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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT06307431
Run by: Merck Sharp & Dohme LLC
People needed: 272
Starts: 2024-04-10
Expected to finish: 2032-06-08
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro — Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 0108) — San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102) — New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109) — Boston, Massachusetts, United States
Dana-Farber Cancer Institute-GU ( Site 0101) — Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center ( Site 0100) — New York, New York, United States
Duke Cancer Institute ( Site 0106) — Durham, North Carolina, United States
Abramson Cancer Center ( Site 0107) — Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0111) — Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center ( Site 0110) — Dallas, Texas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1106) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 1101) — Buenos Aires, Buenos Aires F.D., Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110) — Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Rio Cuarto ( Site 1104) — Río Cuarto, Córdoba Province, Argentina
Fundacion Estudios Clinicos ( Site 1111) — Rosario, Santa Fe Province, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502) — Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 1501) — Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si — Brisbane, Queensland, Australia
Fiona Stanley Hospital-Medical Oncology ( Site 1503) — Murdoch, Western Australia, Australia
BC Cancer Vancouver ( Site 0005) — Vancouver, British Columbia, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008) — Québec, Quebec, Canada
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
Bradfordhill-Clinical Area ( Site 1201) — Santiago, Region M. de Santiago, Chile
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104) — Duarte, California, United States

Full record on ClinicalTrials.gov

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