphoma or B-Cell Lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

MK-4280-003

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

Eligibility

Inclusion

  • 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)

Exclusion

  • Has known clinically active central nervous system (CNS) involvement
  • Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
  • Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and 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
  • 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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