A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
NCT06307431
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Merck Sharp & Dohme LLC
Start date
2024-04-10
Number of sites
- Summary
- The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
- Acronym
- INTerpath-004
- Short title
- A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
- 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 (INTerpath-004).
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2032-06-08
- First posted
- 2024-03-12
- Registry last updated
- 2026-07-13
- Primary completion date
- 2028-01-08
- Start date
- 2024-04-10
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06307431
- ClinicalTrials.gov ID
- NCT06307431
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Sources for study design
Disease-Free Survival (DFS)
Timeframe: up to ~43 months
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.
Overall Survival (OS)
Timeframe: up to ~96 months
OS is defined as the time from randomization to death due to any cause.
Distant Metastasis-free survival (DMFS)
Timeframe: up to ~ 43 months
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.
Percentage of Participants Who Experience an Adverse Event (AE)
Timeframe: up to ~15 months
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.
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: up to ~12 months
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.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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 has 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
Sources for eligibility
- City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)Duarte, United States
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of UroLos Angeles, United States
- UCSF Medical Center at Mission Bay ( Site 0108)San Francisco, United States
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)New Haven, United States
- Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)Boston, United States
- Dana-Farber Cancer Institute-GU ( Site 0101)Boston, United States
- Memorial Sloan Kettering Cancer Center ( Site 0100)New York, United States
- Duke Cancer Institute ( Site 0106)Durham, United States
- Abramson Cancer Center ( Site 0107)Philadelphia, United States
- Fox Chase Cancer Center ( Site 0111)Philadelphia, United States
- UT Southwestern Medical Center ( Site 0110)Dallas, United States
- Hospital Británico de Buenos Aires-Oncology ( Site 1106)Ciudad Autónoma de Buenos Aires, Argentina
- Instituto Alexander Fleming-Alexander Fleming ( Site 1101)Buenos Aires, Argentina
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)Buenos Aires, Argentina
- Centro Privado de RMI Rio Cuarto ( Site 1104)Río Cuarto, Argentina
- Fundacion Estudios Clinicos ( Site 1111)Rosario, Argentina
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)Macquarie University, Australia
- Westmead Hospital ( Site 1501)Westmead, Australia
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( SiBrisbane, Australia
- Fiona Stanley Hospital-Medical Oncology ( Site 1503)Murdoch, Australia
- BC Cancer Vancouver ( Site 0005)Vancouver, Canada
- CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)Québec, Canada
- FALP-UIDO ( Site 1202)Santiago, Chile
- Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)Santiago, Chile
- Bradfordhill-Clinical Area ( Site 1201)Santiago, Chile
And 38 more, listed on the interactive page.
Sources for sites
- Related resource (www.merckclinicaltrials.com)
- V940-004
- 2023
- U1111-1291-1851
- 2023-505177-32-00
Sources for references
Related records
Drugs (2)
Collaborators (1)
Lead sponsors (1)
Conditions (1)
- Renal cell carcinoma Primary condition