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

NCT06894771 | Completed Phase 1 FDA Drug

• 2 other identifiers: 4700-001MK-4700-001
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT)

  The occurrence of any of the following toxicities during Cycle 1 will be considered a DLT, if assessed by the investigator related to study intervention administration: * Grade 4 nonhematologic toxicity * Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia * Any nonhematologic AE ≥Grade 3 in severity, with exceptions * Any Grade 3 or Grade 4 nonhematologic laboratory value, as with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory abnormalities, with the exceptions * Febrile neutropenia Grade 3 or Grade 4 * Prolonged delay (\>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any study drug toxicity that causes the participant to discontinue study drug during Cycle 1 * Missing \>25% of MK-4700 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity

  Cycle 1 (up to 21 days)

• Percentage of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 4.5 years

• Percentage of Participants who Discontinue Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 4.5 years

Secondary Outcomes (3)

• Area Under the Concentration-Time Curve of MK-4700

  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)

• Maximum Plasma Concentration (Cmax) of MK-4700

  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)

• Minimum Plasma Concentration (Cmin) of MK-4700

  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)

Study Arms (2)

Arm 1: MK-4700

EXPERIMENTAL

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.

Biological: MK-4700

Arm 2: MK-4700 + Pembrolizumab

EXPERIMENTAL

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.

Biological: MK-4700; Biological: Pembrolizumab

Interventions

MK-4700 BIOLOGICAL

Administered via subcutaneous (SC) injection

Arm 1: MK-4700; Arm 2: MK-4700 + Pembrolizumab

Pembrolizumab BIOLOGICAL

Administered via intravenous infusion

Also known as: MK-3475, KEYTRUDA®

Arm 2: MK-4700 + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (7)

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0301)

Hackensack, New Jersey, 07601, United States

Location

NEXT Oncology ( Site 0300)

San Antonio, Texas, 78229, United States

Location

Princess Margaret Cancer Center ( Site 0101)

Toronto, Ontario, M5G 2M9, Canada

Location

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0102)

Québec, Quebec, G1J 1Z4, Canada

Location

Rambam Health Care Campus ( Site 0201)

Haifa, 3109601, Israel

Location

Rabin Medical Center ( Site 0202)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 0200)

Ramat Gan, 5265601, Israel

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Neoplasms; Squamous Cell Carcinoma of Head and Neck; Melanoma; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Renal Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Neoplasms; Breast Diseases; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 25, 2025
• Study Start: April 23, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (2); IL (3); US (2)