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Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer.

Primary Objective:
To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC).

The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.

Secondary Objectives:
- To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm.

- To assess the objective response rate (ORR) by iRECIST in each treatment arm.

- Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nrPFS2).

- Radiographic progression-free survival (rPFS) .

- To assess overall survival (OS) in each treatment arm.

- To assess the time to subsequent second-line therapy or death in each treatment arm.

- To assess the rate of cytoreductive nephrectomy in each treatment arm.

- To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression.

- To assess the ORR by RECIST version 1.1 and iRECIST in the primary renal mass.

Protocol Number: 082305
Phase: Phase II
Applicable Disease Sites: Kidney
Drugs Involved: Axitinib
Cabozantinib (XL184)
IPILIMUMAB (MDX-010)
Lenvatinib (E7080/MK-7902)
Opdivo (Nivolumab)
Pembrolizumab (MK-3475)
Principal Investigator: Lara Hathout
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Radiotherapy
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.