A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma

Protocol: 
AAAR5002
Phase: 
II

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma

The purpose of this study is to test the effectiveness (how well the drug
works), safety, and tolerability of different combinations of cancer drugs
compared to either nivolumab (also known as OPDIVO™or BMS-936558) and
ipilimumab (also knowns as Yervoy™ or BMS-734016) or one another in subjects
with Renal Cancer.
OPDIVO® (nivolumab) and BMS986016 are types of antibodies (a type of human
protein) used in what’s called immunotherapy. Immunotherapy works by
encouraging the body's own immune system to attack the cancer cells.
Nivolumab is approved for use in multiple countries including the United
States (US, December 2014), the European Union (EU, June 2015), and Japan
(July 2014) has been approved by the FDA for treatment of advanced melanoma
(a type of skin cancer), advanced kidney cancer, and advanced non-small cell
lung cancer. Ipilimumab is approved by the US Food and Drug Administration
(FDA), the European Medicines Agency (EMA) and other health authorities for
the treatment of melanoma.

Are you Eligible? (Inclusion Criteria)

Participants must be able to give consent, willing and able to comply with
scheduled treatments, and provide consent for 3 mandatory tumor biopsy
samples

All participants must have:
- advanced or metastatic RCC (renal cell carcinoma)
- prior treatment with IL-2, INF or radiotherapy that ended 4 weeks prior to
randomization

Specialty Area(s)