History of another primary malignancy except for \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)Xx_NEWLINE_xXPatients with prior malignancies, except treated non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative surgery without chemotherapy/radiation therapy > 5 years previously will be allowed. Cancer treated with curative surgery < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.Xx_NEWLINE_xXPatients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years.Xx_NEWLINE_xXPatients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancerXx_NEWLINE_xXHistory of prior malignancy except adequately treated basal cell or squamous cell skin cancer or adequately treated, with curative intent, cancer from which the patient is currently in complete remission per Investigator's judgment; patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligibleXx_NEWLINE_xXIndividuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy and did not receive prior chemotherapy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade lesions such as incidental appendix carcinoid, or any other cancer from which the patient has been disease and treatment free for two years; prostate cancer patients on active surveillance are eligibleXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; exception: patients with known history of colon cancer, cancer of the pancreas, or any cancer known to harbor an activating retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) mutation are ineligible regardless of stage or time since diagnosisXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years; men receiving active surveillance for prostate cancer may also be enrolledXx_NEWLINE_xXPatients with second primary malignancy, EXCEPTIONS are: \r\n* Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma\r\n* Other solid tumors and lymphomas (without bone marrow involvement) diagnosed >= 5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was appliedXx_NEWLINE_xXNo other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer; stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five yearsXx_NEWLINE_xXPatients must NOT have previous or concurrent malignancy within 2 years; exceptions are made for patients who meet any of the following conditions:\r\n* Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer OR\r\n* Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 yearsXx_NEWLINE_xXNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three yearsXx_NEWLINE_xXPatient must be disease-free >= 3 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 =< 6) managed with observation that has been stable for at least 6 monthsXx_NEWLINE_xXPatients must not have other current malignancies:\r\n* Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years prior to the time of registration and they are not receiving any current treatment\r\n* Prior or current prostate cancer is excluded\r\n** A history of superficial Ta urothelial cancer is permitted (not being currently treated) but T1 or greater disease is excludedXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated in situ cancer, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXNo other prior malignancy is allowed except, for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligibleXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years of treatment start, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXPatients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXPrevious or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXPatients diagnosed or treated for malignancy other than MCL are not eligible unless they meet one of the following exceptions:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before registration and felt to be at low risk for recurrence by the treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 solid tumor malignancies who are without evidence of disease, or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollmentXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies who have been disease-free for at least 5 years; or individuals with another malignancy that are deemed by the investigator to be at low risk for clinically meaningful recurrence (example [ex.] cervical cancer in situ, definitively treated early stage prostate cancer [confined to prostate with Gleason 6 or below], definitely treated breast ductal or lobular carcinoma in situ, basal cell or squamous cell carcinoma of the skin)Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years; individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomasXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated for cure within the past 5 years: cervical cancer in situ; basal cell or squamous cell carcinoma of the skin; or carcinoma in situ of the bladder, vocal cord, or breastXx_NEWLINE_xXHistory of any second malignancy in the last 5 years; subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible; subjects with other malignancies are eligible if they have been continuously disease free for at least 5 yearsXx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ (DCIS); stage 1, grade 1 endometrial carcinoma; or, other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ? 5 yearsXx_NEWLINE_xXCervical cancer in situXx_NEWLINE_xXHistory of other malignancy within the past 2 years prior to first dose of AMG 757 except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for . 2 years before first dose of AMG 757 and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated in situ cancer without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer Adequately treated urothelial papillary noninvasive carcinomaXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer or breast cancer under control with hormone therapy, or other cancer from which the subject has been disease free for at least 2 years.Xx_NEWLINE_xXPrior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: a) if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) if diagnosed with the following cancers and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior history of other malignancy except:\r\n* Basal cell carcinoma of skin\r\n* Cervical intra-epithelial neoplasia\r\n* Other cancer curatively treated with no evidence of disease for at least 2 yearsXx_NEWLINE_xXPatients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXConcurrent malignancy or a malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer; participants with malignancies less than 3 years prior to registration may be considered eligible after discussion with the principle investigatorXx_NEWLINE_xXPrior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomasXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXConcurrent malignancy or malignancy within 3 years of study entry, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or treated cervical cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR if the other primary malignancy is neither currently clinically significant nor requiring active interventionXx_NEWLINE_xXAny other invasive malignancy from which the patient has been disease-free for less than 5 years with the exception of curatively treated basal or squamous cell skin cancerXx_NEWLINE_xXPrior malignancy (other than non-invasive malignancy including in situ cervical cancer, Bowen's disease or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before randomizationXx_NEWLINE_xXIndividuals with a recent history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years OR are deemed by the investigator to be at low risk for recurrence of that malignancy; 2) individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrevious or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skinXx_NEWLINE_xXHistory of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXAnother malignancy excluding basal cell skin cancerXx_NEWLINE_xXPatient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situXx_NEWLINE_xXEvidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).Xx_NEWLINE_xXOther active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situXx_NEWLINE_xXHistory of a concurrent or second malignancy, except for adequately treated local basal cell or squamous cell carcinoma of the skin, adequately treated superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for ?5 years.Xx_NEWLINE_xXMalignancies within the past 3 years excluding adequately treated basal or squamous cell carcinomas of the skin without local or distant metastasesXx_NEWLINE_xXPrior history of solid tumor malignancy diagnosed within the last three (3) years of study enrollment excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment)Xx_NEWLINE_xXHistory of another malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical or breast carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ?2 years.Xx_NEWLINE_xXParticipant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.Xx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: History of other malignancy which could affect compliance with the protocol or interpretation of results; history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed; subjects with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >= 2 years prior to cycle 1, day 1; subjects with localized prostate cancer that has been treated with curative intent will be allowedXx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Part II: Individuals with a history of a different malignancy are ineligible except for the following circumstances:\r\n* They have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Individuals with the following cancers are eligible if diagnosed and curatively treated within the past 5 years: cervical cancer in situ, and basal or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with other active malignancies are ineligible unless they have been disease-free for at least two years or are deemed by the investigator to be at low risk for recurrence or progression of that malignancy; patients with a history of cervical cancer in situ or basal cell or squamous cell carcinoma of the skin that have been adequately treated and do not require further therapy (hormone therapy is allowed) are eligibleXx_NEWLINE_xXMalignancies within the past 3 years excluding adequately treated basal or squamous cell carcinomas of the skin without local or distant metastasesXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated for cervical cancer in situ or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXPrior malignancy requiring systemic therapy within the last 5 years except for treated basal or squamous cell skin cancer; history of low-grade malignancies with limited potential to progress as determined by the primary investigator may be enrolledXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason ? grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years.Xx_NEWLINE_xXPrior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > 5 years previously will be allowed. Cancer treated with curative intent < 5 years, which is in remission, will be reviewed on a case-by-case basis by the Protocol Officer or one of the Protocol Chairs.Xx_NEWLINE_xXPatients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > 5 years.Xx_NEWLINE_xXHistory of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 yearsXx_NEWLINE_xXHistory of other malignancies, except: \r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; or if diagnosed and treated within the past 2 years for cervical cancer in situ or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent > 5 years previously will be allowed. Cancer treated with curative intent ? 5 years previously will not be allowed unless approved by the Protocol Chairs and/or Protocol Officer.Xx_NEWLINE_xXAdequately treated cervical carcinoma in situXx_NEWLINE_xXAny other invasive cancer in the past 5 years, except basal cell skinXx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatient with previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for >= 2 yearsXx_NEWLINE_xXPrior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screeningXx_NEWLINE_xXSubject has a history of stage III or greater cancer, excluding prostate cancer; subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening; subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years prior to study screeningXx_NEWLINE_xXPrevious or concurrent malignancy, except: (1) treated basal cell or squamous cell cancer of skin, (2) treated in situ cervical cancer, (3) treated lobular or ductal carcinoma in situ in one breast, (4) treated in situ bladder cancer (Bacillus Calmette-Guerin [BCG] as therapy only) with more than 2 years of remission or (5) any other cancer for which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXMalignancies other than urothelial cancer (UC) within 5 years prior to cycle 1, day 1, with the exception of those with a low risk of metastasis or death treated with expected curative outcome (such as, but not limited to, adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent and absence of PSA relapse, or ductal carcinoma in situ of the breast treated surgically with curative intent) or incidental prostate cancer (T1a, Gleason score =< 6 and PSA < 0.5 ng/mL)Xx_NEWLINE_xXPotential patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia (cervical cancer in situ) may not be enrolled unless it is documented that their previous cancer was treated, they have been disease free for five or more years prior to starting this study and they are in their doctor's judgment at less than 30% risk of relapse of this previous malignancy.Xx_NEWLINE_xXHistory of malignancy in the last 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 3 years.Xx_NEWLINE_xXPrevious or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 yearsXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for >= three yearsXx_NEWLINE_xXPhase II only: No other prior malignancies are allowed except for the following:\r\n* Adequately managed stage 0 (carcinoma in situ), I, or II basal cell or squamous cell carcinoma from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease-free for three years\r\n* Adequately managed stage I or II well differentiated thyroid or prostate cancer is also eligible, wherein the patient is not required to be in complete remissionXx_NEWLINE_xXConcurrent or prior malignancy except for the following:\r\n* Adequately treated basal or squamous cell skin cancer\r\n* Adequately treated stage I or II cancer from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five yearsXx_NEWLINE_xXEvidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).Xx_NEWLINE_xXPrior invasive malignancy of other histology, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or any other malignancy for which the patient does not currently require treatment, and/or has no evidence of disease for >= 2 yearsXx_NEWLINE_xXEvidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)Xx_NEWLINE_xXNo other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years.Xx_NEWLINE_xXPatients with other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of ipilimumab (IP) and of low potential risk for recurrence.\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease.Xx_NEWLINE_xXHistory of other malignancy(ies) unless\r\n* The participant has been disease-free for at least 5 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\r\n* The only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXARM I&II: Patients must have no concurrent malignancy except curatively treated early stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease free for >= 3 yearsXx_NEWLINE_xXPrior or concurrent malignancy, except for the following:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Cervical carcinoma in situ\r\n* Adequately treated stage I or II cancer from which the subject is currently in complete remission\r\n* Or any other cancer from which the subject has been disease-free for >= 3 yearsXx_NEWLINE_xXOther prior malignancy\r\n* Exceptions:\r\n** Adequately treated basal cell or squamous cell skin cancer\r\n** Any in situ cancer\r\n** Adequately treated stage I or II cancer from which the patient is currently in complete remission, or\r\n** Any other cancer from which the patient has been disease free for at least 3 yearsXx_NEWLINE_xXHistory of another active cancer within 2 years prior to study drug dosing, excluding adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other adequately treated in situ carcinomaXx_NEWLINE_xXHistory prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for ? 