150 Participants Needed

MK-1084 + Cetuximab for Cancer

(KANDLELIT-014 Trial)

Recruiting at 7 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MK-1084, an experimental treatment, alone or with cetuximab, can shrink or eliminate certain advanced cancers in individuals with a specific gene change called the KRAS G12C mutation. Researchers aim to assess the effectiveness and safety of these treatments. The trial seeks participants with advanced solid tumors (excluding colorectal cancer) that have not responded to standard treatments and possess the KRAS G12C mutation. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK-1084, whether used alone or with cetuximab, generally has a manageable safety profile for patients with certain advanced cancers. Most patients tolerate MK-1084 on its own, though some experience usually manageable side effects. In studies, about 58% of patients taking only MK-1084 reported treatment-related side effects.

When combined with cetuximab, early data suggest that this combination remains manageable in terms of safety. However, more patients tend to experience side effects with both drugs, with 94% reporting some side effects. Despite this, the combination is still considered tolerable.

In summary, both MK-1084 alone and with cetuximab are generally safe, though side effects can occur, especially when the drugs are used together.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-1084 and its combination with Cetuximab because they offer new approaches for treating cancer. Unlike standard treatments, which often target cancer cells broadly, MK-1084 works by targeting specific molecular pathways that are less likely to affect healthy cells. This precision could lead to fewer side effects and improve patient outcomes. Furthermore, when combined with Cetuximab, an established cancer therapy, MK-1084 may enhance the overall effectiveness by attacking cancer through multiple mechanisms. This combination approach provides a promising new avenue for tackling difficult-to-treat cancers.

What evidence suggests that MK-1084 alone or with cetuximab could be effective for advanced solid tumors with the KRAS G12C mutation?

Research shows that MK-1084 may help treat certain advanced solid tumors with the KRAS G12C mutation. In this trial, participants will receive either MK-1084 alone or in combination with cetuximab. Studies found that MK-1084 alone caused tumors to shrink in 38% of patients. When combined with cetuximab, this increased to 46%. Additionally, the combination stopped cancer growth in 92% of cases. These findings suggest that MK-1084, both alone and with cetuximab, can be effective against tumors with the KRAS G12C mutation.26789

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors, excluding colorectal cancer, that have worsened despite standard treatments. Participants must have a specific genetic change called the KRAS G12C mutation in their tumor.

Inclusion Criteria

My cancer, not colorectal, is advanced and didn't respond to standard treatments.
My tumor has the KRAS G12C mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-1084 alone or in combination with Cetuximab until criteria for discontinuation are met

Up to 76 months
Bi-weekly visits for Cetuximab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cetuximab
  • MK-1084
Trial Overview The study is testing MK-1084 alone or combined with cetuximab to see if they can shrink or eliminate tumors in people with the KRAS G12C mutation. It aims to compare how well each treatment works and assess their safety and tolerability.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: MK-1084 + CetuximabExperimental Treatment2 Interventions
Group II: MK-1084Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

The KRAS G12C inhibitor MK-1084 for ...Treatment-related AEs occurred in 62% of pts in arms 1+3, 97% of pts in arm 5, and 90% of pts in arm 6, were grade ≥3 in 9%, 18%, and 25%, ...
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 ...
NCT05067283 | A Study of MK-1084 in KRAS Mutant ...This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with ...
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.
An updated overview of K-RAS G12C inhibitors in advanced ...These findings suggest that MK-1084, both as a monotherapy and in combination with pembrolizumab, holds promise in treating patients with advanced solid tumors ...
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) ...
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 ...
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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