a study of adjuvant intismeran autogene (v940) and pembrolizumab in renal cell carcinoma (v940-004).

Conditions: Renal Cell Carcinoma

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.


Eligibility criteria:
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

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1(pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)