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

Get Involved

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06894771
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Merck Sharp & Dohme LLC
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Merck Sharp & Dohme LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Israel, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Neoplasm
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Interventions

Biological: - MK-4700

Administered via subcutaneous (SC) injection

Biological: - Pembrolizumab

Administered via intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hackensack 5098706, New Jersey 5101760

Status

Recruiting

Address

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

Hackensack 5098706, New Jersey 5101760, 07601

Site Contact

Study Coordinator

[email protected]

551-996-5863

NEXT Oncology ( Site 0300), San Antonio 4726206, Texas 4736286

Status