A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)

Neoplasm Metastasis Clinical Trial

Official title:

A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460961
• Other study ID #: 6837-001
• Secondary ID: MK-6837-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 15, 2024
• Est. completion date: July 13, 2029

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 13, 2029
• Est. primary completion date: July 13, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic

• Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)

• Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation

• Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier

• History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years

• Has clinically significant cardiovascular disease

• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

• Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention

• Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis

• Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids

• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed

• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention

• Known additional malignancy that is progressing or has required active treatment within the past 2 years

• Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis

• Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy

• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

• Active infection requiring systemic therapy

• History of allogeneic tissue/solid organ transplant

• Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Biological:
• MK-6837
IV Infusion
• Pembrolizumab
IV Infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experience one or more dose-limiting toxicities (DLTs)	The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting >7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (>2 weeks) in initiating treatment after the first 21 days due to intervention-related toxicity; Any intervention-related toxicity that causes the participant to discontinue intervention during the first 21 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.	Cycle 1 (Up to approximately 21 days); each cycle is 21 days.
Primary	Number of participants who experience one or more adverse events (AEs)	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 59 months
Primary	Number of participants who discontinue study intervention 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 59 months
Secondary	Maximum concentration (Cmax) of MK-6837 in plasma	The Cmax of MK-6837 in plasma will be determined.	Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days
Secondary	Minimum concentration (Ctrough) of MK-6837 in plasma	The Ctrough of MK-6837 in plasma will be determined.	Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days
Secondary	Area Under the Concentration-Time Curve (AUC) of MK-6837 in plasma	The AUC of MK-6837 in plasma will be determined.	Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days

External Links

•   Merck Clinical Trials Information