What side effects are associated with this type of intervention?

Common side effects of novel anti-cancer agents like MK-4464 can include fatigue, nausea, and potential organ-specific toxicities, though specific side effects depend on the agent's mechanism of action. Pembrolizumab, a PD-1 inhibitor, is associated with immune-related adverse effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe treatment-related adverse effects are less frequent but can include severe pneumonitis and other organ-specific inflammations.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for various cancers, including advanced melanoma, non-small cell lung cancer (NSCLC), and gastric cancer. Other similar PD-1 inhibitors include Nivolumab, which is also approved for melanoma, NSCLC, and esophageal cancer. Additionally, Atezolizumab, a PD-L1 inhibitor, has been approved for use in NSCLC and urothelial carcinoma. These immunotherapies work by blocking the PD-1/PD-L1 pathway, enhancing the immune system's ability to fight cancer. The trial MK-4464 is investigating a potential anti-cancer agent, and while its exact mechanism is under investigation, it may offer a novel approach to cancer treatment.

What other types of research exist?

Promising novel alternatives to MK-4464 and Pembrolizumab for tumor patients include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown efficacy in renal cell carcinoma and other cancers. 2) Atezolizumab (PD-L1 inhibitor) combined with Bevacizumab (VEGF inhibitor), particularly for renal cell carcinoma. 3) AKT inhibitors, although recent phase 3 trials in TNBC have been challenging, they remain a potential target. 4) Novel immunomodulators and checkpoint inhibitor combinations for anal cancer, which are expected to shift the treatment paradigm. These alternatives offer different mechanisms of action and are under active investigation or have shown promising results in clinical trials.

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MK-4464 + Pembrolizumab for Advanced Cancer

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial is testing a new drug called MK-4464 alone and with an existing cancer drug, pembrolizumab, in patients with advanced or spreading solid tumors. The goal is to see if these treatments are safe and effective.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2810

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab, a PD-1 inhibitor, works by blocking the PD-1 pathway, which tumors use to evade the immune system, thereby reactivating T-cells to attack cancer cells. The investigational agent MK-4464 is being studied for its potential to disrupt cancer cell growth or enhance immune response. Understanding these mechanisms helps patients grasp the rationale behind their treatment options and potential outcomes.