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A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

Active Not RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Renal Cell Carcinoma

Interventions: Intismeran autogene, Pembrolizumab, Placebo

Countries: United States, Argentina, Australia, Canada, Chile, France, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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

Locations (63)

Duarte, California, United States
Los Angeles, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Río Cuarto, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Macquarie University, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
Murdoch, Western Australia, Australia
Vancouver, British Columbia, Canada
Québec, Quebec, Canada
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Viña del Mar, Valparaiso, Chile
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Besançon, Doubs, France
Toulouse, Haute-Garonne, France
Paris, France
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