NCT06307431Active, not recruitingPhase 2
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).
Merck Sharp & Dohme LLC125 sites in 11 countries272 target enrollmentStarted: April 10, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 272
- Locations
- 125
- Primary Endpoint
- Disease-Free Survival (DFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Intismeran autogene + Pembrolizumab
Experimental
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.
Intervention: Intismeran autogene (Biological)
Intismeran autogene + Pembrolizumab
Experimental
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.
Intervention: Pembrolizumab (Biological)
Placebo + Pembrolizumab
Active Comparator
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.
Intervention: Placebo (Biological)
Placebo + Pembrolizumab
Active Comparator
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.
Intervention: Pembrolizumab (Biological)
Outcomes
Primary Outcomes
Disease-Free Survival (DFS)
Time Frame: 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 Outcomes
- Percentage of Participants Who Experience an Adverse Event (AE)(up to ~15 months)
- Overall Survival (OS)(up to ~96 months)
- Percentage of Participants Who Discontinue Study Treatment Due to an AE(up to ~12 months)
- Distant Metastasis-free survival (DMFS)(up to ~ 43 months)
Investigators
Study Sites (125)
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