MK-1084 + Pembrolizumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment called MK-1084 to determine its effectiveness in shrinking or eliminating non-small cell lung cancer (NSCLC) with a specific gene change known as KRAS G12C. The trial aims to assess the safety of this treatment and its effectiveness when combined with Pembrolizumab, a medication already used for some cancers. Participants will receive different combinations of treatments, including Pembrolizumab with MK-1084 and other cancer-fighting drugs. Individuals with advanced or metastatic NSCLC, who have a confirmed KRAS G12C mutation and have not received previous treatment targeting KRAS, might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MK-1084 is generally safe. Studies have found that people tolerate it well, both when taken alone and with pembrolizumab. Patients with certain lung cancer mutations have used MK-1084 and experienced manageable side effects.
The drug has been tested on individuals who have already tried other lung cancer treatments. These studies suggest that MK-1084 might be a safe option for treating specific types of lung cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about MK-1084 in combination with Pembrolizumab for lung cancer because it represents a potential breakthrough in targeting tumors more effectively. Unlike standard treatments that mainly focus on traditional chemotherapy, MK-1084 is designed to work alongside Pembrolizumab, an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. This combination aims to enhance the body's natural defenses against cancer, potentially leading to better outcomes for patients. Additionally, MK-1084's unique action could offer a new option for patients who have limited responses to existing therapies.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that MK-1084 holds promise for treating non-small cell lung cancer (NSCLC) with a specific gene change known as KRAS G12C. In this trial, some participants will receive MK-1084 combined with pembrolizumab. Studies have found that this combination can help shrink tumors. Specifically, a previous study showed that about 38% of patients with NSCLC experienced a reduction in tumor size, meaning over a third of patients saw their tumors get smaller. Additionally, the combination of these drugs generally has manageable side effects, making them tolerable. These findings support the potential effectiveness of MK-1084 in treating NSCLC.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 adults with advanced non-squamous NSCLC who have a specific KRAS G12C gene mutation. Participants must provide tumor samples and should not have severe side effects from past cancer treatments. Those with well-controlled HIV or hepatitis B/C (with undetectable viral load) can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pembrolizumab, Carbo platin, Pemetrexed, Cetuximab, and/or MK-1084 based on assigned arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-1084
Trial Overview
The study tests MK-1084, a targeted therapy for NSCLC with the KRAS G12C mutation, in combination with Pembrolizumab, Cetuximab, Pemetrexed, and Carboplatin. The aim is to evaluate the safety of MK-1084 and its effectiveness in reducing or eliminating cancer.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants receive 400 mg of Pembrolizumab every 6 weeks, 500 mg/m\^2 Cetuximab every 2 weeks, and MK-1084 dose regimen
Participants receive 400 mg of Pembrolizumab every 6 weeks, and MK-1084 dose regimen
Participants receive 400 mg of Pembrolizumab every 6 weeks, Carbo platin every 3 weeks and 500 mg/m\^2 of Pemetrexed every 3 weeks.
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
MK-1084 for KRAS G12C-mutated (mut) metastatic non– ...
MK-1084 shows manageable safety and antitumor activity as monotherapy for previously treated disease and in combination with pembro ± chemo as first-line (1L) ...
NCT06345729 | A Study of MK-1084 Plus Pembrolizumab ...
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with locally advanced or metastatic ...
1392TiP Phase III study of pembrolizumab plus MK-1084 ...
Among patients who received first-line treatment for stage IV disease, median PFS was 5.15 mo with ICI alone or in combination with chemotherapy and 2.82 mo for ...
A Study of MK-1084 Plus Pembrolizumab in Participants With ...
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung ...
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cancernetwork.com
cancernetwork.com/view/investigators-launch-phase-3-trial-of-calderasib-combo-in-advanced-nsclcInvestigators Launch Phase 3 Trial of Calderasib Combo in ...
Data from KANDLELIT-001 revealed an ORR of 38% among patients with colorectal cancer, 38% among those with NSCLC, and 34% among those with other ...
NCT07190248 | A Clinical Study of MK-1084 and Other ...
The goal of this study is to learn if people who receive MK-1084 with SC pembrolizumab live longer without the cancer growing or spreading than in people who ...
44O Updated results from a phase I study evaluating the ...
Conclusions. MK-1084 as monotherapy and in combination with pembro showed manageable safety and preliminary antitumor activity in pts with previously treated ...
Merck Announces MK-1084, an Investigational KRAS ...
In patients with advanced KRAS G12C-mutated CRC and NSCLC, a manageable safety profile and antitumor activity were observed with MK-1084 either ...
663P Safety and preliminary efficacy of the KRAS G12C ...
Conclusions. MK-1084 as monotherapy and in combination with pembro showed manageable safety and preliminary antitumor activity in pts with previously treated ...
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