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

Part of paid clinical trials in Duarte, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06307431
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intismeran autogene — BIOLOGICAL
    IM injection
  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Placebo — BIOLOGICAL
    IM injection

Study Details

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 Dates

Start date
Apr 10, 2024
Status verified
Aug 2025
Primary completion
Jan 8, 2028
Completion
Jun 8, 2032

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intismeran autogene + Pembrolizumab
    Participants will receive intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks (Q3W) for up to 9 doses plus Pembrolizumab 400 mg via an intravenous (IV) infusion every 6 weeks (Q6W) for 9 cycles (up to \~54 weeks). Each cycle is 6 weeks.
  • Active Comparator: Placebo + Pembrolizumab
    Participants will receive placebo as an IM injection Q3W for up to 9 doses plus Pembrolizumab 400 mg via an IV infusion Q6W for 9 cycles (up to \~54 weeks). Each cycle is 6 weeks.

Primary Outcome Measure

Disease-Free Survival (DFS) [ Time Frame: up to ~43 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)DuarteCalifornia91010-
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of UroLos AngelesCalifornia90095-
UCSF Medical Center at Mission Bay ( Site 0108)San FranciscoCalifornia94158-
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)New HavenConnecticut06510-
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)BostonMassachusetts02215-
Dana-Farber Cancer Institute-GU ( Site 0101)BostonMassachusetts02215-
Memorial Sloan Kettering Cancer Center ( Site 0100)New YorkNew York10065-
Duke Cancer Institute ( Site 0106)DurhamNorth Carolina27710-
Abramson Cancer Center ( Site 0107)PhiladelphiaPennsylvania19104-
Fox Chase Cancer Center ( Site 0111)PhiladelphiaPennsylvania19111-
UT Southwestern Medical Center ( Site 0110)DallasTexas75390-

Find similar trials in Duarte, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
City of Hope Comprehensive Cancer Center-Medical Oncology· Duarte, CAUCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro· Los Angeles, CAUCSF Medical Center at Mission Bay· San Francisco, CAYale-New Haven Hospital-Yale Cancer Center· New Haven, CTBeth Israel Deaconess Medical Center-Cancer Clinical Trials Office· Boston, MADana-Farber Cancer Institute-GU· Boston, MA

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