2 years prior to initiation of therapy on current study;\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease;\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease;\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy;\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screeningXx_NEWLINE_xXAdequately treated carcinoma in situ without evidence of disease (e.g. cervical cancer in situ).Xx_NEWLINE_xXHistory of second malignancy within 3 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 treatedXx_NEWLINE_xXHistory of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXMust not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ? 3 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXHas multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ?3 yearsXx_NEWLINE_xXAny other malignancy except localized prostate cancer, basal or squamous cell skin cancer, localized cervical cancer or breast cancer that has been curatively treatedXx_NEWLINE_xXHistory of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for ? 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.Xx_NEWLINE_xXHistory of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low risk localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any time (if complete resection was performed) are allowed.Xx_NEWLINE_xXPatients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is allowed.Xx_NEWLINE_xXDiagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ?6) prostate cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following: malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician; or adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; or adequately treated cervical carcinoma in situ without current evidence of disease.Xx_NEWLINE_xXHistory of another primary malignancy within the past 2 years except for:\r\n* Basal cell skin cancer\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)Xx_NEWLINE_xXPrior malignancy (other than in situ cervical cancer, or basal cell or squamous cell carcinoma of the skin), unless treated with curative intent and without evidence of disease for 3 years or longerXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to start of study treatment, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc).Xx_NEWLINE_xXA history of stage III or greater cancer, excluding prostate cancer; basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration; subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years at the time of registrationXx_NEWLINE_xXHas any other malignancy diagnosed within 2 years of screening with the exception of basal or squamous cell skin cancer, or non-invasive cancer of the cervix, or any other cancer deemed by the treating physician to be of low-risk for progression or patient morbidity during the study period.Xx_NEWLINE_xXNo previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past 3 yearsXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or other cancer from which the subject has been disease free for at least 2 yearsXx_NEWLINE_xXMalignancies other than the disease under study within 3 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or low-risk prostate cancer undergoing active surveillance; patients on androgen deprivation therapy as part of adjuvant therapy after radiation for prostate cancer will be allowedXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 2 yearsXx_NEWLINE_xXSubjects with other active malignancy in the past 3 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, in situ cervical cancer, or another early stage cancer that in the discretion of the investigator(s) is currently in complete remission.Xx_NEWLINE_xXHistory of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval;Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 2 years\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Non-metastatic prostate adenocarcinoma, or treated superficial non-invasive bladder cancer\r\n* Adequately treated carcinoma in situ without evidence of disease (eg, cervical cancer in situ)Xx_NEWLINE_xXA malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years, or has a >= 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the Ta urothelial carcinomas).Xx_NEWLINE_xXCuratively treated in situ diseaseXx_NEWLINE_xXPatients with prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least three yearsXx_NEWLINE_xXDiagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated).Xx_NEWLINE_xXNo prior or concurrent malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 yearsXx_NEWLINE_xXHistory of another primary malignancy except for: 1) Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without evidence of disease (e.g., superficial bladder cancer).Xx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to study treatment, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0)Xx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study treatment and low potential for risk of recurrence\r\n* Adequately treated non-melanoma skin cancer of lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXHistory of another primary malignancy except for: A) malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence; B) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; C) adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ; D) synchronous endometrial and ovarian cancer is allowed, provided the endometrial cancer is presumed stage IA/B grade 1/2Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances:\r\n* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease\r\n* >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXPatients who have a history of another type of cancer diagnosed within the past 5 years, with the exception of adequately treated non-melanoma skin cancer curatively treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following:\r\n* Adequately treated basal cell or squamous cell skin cancer,\r\n* In situ cervical cancer,\r\n* Or any other cancer from which the patient has been disease free for at least three yearsXx_NEWLINE_xXMalignancies other than urothelial cancer within 5 years prior to cycle 1 day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (T1/T2a, Gleason score =< 3 + 4, and PSA =< 0.5 ng/mL undergoing active surveillance and treatment naive)Xx_NEWLINE_xXHistory of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXMalignancies other than pancreatic cancer ?5 years prior to Minnelide cycle 1 day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcomes (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer or ductal carcinoma in situ treated surgically with curative intent) or localised prostate cancer treated with curative intent and absence of PSA relapse or incidental prostate cancer (Gleason score ?3 +4 and PSA <10ng/L undergoing active surveillance and treatment naïve).Xx_NEWLINE_xXActive malignancy (other than colorectal carcinoma [CRC]) or a history of prior malignancy within the past 3 years. Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade lesions such as incidental appendix carcinoid, or any other cancer from which the patient has been disease and treatment free for two years are allowed. Prostate cancer patients on active surveillance are eligibleXx_NEWLINE_xXAny active cancer diagnosis (basal or squamous cell cancers allowed) within the last 5 years for which the patient is receiving active therapy or which is untreated; any cancer diagnosis within the last 5 years that is considered “treated” and/ or on surveillance may be included in the trialXx_NEWLINE_xXHistory of other malignancy within the past 3 years with the following exceptions:\r\n*  Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for >3 years before randomization and felt to be at low risk for recurrence by the treating physician\r\n*  Adequately treated non-melanoma skin cancer without evidence of disease at the time of randomization\r\n* Adequately treated cervical carcinoma in situ without evidence of disease at the time of randomization\r\n* Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of randomization\r\n* Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of randomization\r\n* Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease at the time of randomizationXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXPatients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXSubjects with prior history of non-Merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the patient is currently in complete remission per investigator’s judgment; or patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligibleXx_NEWLINE_xXHistory of another primary malignancy within 2 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situXx_NEWLINE_xXConcurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease, e.g., cervical cancer in situ.Xx_NEWLINE_xXMalignancies other than the disease under study =< 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)Xx_NEWLINE_xXHistory of other primary malignancy not in remission for at least 2 years (The following are exempt from the 2-year limit: nonmelanoma skin cancer, definitively treated stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)Xx_NEWLINE_xXPresence of a concurrent malignancy or malignancy diagnosed within 5 years of randomization, with the exception of basal or squamous cell carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, localized prostate cancer treated with curative intent, and stage I colorectal cancer treated with curative resectionXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXOther prior malignancy; EXCEPTIONS:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Any in situ cancer\r\n* Adequately treated stage I or II cancer from which the patient is currently in complete remission, or\r\n* Any other cancer from which the patient has been disease-free for >= at least three years prior to registrationXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.)Xx_NEWLINE_xXHistory prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screeningXx_NEWLINE_xXHistory of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligns without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situXx_NEWLINE_xXAny concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: head and neck cancer in remission, adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXNo active malignancy except for nonmelanoma skin cancer or in situ cervical cancer; patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowedXx_NEWLINE_xXNo prior or concurrent malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 yearsXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXAdequately treated cervical carcinoma in situ without evidence of disease.Xx_NEWLINE_xXAdequately treated breast ductal carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (e.g. basal cell or squamous cell carcinoma of the skin)\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., breast and cervical cancer in situ)Xx_NEWLINE_xXPrevious or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 yearsXx_NEWLINE_xXHistory of other malignancies, except: \r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHas a diagnosed additional malignancy within 3 years prior to first dose of study treatment with the exception of curatively treated in-situ cancerXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for >= 2 years or which will not limit survival to < 2 yearsXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancersXx_NEWLINE_xXHistory of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ; patients with an early stage cancer, now off therapy for at least 3 years may be enrolled with permission of the principal investigator (PI) if that disease is unlikely to interfere with the primary endpoints of this studyXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXCurrent malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.Xx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease\r\n* Adequately treated carcinoma in situ or T1 urothelial cancer without evidence of diseaseXx_NEWLINE_xXPatients with a history of another malignancy within 3 years prior to registration are not eligible for participation, with the following exceptions:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* In situ cervical cancerXx_NEWLINE_xXPrior malignancies within the past 1 year with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate specific antigen (PSA) levelsXx_NEWLINE_xXActive malignancy, other than NSCLC, for which systemic therapy is indicated; history of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for >= 5 years is permittedXx_NEWLINE_xXPatients diagnosed or treated for malignancy other than HCC are not eligible unless they meet one of the following exceptions:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before registration and felt to be at low risk for recurrence by the treating physician.\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXPrior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > 5 years previously will be allowed; cancer treated with curative intent =< 5 years previously will not be allowed unless approved by the PIXx_NEWLINE_xXPrior or concomitant malignancies within 5 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 T1c, provided that the patient underwent curative treatment and remains relapse free.Xx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancersXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancers for which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXHistory of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other malignancies curatively treated with no evidence of disease for ? 2 years.Xx_NEWLINE_xXHistory of a malignancy (other than head and neck cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 yearsXx_NEWLINE_xXDiagnosed or treated for malignancy other than MCL, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 2 years before randomization\r\n* Adequately treated non-melanoma skin cancer or melanoma in situ without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of disease\r\n* Asymptomatic prostate cancer managed with “active surveillance”Xx_NEWLINE_xXHistory of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXPrior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXPrior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free intervalXx_NEWLINE_xXother adequately treated Stage 1 or 2 cancer currently in complete remission;Xx_NEWLINE_xXPrior or concurrent malignancy, except for the following:\r\n* Adequately treated basal cell or squamous cell skin cancer;\r\n* Or any other cancer from which the subject has been disease-free for > 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXCurrent malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.Xx_NEWLINE_xXPrevious malignancy with the following exceptions: adequately treated basal cell carcinoma or squamous cell carcinoma of the skin; any in situ malignancy; adequately treated stage 1 or stage 2 cancer from which the patient is currently in remission; any other cancer from which the patient has been disease-free for 3 yearsXx_NEWLINE_xXNo other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for > 3 yearsXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXNo prior malignancy is allowed except:\r\n* Adequately treated basal cell or squamous cell skin cancer or\r\n* In situ carcinoma of any site or\r\n* Other adequately treated malignancy for which the patient has been disease-free for at least one year (any prior chemotherapy is allowed)Xx_NEWLINE_xXDiagnosis of any second malignancy within the last 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, per investigator’s discretion (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)Xx_NEWLINE_xXNo prior malignancy is allowed except:\r\n* Adequately treated basal cell or squamous cell skin cancer or\r\n* In situ carcinoma of any site or\r\n* Other adequately treated malignancy for which the patient is currently disease free for at least one yearXx_NEWLINE_xXSecond primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 2 years previously with no evidence of recurrenceXx_NEWLINE_xXHistory of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.Xx_NEWLINE_xXPatients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol investigator / lead-sub-investigatorXx_NEWLINE_xXAny malignancies in the 3 years prior to Baseline, excluding basal cell carcinoma, in situ malignancy, low-risk prostate cancer, cervical cancer after curative therapy.