A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004) (INTerpath-004)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Biological: Pembrolizumab; Biological: V940; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06307431

U1111-1291-1851 (Other Identifier)

V940-004

2023-505177-32 (Other Identifier)

Details and patient eligibility

About

The primary objective of the study is to compare V940 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 V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Enrollment: 272 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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272 participants in 2 patient groups

V940 + Pembrolizumab

Experimental group

Description:

Participants will receive V940 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.

Treatment:

Biological: V940

Biological: Pembrolizumab

Placebo + Pembrolizumab

Active Comparator group

Description:

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.

Treatment:

Biological: Placebo

Biological: Pembrolizumab