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Phase 2 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

Clinical Trial Details

This clinical trial is for men and women age 18 and older with Renal Cell Carcinoma to check safety and tolerability of PF-045118600 (an OX40 Antibody) in combination with Axitinib versus Axitinib in Immune-Checkpoint inhibitor exposed patients. 
    
Renal cell carcinoma is a type of kidney cancer that affects mainly elderly population. Immunotherapy is a promising and fast expanding field of research and has proven its clinical potential in many types of cancers such as melanoma, bladder cancer, lung cancer and renal cell carcinoma. 

Current treatments can be effective if disease is detected at early stage but usually disease is detected only when it is already advanced. Therefore, there is a need to find more effective treatments with fewer side effects. 

OX40 Ab (PF-045118600) stimulates the immune system and may stop cancer cells from growing. There are clinical and nonclinical observations that OX40 Ab and Axitinib combined therapy may produce superior antitumor activity compared to one drug alone. 

Study Arms: Arm 1 (Axitinib + OX40 Ab) and Arm 2 (Axitinib + placebo) 

  • Placebo is a blank pill/tablet/infusion that looks like a medication but contains no medicine. 
  • Patients will take medications both orally and intravenous (IV) infusion for 14-day cycles. 
  • All patients will be followed for survival until end of the study or until sponsor ends the study. 
  • Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. 
Key Eligibility: 
  • Open to men and women 18 years and older 
  • Pathologically confirmed renal cell carcinoma 
  • Metastatic stage of Renal Cell Carcinoma 
  • Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1806019342

ClinicalTrials.gov:

NCT03092856

Status

Open to Enrollment

Age Group

Adult

Sponsor