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 yearsXx_NEWLINE_xXcuratively treated in-situ cancer, orXx_NEWLINE_xXPrior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXPatients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol chair or co-chairXx_NEWLINE_xXPatients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol sponsor-investigator/lead-sub-investigatorXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 yearXx_NEWLINE_xXCurrent malignancies of another type, with the exception of adequately treated in situ cervical cancer, squamous cell and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients who have a previous or concomitant malignancy are NOT eligible for participation EXCEPT for the following:\r\n* Patients with curatively treated squamous or basal cell carcinoma of the skin or effectively treated carcinoma in situ of the cervix ARE eligible for participation\r\n* Patient who had a stage 1 solid tumor which has been adequately treated with curative intent, and has been in remission for > 1 year\r\n* Patients with a prior solid tumor who have been in remission > 5 years ARE eligible for participationXx_NEWLINE_xXPatients with other known malignancies within the past three years except: i. adequately treated basal or squamous cell skin cancer; ii. carcinoma in situ of the cervix; iii. prostate cancer with Gleason score < 6 with stable prostate-specific antigen (PSA) over the past three months; iv. breast cancer in situ with full surgical resectionXx_NEWLINE_xXMalignancies other than rectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intentXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or other cancer from which the subject has been disease free for at least 2 yearsXx_NEWLINE_xXPreviously 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 2 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated for cure within the past 2 years: cervical cancer in situ, carcinoma in situ of the breast, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo prior malignancies within 5 years, unless treated early stage breast cancer, treated carcinoma in situ of the cervix, resected skin malignancies, or treated prostate cancerXx_NEWLINE_xXOther malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ?5 years.Xx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different invasive malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXAny prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five yearsXx_NEWLINE_xXPatients with adequately treated basal cell or squamous cell carcinoma of the skin, adequately treated non-invasive carcinomas will be eligibleXx_NEWLINE_xXNo other malignancy except for adequately treated basal cell or squamous cell skin cancer or cervical cancer in-situXx_NEWLINE_xXany cancer curatively treated > 3 years before randomizationXx_NEWLINE_xXOther prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.Xx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)Xx_NEWLINE_xXHistory of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ? 5 years.Xx_NEWLINE_xXAdequately treated basal cell or squamous cell skin cancerXx_NEWLINE_xXIn situ cervical cancerXx_NEWLINE_xXAdequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXPatient had a malignancy other than multiple myeloma within 3 years before enrollment, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer.Xx_NEWLINE_xXSecond primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligibleXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrevious or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 yearsXx_NEWLINE_xXPatient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situXx_NEWLINE_xX213 History of malignancy other than B-NHL within the past 3 years with the exception of: Malignancy treated with curative intent and with no known active disease present for ? 3 years before enrollment and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.Xx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years.Xx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ? 5 yearsXx_NEWLINE_xXNo prior malignancy is allowed except:\r\n* Adequately treated basal cell or squamous cell skin cancer or\r\n* In situ carcinoma of any site or\r\n* Other adequately treated malignancy for which the patient has been disease-free for at least one year (any prior chemotherapy is allowed)Xx_NEWLINE_xXPrevious or concurrent malignancy within the last 3 years with the exception of adequately treated skin basal or squamous cell with adequate wound healingXx_NEWLINE_xXOther primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)Xx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXHistory of any other prior malignancy; (NOTE: Exception to this are adequately treated non-melanoma skin cancers, any in situ cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years prior to study enrollment)Xx_NEWLINE_xXHistory of another malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXHistory prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screeningXx_NEWLINE_xXPatients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 1 year post diagnosis; patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treatedXx_NEWLINE_xXHistory of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 2 years before the first dose of IP and of low potential risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated carcinoma in situ without evidence of disease.Xx_NEWLINE_xXPatients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol chair or co-chairXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ\r\n* Controlled, superficial bladder carcinoma\r\n* T1a or T1b or T1c prostate carcinoma treated with radiation >= 1 year prior to study enrollment and prostate specific antigen (PSA) within normal limits (WNL) since treatment \r\n* T2a or b prostate carcinoma treated curatively >= 1 year prior to study enrollment and PSA undetectable since curative treatment\r\n* Other early stage cancers that have a minimal chance of recurrence (i.e stage I endometrial cancer, cervical cancer, etc.) may be cleared by the PIXx_NEWLINE_xXDiagnosed or treated for malignancy other than ALL, except: 1) Malignancy treated with curative intent and with no known active disease present for >= 3 years before treatment; 2) Adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ (e.g. cervical, breast) without evidence of disease; 3) or malignancy that in the opinion of the investigator, with concurrence with the MD Anderson Cancer Center (MDACC) investigational new drug (IND) office, is considered cured with minimal risk of recurrence within 3 yearsXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancersXx_NEWLINE_xXHistory of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of study drug and of low potential risk for recurrence;\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or \r\n* Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 5 yearsXx_NEWLINE_xXMalignancies other than colorectal adenocarcinoma within 5 years prior to treatment, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intentXx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to registrationXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXPresence of a malignant disease within the last 12 months, with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, non-melanomatous skin cancer, or malignancies treated with curative intent and no evidence of active disease in prior 12 months and felt to be low risk for recurrence.Xx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years of study screening period, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy