Study of MK-1454 Alone or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors or Lymphomas (MK-1454-001)

  • STATUS
    Recruiting
  • End date
    Oct 20, 2022
  • participants needed
    235
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 28 April 2021
cancer
immunodeficiency
lymphoma
carcinoma
breast cancer
major surgery
combination chemotherapy
metastasis
liver metastasis
pembrolizumab
chemotherapy regimen
solid tumour
solid tumor
alopecia
antibody therapy
taxane
mk-3475
t-cell lymphoma
metastatic malignant solid tumor

Summary

The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum administered dose (MAD) of MK-1454 alone and of MK-1454 in combination with pembrolizumab (MK-3475) in participants with advanced/metastatic solid tumors or lymphomas in Part 1, and to evaluate the safety and efficacy of MK-1454 via intratumoral (IT) injection in combination with pembrolizumab in selected solid tumors in Part 2.

MK-1454 will be administered IT; pembrolizumab (pembro) will be administered via intravenous (IV) infusion. In Part 1, participants will be allocated to one of three treatment arms: MK-1454 monotherapy (cutaneous/subcutaneous [cut/subcut] lesions), MK-1454+pembro (cut/subcut lesions), or MK-1454+pembro (visceral lesions).

In Part 2, participants with head and neck squamous cell carcinoma (HNSCC) who are anti-programmed cell death-protein 1 or anti-programmed cell death-ligand 1 (anti-PD-1/PD-L1) refractory or with anti-PD-1/PD-L1 treatment (TrT)-nave triple-negative breast cancer (TNBC) or with anti-PD-1/PD-L1 TrT-nave solid tumors with liver metastases/lesions will receive MK-1454 via IT injection at the RP2D determined in Part 1 PLUS pembrolizumab via IV infusion for up 35 cycles (up approximately 2 years).

Description

Participants will receive either MK-1454 monotherapy or MK-1454 in combination with pembrolizumab for up to 35 cycles (approximately 2 years). Participants will undergo at least a 24-hour inpatient observation period following the first dose administration of MK-1454 on Cycle 1 Day 1 in Part 1. For Part 2, the length of the observation period following administration of the first dose of MK-1454 on Cycle 1 Day 1 is at least 8 hours.

Details
Condition Lymphoma, Lymphoproliferative Disorder, Lymphoma, Non-Hodgkin's Lymphoma, Solid Tumors, Solid Neoplasm, Solid Tumour, Lymphoproliferative disorders, lymphomas
Treatment Pembrolizumab, MK-1454
Clinical Study IdentifierNCT03010176
SponsorMerck Sharp & Dohme Corp.
Last Modified on28 April 2021

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