A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT06307431
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 272
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intismeran autogene + Pembrolizumab Intismeran autogene 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. Intismeran autogene + Pembrolizumab 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. Placebo + Pembrolizumab 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. Placebo + Pembrolizumab Placebo 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 Measures
Name Time Method Disease-Free Survival (DFS) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experience an Adverse Event (AE) 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.
Overall Survival (OS) up to ~96 months OS is defined as the time from randomization to death due to any cause.
Percentage of Participants Who Discontinue Study Treatment Due to an AE 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.
Distant Metastasis-free survival (DMFS) 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.
Trial Locations
- Locations (63)
Westmead Hospital ( Site 1501)
🇦🇺Westmead, New South Wales, Australia
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
🇺🇸Duarte, California, United States
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
Scroll for more (53 remaining)Westmead Hospital ( Site 1501)🇦🇺Westmead, New South Wales, Australia