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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2025-11-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: MK-4700

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.

Group Type EXPERIMENTAL

MK-4700

Intervention Type BIOLOGICAL

Administered via subcutaneous (SC) injection

Arm 2: MK-4700 + Pembrolizumab

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.

Group Type EXPERIMENTAL

MK-4700

Intervention Type BIOLOGICAL

Administered via subcutaneous (SC) injection

Pembrolizumab

Intervention Type BIOLOGICAL

Administered via intravenous infusion

Interventions

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MK-4700

Administered via subcutaneous (SC) injection

Intervention Type BIOLOGICAL

Pembrolizumab

Administered via intravenous infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-3475 KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No