Last updated on November 2019

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


Brief description of study

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) infuison. 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-nave triple-negative breast cancer (TNBC) or with anti-PD-1/PD-L1 treatment-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).

Detailed Study 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, with Protocol Amendment 06 (dated 23 Aug 2019), 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.

Clinical Study Identifier: NCT03010176

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