RECRUITING

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Conditions

Metastatic Solid Tumors Advanced Solid Tumors Programmed Cell Death-1 (PD1, PD-1)Programmed Death-Ligand 1 (PDL1, PD-L1)Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Official Title

A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.

Quick Facts

Study Start:2023-07-06

Study Completion:2028-02-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05853367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report with oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing and have received, or been intolerant to, all available treatment known to confer clinical benefit * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\>4 weeks) antiretroviral therapy (ART) * For Arm 3 Only: Has histologically OR blood-based confirmation of KRAS G12C mutation	* Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study * Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * History of hyperparathyroidism or hypercalcemia * Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease * Has clinically significant cardiovascular disease * Bullous exfoliative skin disorders of any grade * Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients * Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing * Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event * Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * 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. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has history of allogeneic tissue/solid organ transplant * Have not adequately recovered from major surgery or have ongoing surgical complications

Inclusion Criteria

Exclusion Criteria

* Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report with oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing and have received, or been intolerant to, all available treatment known to confer clinical benefit
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\>4 weeks) antiretroviral therapy (ART)
* For Arm 3 Only: Has histologically OR blood-based confirmation of KRAS G12C mutation

* Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study
* Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
* History of hyperparathyroidism or hypercalcemia
* Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease
* Has clinically significant cardiovascular disease
* Bullous exfoliative skin disorders of any grade
* Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients
* Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing
* Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
* 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. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
* Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has history of allogeneic tissue/solid organ transplant
* Have not adequately recovered from major surgery or have ongoing surgical complications

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Northwestern Memorial Hospital ( Site 0002)

Chicago, Illinois, 60611

United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-06

Study Completion Date2028-02-12

Study Record Updates

Study Start Date2023-07-06

Study Completion Date2028-02-12

Terms related to this study

Keywords Provided by Researchers

Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)

Additional Relevant MeSH Terms

Metastatic Solid Tumors
Advanced Solid Tumors