A Study of MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Malignant Neoplasm

Treatments: Biological: MK-4700; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06894771

MK-4700-001 (Other Identifier)

4700-001

Details and patient eligibility

About

The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a person's body over time when MK-4700 is given alone or with pembrolizumab (MK-3475) in order to find a dose that is safe, tolerated, and may work to treat certain types of cancer.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• Has histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report who have experienced disease progression on or after prior anti-cancer treatments, or been intolerant to, or refused all treatment known to confer clinical benefit
• Has head and neck squamous cell carcinoma (HNSCC), melanoma (cutaneous), non-small cell lung cancer (NSCLC), cervical cancer, triple negative breast cancer (TNBC), urothelial carcinoma (UC), or renal cell carcinoma (RCC; clear cell, papillary)
• If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
• Has normal cardiac function

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

• If HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
• Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids
• Has current pneumonitis/interstitial lung disease
• Has active infection requiring systemic therapy
• Has known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus infection
• Has had an allogeneic tissue/solid organ transplant in the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Arm 1: MK-4700

Experimental group

Description:

Participants receive escalating doses every three weeks (Q3W) of MK-4700 for a maximum of 35 cycles (approximately 2 years; cycles are 21 days in length). Eligible participants enrolled in Arm 1 who experience progressive disease (PD) may cross over to Arm 2 to receive MK-4700 and pembrolizumab combination therapy.

Treatment:

Biological: MK-4700

Arm 2: MK-4700 + Pembrolizumab

Experimental group

Description:

Participants will receive MK-4700 and pembrolizumab Q3W for up to 35 cycles (approximately 2 years) or until PD, death, toxicity, or withdrawal of consent.

Treatment:

Biological: Pembrolizumab

Biological: MK-4700