Kidney Cancer Research

For enrollment information involving the following trials, please contact a member of our research support staff.

ECOG-PROSPER

Genentech


ECOG-PROSPER

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Inclusion Criteria:

  • Patients with newly diagnosed higher and risk RCC of any histology, including sarcomatoid or (if preoperative biopsy was uninformative) — "unknown" histology. RCC must have been confirmed by biopsy within four months prior to randomization in order to avoid exposing patients to neoadjuvant nivolumab who clearly have a benign lesion or another type of cancer. If the biopsy clearly demonstrated a benign condition or a different type of cancer, the patient is not eligible to be randomized.

  • Clinical stage ≥ T2NxM0 disease or TanyN+ disease for which radical or partial nephrectomy is planned.

  • Patients must have no clinical or radiological evidence of distant metastases (M0).

  • No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted.

  • ECOG Performance Status: 0 or 1.

Exclusion Criteria

  • Patient with prior history of RCC that was resected with curative intent within the past 5 years.

  • Other current malignancies
    – Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years prior to the time of registration and they are not receiving any current treatment.
    – Prior or current prostate cancer.

Principal Investigator: Viraj Master, MD, PhD

Co-Investigators & Collaborators: Kenneth Ogan, MD, Department of Hematology and Medical Oncology: Mehmet Bilen, MD, Bradley Carthon, MD, PhD, Bassel El-Rayes, MD, David Lawson, MD


Genentech

Atezolizumanb (Anti-RD-L1 Antibody) as Adjuvant Therapy in Patients with Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

Inclusion Criteria:

  • Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology (sarcomatoid differentiation regardless of the primary epithelial subtype) that has not been previously treated in the adjuvant or neoadjuvant setting.

  • Patients with localized disease with T2 Grade 4, T3a Grade 3 – 4, T3b/c any grade, T4 any grade, and TxN + any grade are eligible.

  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than four weeks prior to randomization.

  • Radical or partial nephrectomy with lymphadenectomy in select patients; must have negative surgical margin.

  • ECOG performance status of ≤1.

Exclusion Criteria

  • Malignancies other than RCC within five years prior to Cycle 1, Day 1 (exclusions apply, please check study protocol).

  • Bilateral synchronous tumors with inheritable forms of RCC, including von Hippel-Lindau.

  • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within three weeks prior to initiation of study treatment. Treatment with any other investigational agent or participation in another clinical study.

  • CNS metastases or leptomeningeal disease.

Principal Investigator: Viraj Master, MD, PhD

Co-Investigators & Collaborators: Mehmet Bilen, MD (Department of Hematology and Medical Oncology), Mehrdad Alemozaffar, MD, Kenneth Ogan, MD

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