except for the following circumstances: if they have been disease-free for at least 2 years prior to starting study drug and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage I or stage II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 3 yearsXx_NEWLINE_xXPatients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of randomizationXx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years; patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic diseaseXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXHistory of prior malignancy except: a) Malignancy treated with curative intent and no known active disease present for ?2 years prior to initiation of current study; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated in situ carcinomas (e.g., cervical, esophageal, breast, etc.) without evidence of disease; d) asymptomatic prostate cancer managed with \watch and wait\ strategy; e) myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screeningXx_NEWLINE_xXDONOR: Malignancy within 10 years prior to donation of marrow, excluding adequately treated squamous cell skin cancer and basal cell carcinoma; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least 10 years at time of marrow harvestXx_NEWLINE_xXIndividuals with a history of a different malignancy are excluded except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible even if diagnosed within the past 3 years, if treated with curative intent: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy and did not receive prior chemotherapy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXAdequately treated carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXConcurrent or prior malignancy except for the following: \r\n* Adequately treated basal or squamous cell skin cancer\r\n* Adequately treated stage I or II cancer from which the patient is currently in complete remission\r\n* Any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXHistory of stage III or greater cancer, except basal or squamous cell skin cancers adequately treated or any other stage I or II cancer adequately treated and disease-free for >= 2 years; incidental findings of stage I or II prostate cancer that is considered to be cured with radical cystoprostatectomy is allowedXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXPatient has other prior or concurrent malignancy (except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, early gastric or GI cancer resected completely by endoscopy procedures or any other cancer from which the patient has been disease free for >= 3 years)Xx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years of starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXMalignancies other than disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia [CLL] Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXSubject has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer)Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXConcurrent other malignancy with the exception of: \r\n* Cutaneous squamous cell and basal carcinomas\r\n* Adequately treated stage 1-2 malignancy\r\n* Adequately treated stage 3-4 malignancy that has been in remission for >= 2 years at the time of registrationXx_NEWLINE_xXPatients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 yearsXx_NEWLINE_xXDiagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy treated with curative intent and with no known active disease present for more than equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies (including but not limited to, cervical, breast) with no evidence of diseaseXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXParticipants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligibleXx_NEWLINE_xXOther prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances:\r\n* Synchronous or metachronous primary non-small cell lung cancers, of lower stage than the cancer for which adjuvant treatment is currently being prescribed\r\n* Disease-free for at least 3 years, and deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin\r\n* Other low grade and good-prognosis cancers such as, but not limited to, ductal carcinoma in situ (DCIS), prostate cancer, carcinoid cancer etc.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following:            \r\n* Adequately treated in situ cancers (stage 0)\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Adequately treated stage I or II cancer from which the patient has been in complete remission or\r\n* Any other cancer from which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXCLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligibleXx_NEWLINE_xXPrior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.Xx_NEWLINE_xXPrior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma, or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.Xx_NEWLINE_xXDiagnosis of any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or melanoma in-situ or low grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (eg, surgery, radiation or castration)Xx_NEWLINE_xXSubject has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or prior ovarian/breast cancer in patients with BRCA associated breast cancer)Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXHistory of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.Xx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two yearsXx_NEWLINE_xXAnother active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 yearsXx_NEWLINE_xXPrior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ (DCIS), or other cancer from which the patient has been disease free for at least 3 yearsXx_NEWLINE_xXHistory of a non-CLL malignancy except for adequately treated in situ, stage 1 or 2 carcinoma in Complete Response (CR), or any other cancer that has been in CR for >=2 years after end of cancer treatment.Xx_NEWLINE_xXPrior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ? 2 years.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXNo previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXAdequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXAdequately treated breast ductal carcinoma in situ without evidence of diseaseXx_NEWLINE_xXOther malignancy except for treated and cured basal or squamous cell skin cancer, cured in situ cancers, or other cancer from which the patient has been disease-free for ? 3 years.Xx_NEWLINE_xXHistory of other malignancy except for adequately treated basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease-free for ? 2 years.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years after surgical treatment.Xx_NEWLINE_xXNo prior malignancy with the exceptions listed below:\r\n* Malignancy treated with curative intent and with no evidence of active disease for more than 3 years prior to screening and felt to be at low risk (< 30%) for recurrence by the treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission per investigators' clinical judgment.Xx_NEWLINE_xXEvidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancersXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0)Xx_NEWLINE_xXHistory of a concurrent or second malignancy, except for: adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; adequately treated Stage 1 or 2 cancer currently in complete remission; any other cancer that has been in complete remission for ? 5 yearsXx_NEWLINE_xXAny prior history of other malignancy besides follicular lymphoma, unless the patient has been free of disease for >= 5 years and felt to be at low risk for recurrence by the treating physician, except:\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of a second cancer, except treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancers for which patients are disease free for at least 3 yearsXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject is considered by his or her physician to have a less than 2-year survival expectationXx_NEWLINE_xXHistory of other malignancies, except: \r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXPatients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or other in situ carcinoma that has been adequately treatedXx_NEWLINE_xXHistory of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ? 