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 - MK-4280 and Pembrolizumab in Hematologic Malignancies

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites84 target enrollmentFebruary 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 1, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

•1Have meas disease,def as at least1lesion can be accurat measured in2dimens with diagn quality cross sectional anat imaging(CTorMRI).Min meas must be\>15mm in the longest diameter or\>10mm in the short axis
•2Be able to provide a core or excisional tum biopsy fr biomarker analysis from an arch or newly obtained biopsy(within3months)at Screening
•PD1/L1Naive R/RcHL(C.1\)
•3Have histol conf clas Hodgkin lymph
•4Have relapse (def as disease progr after most recent ther)or refractory (def as failure to achieveCRorPRto most recent ther)cHL and meet at least1of the incl:
•aHave failed to achieve a resp or progres after autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved post autoSCT
•bWere unable to achieve aCRorPR to salvage chemot and did not receive autoSCT.Must have relapsed after treatm with or failed to resp to brentuximab ved
•cPts who are ineleg fr brentuximab ved, who discontinued brentit ved due to tox, or who reside in a region where brentuximab is not appr or available are eligib fr the stud
•5Havenot prev been treated with antiPD1or antiPDL1ther
•PD1/L1Refractory R/R cHL(C.2\)

•1Has known clinically active central nervous system involvement
•2A WOCBP who has a positive urine pregnancy test within 72hours prior to study intervention allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
•3Has known clinically significant heart disease
•4Has received prior therapy with an antiLAG3 antibody
•5Has received CAR\-T cells therapy
•6Cohort 1: Has received prior therapy with an antiPD1 or antiPDL1 antibody
•7Cohorts 2, 3, 4: Has severe hypersensitivity (\=Grade3\) to pembrolizumab and/or any of its excipients
•8Has received prior anticancer therapy or thoracic radiation therapy within14days before the first dose of study intervention
•9Grade2or higher nonhematological toxicities from prior therapy.Residual toxicity of Grade 1from prior therapy or persistent treatment\-related Grade 1 neurotoxicity will be allowed
•10Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (ie, \=Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier