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Study of Combination Therapy for Renal Cell Carcinoma

Clinical Trial Title: 
Clinical trial with combination therapies as a first line treatment in locally advanced or metastatic renal cell carcinoma.
Clinical Trial Protocol ID: 
16071202
Clinical Trial Investigator Name: 
Nicklas Pfanzelter, MD
Clinical Trial Protocol Description: 

To provide combination therapies as a first line treatment for patients with locally advanced or metastatic renal cell carcinoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have histologically confirmed diagnosis of renal cell carcinoma with clear cell component with or without sarcomatoid features.
  • Have locally advanced/metastatic disease (i.e., Stage IV renal cell carcinoma per American Joint Committee on Cancer) or have recurrent disease.
  • Have measurable disease per RECIST 1.1 as assessed by the investigator /site radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have received no prior systemic therapy for advanced renal cell carcinoma.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had major surgery within 4 weeks prior to randomization or radiation therapy within 2 weeks prior to randomization, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
  • Have had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD -L1, IL-2R, and GITR.
  • Have received prior therapy with VEGF/VEGFR or mTOR targeting agents. Note: Prior neoadjuvant/adjuvant therapy of these targeted agents is acceptable if completed > 12 months prior to randomization.
  • Have a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Kidney and Urinary System Disorders
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC