History of active malignancy; patients with a history of cancer that has been adequately treated and are free of disease recurrence for years or more are allowed to participate; patients with non-melanoma skin cancers or carcinoma in situ of the bladder that have been adequately excised are eligible to participate Patient must be disease-free >= years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< ) managed with observation that has been stable for at least months A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm History of second malignancy within years of enrollment except for the following: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer or other localized malignancy which has been adequately treated Adequately treated non-melanoma skin cancer OR Patients who have a history of another type of cancer diagnosed within the past years, with the exception of adequately treated non-melanoma skin cancer curatively treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast. Patients with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer; patients with other non-mammary malignancies must have been disease-free for at least years Prior or concomitant malignancies within years prior to screening, with the exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated breast cancer in situ, and localized prostate cancer stage Tc, provided that the patient underwent curative treatment and remains relapse free. adequately treated non-melanoma skin cancer, No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least years Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least years elapsed since the diagnosis of the other primary malignancy. Concurrent active malignancy, other than adequately treated non-melanoma skin cancer, other noninvasive carcinoma, or in situ neoplasm; a subject with previous history of malignancy is eligible, provided that he/she has been disease-free for > years History of other malignancies within the past years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtained History of any other malignancy within years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer and/or subjects with indolent second malignancies are eligible Any active malignancy, other than RCC, for which chemotherapy or other anti-cancer therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least years will be permitted. Patients with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least years Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least years elapsed since the diagnosis of the other primary malignancy. Malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer and patients with prior history of malignancy who have been disease free for more than years are eligible. Concurrent malignancies that are expected to alter life expectancy (e.g., NSCLC, etc.) or that may interfere with assessment of prostate cancer (e.g., lymphoma involving the periaortic nodes). Patients with adequately treated non-melanoma skin cancer or non-muscle invasive urothelial carcinoma, and patients with prior history of malignancy who have been disease-free for more than years are eligible Prior history of invasive cancer within years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer No evidence of prior malignancy except: adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< ) managed with observation that has been stable for at least months, or any malignancy treated with curative intent continuously disease free for >= years so as not to interfere with interpretation of radiographic response Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm Patient has a concurrent active malignancy; malignancies treated with a curative intent with an expected life expectancy >= years or a non-competing life expectancy risk are eligible (i.e. adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, early stage breast cancer, treated prostate cancer or any other cancer from which the patient has been disease free for >= years) Patient has a history of other malignancy treated with curative intent within the previous years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than years prior to initiating current study treatment, and there is no evidence of recurrent disease. Have been diagnosed with another primary malignancy within the past years (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer, which are allowed within years). Prior malignancy unless curatively treated and disease-free for > years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade endometrial cancer allowed. Previous malignant disease within the last years with the exception of adequately treated non-melanoma skin cancer, in situ cancer, or other cancer Prior malignancy, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for years Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer. A second active malignancy except adequately treated non-melanoma skin cancer or other non-invasive or in situ neoplasm adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or Prior history of malignancy =< years prior to registration, except for adequately treated non-melanoma skin cancer, adequately treated early stage breast cancer, adequately treated cervical cancer and non-metastatic prostate cancer under clinical control as deemed by treating physician or investigator Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease. Other cancer that required therapy within the preceding years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study Adequately treated non-melanoma skin cancer OR