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New treatment option for Malignant Melanoma
Official title A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
ClinicalTrials.gov ID: NCT06961006
What this study is testing
What is Intismeran autogene?
Intismeran autogene is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for malignant melanoma.
Also referred to as mRNA-4157, V940.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following:
- Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition...
- Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as...
- Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local...
- Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid...
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well...
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has ocular or mucosal melanoma.
- Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including...
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell...
See the full eligibility criteria
- The main include but are not limited to the following:
- Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein [CTLA-4]...
- Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF...
- Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site...
- Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study.
- Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- The main exclusion criteria include but are not limited to the following:
- Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has ocular or mucosal melanoma.
- Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating...
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 [LAG-3], tumor...
- Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.
- Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Received prior treatment with another universal or personalized cancer vaccine.
The study team makes the final eligibility decision.
Where it's taking place
- Springdale, Arkansas, United States
- San Francisco, California, United States
- Hackensack, New Jersey, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Blacktown, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
- Nedlands, Western Australia, Australia
- Brampton, Ontario, Canada
- Toronto, Ontario, Canada
- Nice, Alpes-Maritimes, France
- Paris, Île-de-France Region, France
- Villejuif, Île-de-France Region, France
- Heidelberg, Baden-Wurttemberg, Germany
- Frankfurt am Main, Hesse, Germany
- Cologne, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Hamburg, Germany
- Athens, Attica, Greece
- Thessaloniki, Greece
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springdale, Arkansas, United States; San Francisco, California, United States; Hackensack, New Jersey, United States; Fairfax, Virginia, United States; Seattle, Washington, United States; Blacktown, New South Wales, Australia and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.