A clinical study of V940 and pembrolizumab in people with melanoma (V940-012)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Aug 2025 → ongoing

Decision date (initial)

2025-07-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Moderna Inc · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-519605-36-00

WHO UTN

U1111-1315-5796

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Pharmacogenomic, Therapy, Pharmacokinetic, Pharmacogenetic

To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to PFS per RECIST 1.1 as assessed by the investigator.

Secondary objectives 4

1. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to ORR per RECIST 1.1 as assessed by the investigator.
2. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DOR per RECIST 1.1 as assessed by the investigator.
3. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS.
4. To evaluate the safety and tolerability of V940 plus pembrolizumab.

Conditions and MedDRA coding

Melanoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
2. 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], anti-programmed cell death 1 protein [PD-1] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation.
3. 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 mutation positive melanoma as well as BRAF wild-type or unknown are eligible).
4. Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 as determined by the local site investigator/radiology assessment.
5. 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.
6. Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART).
7. 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 randomization.
8. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclusion criteria 9

1. 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.
2. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
3. Has ocular or mucosal melanoma.
4. 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 factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation).
5. 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, LAG-3, OX-40, CD137), with some exceptions.
6. Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions.
7. Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities.
8. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
9. Received prior treatment with another universal or personalized cancer vaccine.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS)

Secondary endpoints 5

1. Objective Response (OR)
2. Duration of Response (DOR)
3. Overall Survival (OS)
4. Number of participants with ≥1 adverse event (AE)
5. Number of participants discontinuing from study therapy due to AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Toshifumi Hoki

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Toshifumi Hoki

Third parties 13

Locations

7 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications