A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307431
• Other study ID #: V940-004
• Secondary ID: 2023-505177-32
• Status: Recruiting
• Phase: Phase 2
• Start date: April 10, 2024
• Est. completion date: June 8, 2032

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: June 8, 2032
• Est. primary completion date: January 8, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
• Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as

defined by the following pathological tumor-node metastasis and tumor grading:

• Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
• High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
• M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or =2 years from nephrectomy (metachronous)
• Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
• Must have undergone a nephrectomy and/or metastasectomy =12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

Exclusion Criteria:

• Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
• Has residual thrombus post nephrectomy in the vena renalis or vena cava.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Received prior treatment with a cancer vaccine.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has a history of brain or bone metastatic lesions.
• Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic therapy.
• History of allogeneic tissue/solid organ transplant.
• Has not adequately recovered from major surgery or has ongoing surgical complications.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• V940
IM injection
• Pembrolizumab
IV infusion
• Placebo
IM injection

Locations

Country	Name	City	State
Australia	Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)	Macquarie University	New South Wales
Canada	CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)	Québec	Quebec
Chile	Bradfordhill-Clinical Area ( Site 1201)	Santiago	Region M. De Santiago
Chile	FALP-UIDO ( Site 1202)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)	Santiago	Region M. De Santiago
Chile	ONCOCENTRO APYS-ACEREY ( Site 1200)	Viña del Mar	Valparaiso
Taiwan	Taipei Veterans General Hospital ( Site 1703)	Taipei
United States	Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center ( Site 0100)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival (DFS)	DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.	up to ~43 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	up to ~96 months
Secondary	Distant Metastasis-free survival (DMFS)	DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.	up to ~ 43 months
Secondary	Percentage of Participants Who Experience an Adverse Event (AE)	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants that experience at least one AE will be reported.	up to ~15 months
Secondary	Percentage of Participants Who Discontinue Study Treatment Due to an AE	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.	up to ~12 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary