Clinical trial NCT06894771: A Study of MK-4700 Alone or With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (MK-4700-001)
Official title: A Phase 1 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-4700 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Malignant Neoplasm
Keywords: Head and Neck Squamous Cell Carcinoma
Melanoma
Non-small Cell Lung Cancer
Cervical Cancer
Triple Negative Breast Cancer
Urothelial Carcinoma
Renal Cell Carcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: Cycle 1 (up to 21 days)
measure: Percentage of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 4.5 years
measure: Percentage of Participants who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 4.5 years
Secondary outcomes:
measure: Area Under the Concentration-Time Curve of MK-4700
timeFrame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
measure: Maximum Plasma Concentration (Cmax) of MK-4700
timeFrame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
measure: Minimum Plasma Concentration (Cmin) of MK-4700
timeFrame: Predose and at prespecified time points during Cycles 1, 2, 3, 4, 5, 6, 7, and 10 up to approximately 7 months (Cycle length is 21 days)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center ( Site 0101)
state: Ontario
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0201)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0202)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0200)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: