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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
272
IM injection
IV infusion
IM injection
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.
Time frame: up to ~43 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: up to ~96 months
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.
Time frame: up to ~ 43 months
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.
Time frame: up to ~15 months
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.
Time frame: up to ~12 months
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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
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UCSF Medical Center at Mission Bay ( Site 0108)
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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)
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Dana-Farber Cancer Institute-GU ( Site 0101)
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Memorial Sloan Kettering Cancer Center ( Site 0100)
New York, New York, United States
Duke Cancer Institute ( Site 0106)
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Abramson Cancer Center ( Site 0107)
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Fox Chase Cancer Center ( Site 0111)
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