2 years at the time of registration.Xx_NEWLINE_xXPrior malignancy (other than bladder cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years of which will not limit survival to < 2 years.Xx_NEWLINE_xXPrevious or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%Xx_NEWLINE_xXPatient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer)Xx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.Xx_NEWLINE_xXPrior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three yearsXx_NEWLINE_xXAny concurrent or previous malignancy within 5 years prior to randomization, except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm.Xx_NEWLINE_xXNo evidence of prior malignancy except: adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for >= 3 years so as not to interfere with interpretation of radiographic responseXx_NEWLINE_xXSubject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasmXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.) Medication-Related Exclusion Criteria:Xx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)Xx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancerXx_NEWLINE_xXCuratively treated basal cell/squamous cell skin cancerXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.Xx_NEWLINE_xXHistory of other malignancies, except: malignancy treated with curative intent and with no known active disease present for >= 5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician, (2) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, (3) adequately treated carcinoma in situ without evidence of disease, or (4) Gleason 6 prostate cancer under observationXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (eg, cervical cancer in situ)\r\n* Adequately treated stage 1 breast or stage 1 low grade endometrial cancerXx_NEWLINE_xXPatient has a concurrent active malignancy; malignancies treated with a curative intent with an expected life expectancy >= 5 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 >= 3 years)Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three yearsXx_NEWLINE_xXNo other active malignancy within 3 years of enrollment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXNo active, second potentially life-threatening cancer; no history of another primary malignancy except for; malignancy treated with curative intent and no known active disease >= 5 years before the first dose of investigation product (IP) and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of previous malignancy (except in-situ cancer or basal or squamous cell skin cancer) within past 3 yearsXx_NEWLINE_xXPrior malignancies within the past 3 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levelsXx_NEWLINE_xXParticipant has had any other malignancy within 5 years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uterus, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment).Xx_NEWLINE_xXPrior malignancy (other than ovarian cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 years.Xx_NEWLINE_xXAny prior history of other malignancy besides FL or marginal zone lymphoma, unless the patient has been free of disease for >= 5 years and felt to be at low risk for recurrence by the treating physician, except:\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other cancer from which the patient has been disease-free for 5 years; patients may have dual primaries of endometrial and ovarian cancerXx_NEWLINE_xXMalignancies within 3 years prior to treatment start, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia [CLL] Rai stage 0, prostate cancer with Gleason score =< 6, and prostate specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXPrior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 yearsXx_NEWLINE_xXPatients with concurrent malignancies or malignancies within 3 years prior to starting study drug (with the exception of tumors common to a single genetic cancer syndrome, i.e. MEN1, MEN2, von Hippel-Lindau [vHL], tuberous sclerosis complex [TSC] etc., or adequately treated, basal cell skin cancer, squamous cell carcinoma, non-melanoma skin cancer or curatively resected cervical cancer)Xx_NEWLINE_xXAdequately treated basal cell or squamous cell skin cancerXx_NEWLINE_xXPrior malignancy (within the last 5 years) except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancerXx_NEWLINE_xXPrior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 years.Xx_NEWLINE_xXNo prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason ? grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three yearsXx_NEWLINE_xXPrevious or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence for at least 5 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior cancers < 3 years, with the exception of in-situ cervical cancer, low grade prostate cancer and basal or squamous cell skin cancersXx_NEWLINE_xXPatients who have a history of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years; patients may have dual primaries of endometrial, ovarian or breast cancerXx_NEWLINE_xXConcurrent other malignancy with the exception of: a) cutaneous squamous cell and basal carcinomas, b) adequately treated stage 1-2 malignancy, c) adequately treated stage 3-4 malignancy that had been in remission for >= 2 years at the time of registrationXx_NEWLINE_xXIndividuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active interventionXx_NEWLINE_xXSubjects with a history of malignancy are not eligible with the exception of the following:\r\n* Malignancy treated within curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated with curative intent within the past 5 years: cervical cancer in situ, localized prostate cancer, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 years.Xx_NEWLINE_xXPatients with prior malignancy except for the following:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* In situ cervical cancer\r\n* Adequately treated stage I or II cancer from which the patient is currently in complete remission and has been disease free for the past 2 years\r\n* Any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXDiagnosis of any non-RCC malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment interventionXx_NEWLINE_xXHistory of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 yearsXx_NEWLINE_xXNo active malignancy except for nonmelanoma skin cancer or in situ cervical cancer; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form)Xx_NEWLINE_xXHistory of another malignancy within the previous 2 years except for the following:\r\n* Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer\r\n* Adequately treated stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 yearsXx_NEWLINE_xXPHASE I: Individuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPHASE II: Individuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 years. Note: these cases must be discussed with the Medical Monitor.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: \r\n* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or \r\n* Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: superficial bladder cancer, basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.Xx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ?5 years.Xx_NEWLINE_xXThe presence of a second malignancy, other than squamous cell carcinoma of the skin or in situ cervical cancer; cancer survivors who have been free of disease for at least one year can be enrolled in this studyXx_NEWLINE_xXPrior malignancy (within the last 5 years) except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances:\r\n* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: breast cancer in situ and basal cell or squamous cell carcinoma of the skin, stage I colon carcinoma confined to a polypXx_NEWLINE_xXPatient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.Xx_NEWLINE_xXPatient has other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for more than 5 yearsXx_NEWLINE_xXOther malignancy within the last 5 years except: adequately treated non-melanomatous skin cancer, curatively treated in situ cervical cancer, ductal carcinoma in situ (DCIS), International Federation of Gynecology and Obstetrics (FIGO) Grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.Xx_NEWLINE_xXMalignancies other than the disease under study within 3 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard of care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score ? 