Phase II Randomized Double-Blind Trial of PF-04518600, an OX40 Antibody, in Combination with Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients with Metastatic Renal Cell Carcinoma


Patients with the most common type of kidney cancer are initially treated with VEGF targeting drugs such as sunitinib and pazopanib, among others. Once the cancer develops resistance, the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as nivolumab. Unfortunately, no treatment strategy works forever and inevitably there is a need to change treatment once again. Patients who have had both VEGF targeting drugs and immunotherapy are typically treated with another VEGF targeting agent, although no drug has been found to provide the best outcome in this setting. This study proposes to give such patients axitinib. In addition, this study proposes to investigate whether the addition of an experimental drug, also working on the immune system, would improve the outcomes for patients. Since this is an experiment and the experimental drug is not proven to be effective, half of the patients will receive the experimental drug, i.e. OX40-Ab and the other half will receive placebo. The treatment assignment is decided at random. The OX40-Ab was studied in various cancers and was found to be safe. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) kidney cancer and have been treated with anti PD1/PDL1 immunotherapy in the past, this trial may be a treatment option.

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Palabras clave: Metastatic kidney cancer, metastatic renal cell carcinoma, axitinib, OX40 Antibody

Sitios de estudio

USC Norris Comprehensive Cancer Center 90033

  • Men & Women
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¿Qué hay involucrado?

Duración del ensayo
  • Treatment will continue as long as treatment side effects are manageable, and patients are benefiting from the treatment.

Número de visitas
  • Screening visits and bi-weekly infusions.

  • Patients may need to be started on medication for high blood pressure.

  • There are no financial compensations offered on this study.

Cobertura de gastos médicos
  • Some tests and procedures are done only because of the research. The study will pay for tests and procedures that are done only because you are in this study. Some tests and procedures are done for your routine health care, and you would receive them even if you were not participating in this study. You and/or your health plan/insurance will be billed for the tests and procedures you need for routine health care while you are in this study. You will be billed in the same way as if you were not in a study. You will be responsible for any co-payments and deductibles required by your insurance. Some health plans/insurance companies will not pay these costs for people taking part in studies. Check with your health plan/insurance company to find out what they will pay for. Additional information is provided prior to enrollment.

Why participate?

If you have previously been treated with immunotherapy for advanced renal cell carcinoma and your cancer is not responding to treatment, this study may offer a treatment option. You and your physician may discuss the suitability of this study and determine whether you should pursue this as an option.


Criterios de inclusión

  • Must have metastatic renal cell carcinoma previously treated with a PD1/PDL1 antibody

Criterios de exclusión

  • Other cancers actively under treatment or rheumatologic disorders such as rheumatoid arthritis and lupus.

Participating Sites

This trial is available at*:
University of Southern California, Norris Comprehensive Cancer Center
University of Southern California, Los Angeles County Hospital
University of Virginia
University of Pittsburgh

*This list is updated as new sites join this study.

Equipo del Programa

Investigador Principal
Sarmad Sadeghi, MD, PhD

For questions about this study, contact:

  • Clinical Research Nurse Coordinator Cheryl Kefauver, RN, CCRP
  • USC/Norris Comprehensive Cancer Center Clinical Investigations Support Office
  • 323-865-0845
  • Quality Assurance Program Administrator/Multi-Site Coordinator Grace Kim
  • USC/Norris Comprehensive Cancer Center Clinical Investigations Support Office
  • 323-865-3122

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