V940 + Pembrolizumab + Chemotherapy for Lung Cancer
(INTerpath-13 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called V940, which aims to help the immune system combat squamous non-small cell lung cancer that has spread. Researchers seek to determine if V940, combined with pembrolizumab (an immunotherapy drug) and chemotherapy, can extend patients' lives and prevent cancer growth compared to a placebo. Individuals who have not received treatment for their metastatic lung cancer may be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in cancer care.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic steroid therapy or immunosuppressive therapy, you may need to stop or adjust it before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that V940, when combined with pembrolizumab, appears safe based on previous studies. This combination has been tested in patients with various cancer types and has been well-tolerated in past research. Some patients experienced side effects, mostly mild, such as tiredness and flu-like symptoms.
Pembrolizumab is already approved for treating various cancers and is generally considered safe. Most people tolerate it well, though some might experience side effects like fatigue or skin reactions.
Overall, both V940 and pembrolizumab have demonstrated safety in other settings. However, each person's experience can differ. Patients should discuss any treatment safety concerns with their doctor.12345Why do researchers think this study treatment might be promising for lung cancer?
Researchers are excited about V940 in combination with pembrolizumab and chemotherapy for lung cancer because it introduces a novel element to treatment. V940 is a personalized cancer vaccine that aims to boost the immune system's ability to recognize and attack cancer cells more effectively. This is different from traditional treatments like chemotherapy and immune checkpoint inhibitors, which can sometimes struggle to specifically target cancer cells. The combination of V940 with pembrolizumab, an immune checkpoint inhibitor, could enhance the overall immune response, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for lung cancer?
In this trial, participants will receive either V940 with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. Research has shown that V940, when combined with pembrolizumab, may help treat certain cancers. In an earlier study, 74.8% of patients who received both V940 and pembrolizumab remained cancer-free after 2.5 years, compared to 55.6% of those who only received pembrolizumab. This indicates that more patients stayed cancer-free longer with the combination. V940 enhances the immune system's ability to target cancer cells, potentially leading to better treatment results. Evidence suggests this combination might improve outcomes for people with lung cancer, but further research is needed to confirm its effectiveness.12678
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 a specific type of advanced lung cancer called squamous NSCLC who haven't had treatment before. They must have well-controlled HIV or hepatitis if present, provide a recent tissue sample, and have good organ function. People with small cell lung cancer elements or unmanaged health issues from past cancer treatments can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive pembrolizumab and chemotherapy, with V940 or placebo administered during Cycle 2
Maintenance
Participants continue receiving pembrolizumab and V940 or placebo for up to 15 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- V940
Trial Overview
The study tests whether V940 combined with pembrolizumab (an immunotherapy drug) and chemotherapy improves survival in metastatic squamous NSCLC patients compared to placebo plus the same immunotherapy and chemo. Participants are randomly assigned to receive either V940 or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). V940 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. V940 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.
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
ModernaTX, Inc.
Industry Sponsor
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
Merck and Moderna Initiate Phase 3 Trial Evaluating ...
Merck and Moderna have initiated Phase 3 randomized clinical trials evaluating mRNA-4157 (V940) in combination with KEYTRUDA as an adjuvant ...
3-year update from the mRNA-4157-P201 (KEYNOTE-942) ...
The 2.5-yr RFS rate of combo treatment (tx) vs pembro alone was 74.8% vs 55.6%. Combo tx also produced clinically meaningful, sustained ...
NCT06623422 | A Study of Pembrolizumab (MK-3475) ...
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive ...
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.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_2/CT251/761839/Abstract-CT251-Phase-3-INTerpath-009-studyAbstract CT251: Phase 3 INTerpath-009 study: Individualized ...
The INTerpath-009 study (NCT06623422) evaluates adjuvant pembro with and without V940 in pts with resected stage II-IIIB (N2) NSCLC that did not achieve pCR ...
The phase 3 INTerpath-002 study design
Here we present the design of the phase 3, randomized, double-blind INTerpath-002 study (NCT06077760) of adjuvant V940 plus pembro vs placebo plus pembro.
Individualised neoantigen therapy mRNA-4157 (V940) ...
Adjuvant mRNA-4157 plus pembrolizumab prolonged recurrence-free survival versus pembrolizumab monotherapy in patients with resected high-risk ...
T-cell Responses to Individualized Neoantigen Therapy ...
mRNA-4157 (V940) is an individualized neoantigen therapy targeting up to 34 patient-specific tumor neoantigens to induce T-cell responses and potentiate ...
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