What side effects are associated with this type of intervention?

Common treatments for metastatic tumors, such as pembrolizumab and other antineoplastic agents, often have side effects including chills, fever, nausea, vomiting, weakness, and headache. Chemotherapy can cause fatigue, hair loss, anemia, and increased risk of infection. Targeted therapies may lead to specific side effects like skin rashes, hypertension, and cardiac dysfunction. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for metastatic tumors, particularly those involving immune checkpoint inhibitors. Pembrolizumab (Keytruda) is a notable example, approved for various metastatic cancers, including melanoma, non-small cell lung cancer, and others. Nivolumab (Opdivo) and ipilimumab (Yervoy) are also approved for metastatic melanoma and other cancers. Additionally, combination therapies such as nivolumab with ipilimumab have shown efficacy in treating metastatic melanoma. These treatments work by enhancing the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to MK-0472 for metastatic tumor patients include amivantamab and mobocertinib for NSCLC with EGFR exon 20 insertion mutations, VS-6766 alone or in combination with defactinib for KRAS-mutant NSCLC, and infigratinib for cholangiocarcinoma with FGFR2 fusions/rearrangements.

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MK-0472 + 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 56 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called MK-0472, alone and with other drugs, in patients with advanced or spreading solid tumors. The goal is to see if it is safe and effective in treating these cancers.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that have alterations in certain genes and who've tried all other treatments. They must not have serious eye conditions, skin disorders, known allergies to the drugs being tested, recent use of certain stomach acid medications, or a history of severe reactions to similar cancer therapies.

What is being tested?

The study tests MK-0472 alone and combined with Pembrolizumab on participants with specific genetic tumor profiles. It aims to evaluate the effectiveness and safety without a primary hypothesis; meaning they're exploring how well these treatments work without trying to prove a specific idea.

What are the potential side effects?

Possible side effects include typical immune therapy-related issues like inflammation in various organs, infusion reactions (problems during drug administration), fatigue, digestive problems, blood disorders, increased risk of infections and potential worsening of autoimmune diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 56 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 56 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 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 Who Discontinue Study Treatment Due to an Adverse Event (AE)

Number of Participants Who Experience One or More Adverse Events (AEs)

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Secondary study objectives

Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of MK-0472

Lowest Plasma Concentration (Ctrough) of MK-0472

Maximum Serum Concentration (Cmax) of MK-0472

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-0472 + PembrolizumabExperimental Treatment2 Interventions

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).

Group II: MK-0472 + MK-1084Experimental Treatment2 Interventions

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule QD until disease progression or withdrawal/discontinuation.

Group III: MK-0472Experimental Treatment1 Intervention

Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-1084

2024

Completed Phase 1

~120

Pembrolizumab

2017

Completed Phase 3

~3130

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

Common treatments for metastatic tumors include targeted therapies and immunotherapies. Targeted therapies inhibit specific molecules like tyrosine kinases that are essential for tumor growth and survival. Immunotherapies boost the immune system's ability to recognize and destroy cancer cells. These approaches are important for metastatic tumor patients as they provide more personalized treatment options, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.

The Mechanism of Action of Regorafenib in Colorectal Cancer: A Guide for the Community Physician.Clinical and histopathological features of carcinosarcoma of the renal pelvis: a systematic review of a rare tumor.[New recommendations in oncocardiology].