Intismeran + Pembrolizumab for Lung Cancer

(INTerpath-014 Trial)

Recruiting at 4 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Small cell lung cancer, Cardiovascular disease, Active autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

Duration: Up to approximately 36 months

876 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments to prevent non-small cell lung cancer (NSCLC) from returning after surgery. Participants will receive either a combination of intismeran (an immune-boosting treatment) and pembrolizumab coformulated with berahyaluronidase alfa (an immunotherapy) or intismeran alone. Researchers aim to determine if these treatments can keep patients cancer-free longer compared to a placebo. Individuals who have undergone surgery for Stage I NSCLC with certain high-risk features, such as larger tumors or specific cell changes, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants with HIV or hepatitis B must have controlled conditions with their current treatments, suggesting some medications may be continued. It's best to discuss your specific medications with the trial team.

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

Research shows that the treatments under study are generally safe. Studies have found intismeran to be well-tolerated over several years, with ongoing trials suggesting potential long-term benefits. The combination with pembrolizumab, another treatment in this trial, has also undergone thorough research. Evidence indicates that pembrolizumab, when used with berahyaluronidase alfa, maintains a safety profile consistent with previous studies, indicating it is generally well-tolerated.

Both treatments have been tested in various situations regarding side effects. For pembrolizumab, research confirms its safety in treating non-small cell lung cancer (NSCLC), with consistent results across different administration methods. Intismeran has been studied alongside pembrolizumab in other cancers, showing manageable side effects and good tolerability.

These findings suggest that the trial treatments are generally safe for participants, with known and manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Intismeran and its combination with Pembrolizumab for lung cancer because they offer fresh approaches compared to standard treatments like chemotherapy and traditional immunotherapies. Intismeran works as a novel agent delivered via intramuscular injection, promising a different mechanism that may enhance immune response against cancer cells. The combination with Pembrolizumab, coformulated with berahyaluronidase alfa, allows for subcutaneous administration, potentially improving patient convenience and absorption efficiency. This innovative approach could lead to more effective and user-friendly treatment options for patients battling lung cancer.

What evidence suggests that this trial's treatments could be effective for high-risk, localized NSCLC?

Research has shown that pembrolizumab, when combined with other treatments, has benefited patients with advanced non-small-cell lung cancer (NSCLC). Studies found that pembrolizumab increased survival rates, with 50% of patients still alive after three years when combined with chemotherapy. In this trial, participants in Arm A will receive Intismeran combined with pembrolizumab coformulated with berahyaluronidase alfa. Previous studies indicate that Intismeran, when used with pembrolizumab, significantly lowered the risk of cancer recurrence or death in patients with high-risk conditions after surgery. Five-year data showed a 49% reduction in the risk of cancer returning or causing death for similar conditions. These findings suggest that using Intismeran and pembrolizumab together could help prevent cancer from returning after surgery. Participants in Arm B will receive Intismeran alone, while Arm C will receive a placebo. ^{1 2 3 6 7}

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 high-risk Stage I non-small cell lung cancer (NSCLC) that has been completely removed by surgery. Participants must not have had other treatments for this cancer, and need to provide tissue and blood samples. Certain viral infections are allowed if well-controlled.

Inclusion Criteria

I have hepatitis B but my viral load is undetectable after at least 4 weeks of treatment.

* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

I have Stage I NSCLC (tumor ≤4 cm) with at least one high-risk feature.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intismeran with or without pembrolizumab and berahyaluronidase alfa to prevent NSCLC recurrence

Up to approximately 36 months

Follow-up

Participants are monitored for disease-free survival and adverse events

Up to approximately 144 months

What Are the Treatments Tested in This Trial?

Interventions

• Intismeran
• Pembrolizumab coformulated with berahyaluronidase alfa

Trial Overview

The study tests whether intismeran alone or combined with pembrolizumab plus berahyaluronidase alfa can better prevent lung cancer from returning after surgery compared to a placebo. Treatments are given after surgery in patients at higher risk of recurrence.

How Is the Trial Designed?

Group I: Arm B: Intismeran Experimental Treatment 1 Intervention

Participants will receive intismeran 1 mg via IM injection.

Group II: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa Experimental Treatment 2 Interventions

Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.

Group III: Arm C: Placebo Placebo Group 1 Intervention

Participants will receive dose-matched placebo via IM injection.

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

ModernaTX, Inc.

Industry Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

1.

merck.com

merck.com/news/moderna-merck-announce-5-year-data-for-intismeran-autogene-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-the-primary-endpoint-of-recurrence-free-survival-i/

Moderna & Merck Announce 5-Year Data for Intismeran ...

“Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in ...

2.

finance.yahoo.com

finance.yahoo.com/news/moderna-merck-announce-5-data-110000479.html

Moderna & Merck Announce 5-Year Data for Intismeran ...

"Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/OA-25-00008

Three-Year Update of a Randomized Phase IIb Study ...

Intismeran plus pembrolizumab significantly prolongs RFS and DMFS compared with pembrolizumab alone for the adjuvant treatment of resected high- ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12467296/

mRNA Vaccines in Modern Immunotherapy for Non-Small Cell ...

Two- and three-year survival rates were 26.7% and 20.7%, respectively [22]. A study by Papachristofilou et al. evaluated the safety and efficacy ...

5.

targetedonc.com

targetedonc.com/view/rfs-benefit-sustained-at-5-years-for-intismeran-autogene-in-melanoma

RFS Benefit Sustained at 5 Years for Intismeran Autogene ...

Intismeran autogene with pembrolizumab shows a 49% reduction in recurrence or death risk in patients with high-risk resected melanoma over 5 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39952082/

Five-year efficacy and safety of pembrolizumab as first-line ...

The median overall survival (OS) was 19.1 months (95 %CI; 13.3-24.9 months). The 2-, 3-, and 5-year OS rates were 42.7 %, 33.9 % ...

7.

patsnap.com

patsnap.com/resources/blog/ls-blog/intismeran-autogene-mrna-vaccine-phase-iii-patsnap-eureka/

Intismeran Autogene mRNA Vaccine Phase III

The 3-year recurrence-free survival rate was 74.8% in the combination arm versus 55.6% in the comparator arm. A distant metastasis-free survival ...