A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
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.
Conditions:
๐Ÿฆ  Renal Cell Carcinoma
๐Ÿ—“๏ธ Study Start (Actual) 10 April 2024
๐Ÿ—“๏ธ Primary Completion (Estimated) 8 January 2028
โœ… Study Completion (Estimated) 8 June 2032
๐Ÿ‘ฅ Enrollment (Estimated) 272
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase PHASE2
Locations:
๐Ÿ“ Duarte, California, United States
๐Ÿ“ New Haven, Connecticut, United States
๐Ÿ“ Boston, Massachusetts, United States
๐Ÿ“ New York, New York, United States
๐Ÿ“ Philadelphia, Pennsylvania, United States
๐Ÿ“ Philadelphia, Pennsylvania, United States
๐Ÿ“ Ciudad autรณnoma de Buenos Aires, Buenos Aires, Argentina
๐Ÿ“ Ciudad Autรณnoma de Buenos Aires, Caba, Argentina
๐Ÿ“ Rosario, Santa Fe, Argentina
๐Ÿ“ Rosario, Santa Fe, Argentina
๐Ÿ“ Macquarie University, New South Wales, Australia
๐Ÿ“ Westmead, New South Wales, Australia
๐Ÿ“ Brisbane, Queensland, Australia
๐Ÿ“ Murdoch, Western Australia, Australia
๐Ÿ“ Vancouver, British Columbia, Canada
๐Ÿ“ Quรฉbec, Quebec, Canada
๐Ÿ“ Santiago, Region M. De Santiago, Chile
๐Ÿ“ Santiago, Region M. De Santiago, Chile
๐Ÿ“ Santiago, Region M. De Santiago, Chile
๐Ÿ“ Viรฑa del Mar, Valparaiso, Chile
๐Ÿ“ Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
๐Ÿ“ Taichung, Taiwan
๐Ÿ“ Taipei, Taiwan
๐Ÿ“ Cambridge, Cambridgeshire, United Kingdom
๐Ÿ“ London, London, City Of, United Kingdom

๐Ÿ“‹ Eligibility Criteria

Description

    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 โ‰ค2 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 โ‰ค12 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 March 2024
  • First Submitted that Met QC Criteria 6 March 2024
  • First Posted 12 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024