Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination with Sunitinib in Patients with TKIs-resistant RCC

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.

2. Be greater than or equal to 18 years of age on day of signing informed consent.

3. Have measurable disease based on RECIST 1.1

4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG)Performance Scale

5. Demonstrate adequate organ function

6. Female subject of childbearing potential should have a negative urine or serumpregnancy test within 72 hours prior to receiving the first dose of studymedication.

7. Subjects of childbearing potential should be willing to use 2 methods ofcontraception for the course of the study through 120 days after the last dose ofstudy medication

8. Male subjects without a previous vasectomy should agree to use an adequate method ofcontraception (i.e. abstinence, condom with spermicidal foam/gel/film/cream)starting with the first dose of study therapy through 120 days after the last doseof study therapy.

9. Subjects have archival tumor tissue available or are willing to undergo a baselinebiopsy prior to treatment.

10. Subjects must have a life expectancy of at least 6 months.

Exclusion Criteria:

1. Is currently participating and receiving study therapy or has participated in astudy of an investigational agent and received study therapy or used aninvestigational device within 4 weeks of the first dose of treatment.

2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 7 days prior to the first dose oftrial treatment.

3. Has active Bacillus tuberculosis (TB)

4. Has a known additional malignancy that is progressing or requires active treatment.Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma ofthe skin that has undergone potentially curative therapy or in situ cervical cancer.

5. Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.

6. Has an active infection requiring systemic therapy.

7. Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with thesubject's participation for the full duration of the trial, or is not in the bestinterest of the subject to participate, in the opinion of the treating investigator.

8. Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.

9. Is pregnant or breastfeeding, or expecting to conceive or father children within theprojected duration of the trial, starting with the pre-screening or screening visitthrough 120 days after the last dose of trial treatment.

10. Has a known history of Human Immunodeficiency Virus (HIV)

11. Has known active Hepatitis B or Hepatitis C

12. Has received a live vaccine within 30 days of planned start of study therapy