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MK-4464 + Pembrolizumab for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 27 months

Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective for treating advanced cancer.

Who is the study for?

This trial is for adults with advanced solid tumors who've tried, can't tolerate, or refused all other treatments. They must have a good performance status (0-1 on the ECOG scale), controlled HIV or hepatitis B if present, and provide a tumor sample. Excluded are those with recent cancer therapies, active CNS metastases, infections needing treatment, lung disease requiring steroids, autoimmune diseases treated in the last 2 years, major surgery effects not recovered from, live vaccines taken within 30 days before starting the study intervention.Check my eligibility

What is being tested?

The study tests MK-4464 alone and combined with Pembrolizumab to evaluate safety and early effectiveness in treating advanced solid tumors. It also looks at how the body processes these drugs (pharmacokinetics). Participants will be randomly assigned to receive either MK-4464 by itself or alongside Pembrolizumab.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to pembrolizumab such as inflammation of organs; infusion reactions; fatigue; skin issues; hormonal gland problems like thyroid disorders; liver function changes. Side effects specific to MK-4464 aren't detailed but could overlap or differ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience At Least One adverse event (AE)

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve (AUC) of MK-4464

Maximum Plasma Concentration (Cmax) of MK-4464

Minimum Plasma Concentration (Cmin) of MK-4464

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464Experimental Treatment3 Interventions

Participants will receive an IV infusion of 89Zr-MK-4464 + IV infusion of MK-4464 on Cycle 1 Day 1, followed by an IV infusion of MK-4464 + a 200 mg IV infusion of pembrolizumab starting on Cycle 2 Day 1 and every 3 weeks for up to 35 cycles. Each cycle=3 weeks. MK-4464 doses will be based on safety of MK-4464 monotherapy arm. Participants may receive a 200 mg IV infusion of pembrolizumab on cycle 36.

Group II: MK-4464 + PembrolizumabExperimental Treatment2 Interventions

Participants will receive an IV infusion of MK-4464 administered in escalating doses and a 200 mg IV infusion of Pembrolizumab every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of MK-4464 monotherapy arm.

Group III: MK-4464Experimental Treatment1 Intervention

Participants will receive an intravenous (IV) infusion of MK-4464 administered in escalating doses every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of previous dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,411 Total Patients Enrolled

11 Trials studying Tumors

2,324 Patients Enrolled for Tumors

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,480 Total Patients Enrolled

2 Trials studying Tumors

34 Patients Enrolled for Tumors

Media Library

MK-4464 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05514444 — Phase 1

Tumors Research Study Groups: MK-4464, MK-4464 + Pembrolizumab, MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464

Tumors Clinical Trial 2023: MK-4464 Highlights & Side Effects. Trial Name: NCT05514444 — Phase 1

MK-4464 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514444 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could taking MK-4464 + 89Zr-MK-4464 be detrimental to a person's health?

"Due to the limited data surrounding MK-4464 + 89Zr-MK-4464, our team at Power has assigned it a score of 1 on a scale from 1 to 3. This is reflective of its Phase I status, which suggests there are not enough clinical findings yet for full safety and efficacy assessments."

Answered by AI

To what extent has enrollment been achieved for this trial?

"This trial requires 248 qualified participants, who can sign up from multiple locations such as the Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology in Toronto or Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) located in Amsterdam."

Answered by AI

How widely accessible is this medical research?

"This study is recruiting patients from Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology (Site 0201) in Toronto, Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 0401 ) in Amsterdam, Hadassah Medical Center-Oncology( Site 0302 )in Jerusalem, as well as 5 other locations."

Answered by AI

Are new participants being sought for this research endeavor?

"That is correct. As outlined on clinicaltrials.gov, this research programme was initially posted in September of 2022 and the most recent update took place in April of 2023. A total of 248 volunteers need to be sourced from 5 distinct locations for this study to proceed as planned."

Answered by AI

What aims is this research endeavor trying to accomplish?

"This clinical trial has a primary outcome of measuring the number of participants who discontinue their treatment due to an Adverse Event (AE) over up to 27 months. Secondary objectives include determining the Minimum and Maximum Plasma Concentrations (Cmin/Cmax) of MK-4464, as well as the Objective Response Rate (ORR), which is defined by RECIST 1.1 criteria for CR or PR observed in target lesions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

2022. "Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05514444.

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