Kidney Cancer Clinical Trial

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

Summary

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab 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.

View Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

272

Study ID:

NCT06307431

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 16 Locations for this study

See Locations Near You

Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
New Haven Connecticut, 06510, United States More Info
Study Coordinator
Contact
203-785-5720
Memorial Sloan Kettering Cancer Center ( Site 0100)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-422-4312
Fox Chase Cancer Center ( Site 0111)
Philadelphia Pennsylvania, 19111, United States More Info
Study Coordinator
Contact
215-728-3889
Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
Ciudad Autónoma de Buenos Aires Caba, 1426, Argentina More Info
Study Coordinator
Contact
5491149455892
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
Macquarie University New South Wales, 2109, Australia More Info
Study Coordinator
Contact
+61 2 9812 3526
Westmead Hospital-Department of Medical Oncology ( Site 1501)
Westmead New South Wales, 2145, Australia More Info
Study Coordinator
Contact
61411462609
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane Queensland, 4029, Australia More Info
Study Coordinator
Contact
61402240196
BC Cancer Vancouver ( Site 0005)
Vancouver British Columbia, V5Z 4, Canada More Info
Study Coordinator
Contact
6048776000
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
Québec Quebec, G1R 2, Canada More Info
Study Coordinator
Contact
4185254444
FALP-UIDO ( Site 1202)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56224457254
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
56223547919
Bradfordhill-Clinical Area ( Site 1201)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56954240753
ONCOCENTRO APYS-ACEREY ( Site 1200)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan More Info
Study Coordinator
Contact
+886773171233267
China Medical University Hospital-Department of Urology ( Site 1702)
Taichung , 40447, Taiwan More Info
Study Coordinator
Contact
886-975-681295
Taipei Veterans General Hospital ( Site 1703)
Taipei , 112, Taiwan More Info
Study Coordinator
Contact
886228757519

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

272

Study ID:

NCT06307431

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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