MK-4716 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called MK-4716 for certain advanced or metastatic cancers. Researchers aim to assess the safety of MK-4716 and its tolerability, both alone and in combination with other treatments like Pembrolizumab and Cetuximab. The trial seeks participants with specific types of solid tumors, such as advanced lung cancer or tumors with a KRAS gene change, who have undergone previous treatments. Participants should have measurable disease and be able to swallow pills. As a Phase 1 trial, this research focuses on understanding how MK-4716 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have received prior immunotherapy, you may not be eligible for certain parts of the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study on MK-4716 focused on its safety when used alone or with other treatments. When combined with pembrolizumab, the drug showed a manageable safety profile. Most side effects were mild or moderate, such as tiredness or nausea. Pembrolizumab, already used for other cancers, typically causes mild side effects, which are well-known and manageable.
For MK-4716 combined with cetuximab, cetuximab is approved for some cancers and usually causes side effects like skin reactions and low magnesium levels. These are common and treatable.
Since MK-4716 is in an early trial phase, the main goal is to test its safety. At this stage, researchers aim to find the right dose and check for any side effects, but clear data on MK-4716 alone remains limited. This trial is crucial to ensure the treatment is safe and tolerable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about MK-4716 for cancer because it offers a unique approach compared to standard treatments like chemotherapy and targeted therapies. Unlike most treatments that attack cancer cells directly, MK-4716 may work by enhancing the body's immune response to target cancer cells more effectively. Additionally, when combined with drugs like Pembrolizumab or Cetuximab, MK-4716 has the potential to improve the effectiveness of these existing immunotherapy and targeted therapy options, potentially leading to better outcomes for patients. This new mechanism and combination strategy represent a promising step forward in cancer treatment.
What evidence suggests that MK-4716 could be an effective treatment for advanced or metastatic solid tumors?
Studies have shown that researchers are investigating MK-4716 for its potential to treat certain advanced cancers. This drug targets specific cancer pathways, which may stop tumors from growing. In this trial, participants will receive MK-4716 in different treatment arms. One arm involves MK-4716 alone at varying dose levels and schedules. Another arm combines MK-4716 with pembrolizumab, a drug that helps the immune system fight cancer and has shown some success in treating lung cancer. Researchers are also exploring a combination of MK-4716 with cetuximab, which has been helpful for some colorectal cancers. Although much remains to be learned, these early results offer promise for people with difficult-to-treat tumors.16789
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for people with certain advanced solid tumors who've had at least one systemic therapy. Specifically, it's for those with a confirmed diagnosis of unresectable or metastatic solid tumors or non-small cell lung cancer that have KRAS alterations. Participants must be able to swallow pills and haven't been treated yet if they have lung cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-4716 as monotherapy or in combination with Pembrolizumab or Cetuximab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Pharmacokinetics Assessment
Blood samples are collected to determine pharmacokinetic parameters such as AUC, Cmax, and Ctrough of MK-4716
What Are the Treatments Tested in This Trial?
Interventions
- MK-4716
Trial Overview
The study is testing the safety and tolerance of MK-4716 alone or combined with Cetuximab or Pembrolizumab in treating advanced cancers. It aims to find out how well these treatments work on specific solid tumors, including those with genetic changes like KRAS mutations.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants receive MK-1084 at varying dose levels and schedules.
Participants will receive MK-4716 + Pembrolizumab
Participants will receive MK-4716 + Cetuximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
A Clinical Study of MK-4716 in People With Certain Solid ...
Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid ...
Chemotherapeutic Effectiveness of Combining Cetuximab for ...
Our results showed that cetuximab could significantly prolong PFS and OS in mCRC patients with wild type KRAS, but did not remarkably improve ...
3.
sigma.larvol.com
sigma.larvol.com/company.php?e1=318830&e2=&sourcepg=TZC&tab=OTTtrac&sr=now&er=1+month&ipwnd=on&rlink=,tab=OTTtrac,sourcepg=TZC,itype=0,1&rflag=1&page=8EMD Serono Trials
MK-4716, Pembrolizumab, Keytruda, Cetuximab. Merck Sharp & Dohme LLC ... COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE ( ...
Long-term Survival and Molecular Biomarker Evaluation of ...
At a median follow-up of 47.4 months, median overall survival (OS) and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n=88) ...
NCT06589804 | Testing the Addition of Anti-Cancer Drug ...
Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone. Detailed ...
A Clinical Study of MK-4716 in People With Certain Solid ...
Blood samples will be collected to estimate Cmax of MK-4716. At designated timepoints (up to approximately 58 days). Trough Plasma Concentration (Ctrough) of MK ...
A Study of MK-4700 Alone or With Pembrolizumab in ...
The goal of this study is to learn about the safety of different doses of MK-4700 and if people tolerate them. The study will also measure what happens in a ...
8.
ctv.veeva.com
ctv.veeva.com/study/construction-and-evaluation-of-tumor-immunotherapy-and-organ-damage-early-warning-system-based-on-muConstruction and Evaluation of Tumor Immunotherapy and ...
By integrating biochemical indicators and related hemodynamic data, it constructs a risk early-warning system for organ damage in patients ...
Everything Comes with a Price: The Toxicity Profile of DNA ...
This review provides a comprehensive overview on the safety profile of DDR-targeting agents, including indications for their management in clinical practice.
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