MK-1084 + Pembrolizumab for Lung Cancer

Recruiting at 8 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Small cell lung cancer, Cardiovascular disease, Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 years

675 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining MK-1084 (an experimental treatment) with subcutaneous pembrolizumab treats non-small cell lung cancer (NSCLC) more effectively than pembrolizumab with chemotherapy. MK-1084 specifically targets a common mutation in this type of lung cancer. The researchers seek to discover if this combination can halt cancer growth or spread for a longer duration. Individuals with NSCLC that cannot be surgically removed or treated with standard therapies might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking 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 have certain conditions like active infections or autoimmune diseases that require treatment, you might not be eligible to participate.

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

Research shows that MK-1084, whether used alone or with pembrolizumab, is generally safe for patients with KRAS G12C-mutated cancers. Most people can handle the treatment without serious side effects. In previous studies, patients did not experience unexpected or dangerous reactions when taking MK-1084 with pembrolizumab.

Pembrolizumab, the other treatment in the trial, has already received FDA approval for treating other cancers, indicating its general safety for patients. People have used pembrolizumab for several years, and its side effects are well-known.

Overall, these two treatments together have been tolerable for many patients. However, everyone can react differently, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lung cancer focus on directly targeting and killing cancer cells through chemotherapy or harnessing the body's immune system with drugs like pembrolizumab. However, the combination of MK-1084 with pembrolizumab is particularly exciting because MK-1084 introduces a novel mechanism that may enhance the immune system's ability to fight cancer. MK-1084, combined with pembrolizumab, potentially boosts immune response more effectively than standard treatments alone. This combination could lead to improved outcomes for patients, offering hope for more effective and long-lasting responses against lung cancer.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research shows that using MK-1084 with pembrolizumab may help treat non-small cell lung cancer (NSCLC) with a specific genetic change known as the KRAS G12C mutation. In this trial, one group of participants will receive MK-1084 and pembrolizumab, along with berahyaluronidase alfa. Studies have found that MK-1084, whether used alone or with pembrolizumab, is generally safe and can shrink tumors in patients who have already undergone other treatments. Early results suggest this combination might help patients live longer without their cancer growing or spreading. These findings offer hope, especially for those with the KRAS G12C mutation. Researchers are actively studying the combination of MK-1084 and pembrolizumab because of its potential benefits. ^{1 2 3 5 6}

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 a type of lung cancer called non-squamous NSCLC, stages IIIB to IV. They must not be candidates for surgery or chemoradiation aimed at curing the disease. If they have HIV, it needs to be well-controlled with medication.

Inclusion Criteria

My lung cancer is advanced and cannot be treated with surgery or chemoradiation.

I have HIV and it is well controlled with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab (+) berahyaluronidase alfa and chemotherapy or MK-1084 with pembrolizumab (+) berahyaluronidase alfa

Up to 2 years

Day 1 of each 6-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 81 months

What Are the Treatments Tested in This Trial?

Interventions

• MK-1084
• Pembrolizumab

Trial Overview The study is testing MK-1084 combined with an under-the-skin version of pembrolizumab against pembrolizumab with chemotherapy (Pemetrexed and either Cisplatin or Carboplatin). The goal is to see if MK-1084 can help patients live longer without their cancer growing.

How Is the Trial Designed?

Group I: MK-1084 + Pembrolizumab (+) Berahyaluronidase alfa Experimental Treatment 2 Interventions

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus MK-1084 until discontinuation criterion is met.

Group II: Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy Active Control 4 Interventions

Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks).

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8605

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) ...

2. merck.com merck.com/news/merck-initiates-phase-3-clinical-trial-of-mk-1084-an-investigational-oral-kras-g12c-inhibitor-in-combination-with-keytruda-pembrolizumab-for-first-line-treatment-of-certain-patients-with-met/

Merck Initiates Phase 3 Clinical Trial of MK-1084, an ... Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial (NCT06345729) evaluating once daily MK-1084 in combination with KEYTRUDA.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02966-1/pdf

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 ...

4. msdclinicaltrials.com msdclinicaltrials.com/trial/nct06345729/

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 locally advanced or metastatic ...

5. esmoopen.com esmoopen.com/article/S2059-7029(24)00041-3/pdf

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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05067283

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 ...