6, and prostate-specific antigen [PSA] ? 10 mg/mL, etc.)Xx_NEWLINE_xXIndividuals with a history of a different active malignancy are ineligible; participants with a history of other malignancies are eligible if they have been disease-free for at least 2 years, not on active treatment, and deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: Prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibilityXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening, and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXDiagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXConcurrent malignancies or invasive cancers diagnosed within the past 3 years, except for adequately treated basal cell cancer of the skin or in situ cancer of the cervixXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; in addition, individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy; no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, low risk localized prostate cancerXx_NEWLINE_xXAdequately treated basal or squamous cell skin cancerXx_NEWLINE_xXAdequately treated stage I or II cancer from which the patient is currently in complete remissionXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of another primary cancer within 3 years prior to enrollment with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situXx_NEWLINE_xXIndividuals with a history of another non-hematologic malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXOther past or current malignancy; subjects who have been free of malignancy for at least 5 years, have a history of completely resected non-melanoma skin cancer, successfully treated in situ carcinoma, adequately treated basal or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years are eligibleXx_NEWLINE_xXPrevious or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 yearsXx_NEWLINE_xXCurrent malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, adequately treated in situ cervical cancer and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.Xx_NEWLINE_xXHistory of other active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ treated curativelyXx_NEWLINE_xXConcurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < 5 yearsXx_NEWLINE_xXHistory of another primary cancer within 3 years prior to day 1 with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the patients with concurrent non-invasive endometrial cancer; individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years, were treated with curative intent, and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrevious or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer for which the patient has been previously treated and the lifetime recurrence risk is less than 30%Xx_NEWLINE_xXHistory of prior malignancy, except: malignancy treated with curative intent and with no known active disease present for >=3 years before randomization; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXIndividuals with the following cancers are eligible if diagnosed and definitively treated prior to study entry: cervical cancer in situ, basal cell or squamous cell carcinoma of the skin; individuals with a history of other malignancy are ineligible unless disease-free for at least 3 years or deemed by the investigator to be at low risk (< 10%) for recurrence of that malignancyXx_NEWLINE_xXHistory of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollmentXx_NEWLINE_xXIndividuals with a history of a different malignancy (other than ALL) are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin; individuals treated for localized, node-negative cancers >= 2 years ago with no evidence of cancer are also considered eligibleXx_NEWLINE_xXPatients with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years; there will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treatedXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with a history of a different malignancy are ineligible except for the following circumstances:\r\n* Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy\r\n* Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years:\r\n** Cervical cancer in situ\r\n** Basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of a malignancy (other than melanoma) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 yearsXx_NEWLINE_xXPatients with prior malignancy will be excluded except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancers from which the patient has been disease-free for at least 5 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, prostate cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXHistory of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancerXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXDiagnosed or treated for malignancy other than the indication under study except for\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study treatment\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXHistory of other malignancy, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHas a history of invasive malignancy ?5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.Xx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)\r\n* Adequately treated stage 1 breast cancerXx_NEWLINE_xXHistory of other malignancy (i.e., excluding disease under study) within 3 years of randomization. Exceptions include: adequately-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated non-metastatic prostate cancer.Xx_NEWLINE_xXPatients with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; patients with treated cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin; patients will not be eligible if they have evidence of other malignancy requiring therapy other than surgery within the last 3 yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-invasive cancer (such as, any in situ cancers), and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXOther active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanomaXx_NEWLINE_xXIndividuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXhistory of any other malignancy treated within the last 5 years, other than squamous or basal cell skin cancer;Xx_NEWLINE_xXPatients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of randomizationXx_NEWLINE_xXDONOR: No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the donor has been disease-free for five yearsXx_NEWLINE_xXAdequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ?2 yearsXx_NEWLINE_xXOther prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.Xx_NEWLINE_xXPrevious history of another cancer within 5 years, except completely removed basal or squamous cell skin cancer.Xx_NEWLINE_xXHistory of a non-CLL malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ? 1 year prior to enrollment, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ? 2 years.Xx_NEWLINE_xXPrior malignancy is NOT allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least five yearsXx_NEWLINE_xXAnother active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 yearsXx_NEWLINE_xXPatients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol principal investigatorsXx_NEWLINE_xXDiagnosed or treated for malignancy other than NHL for which patient will be treated, except: malignancy treated with curative intent and with no known active disease present for >= 3 years before subject registration; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXHistory of another malignancy except for the following: adequately treated local non-melanoma skin cancer; in situ cervical carcinoma; adequately treated, papillary, non-invasive bladder cancer; asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ? 1 year prior to start of study therapy; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ? 2 years.Xx_NEWLINE_xXAny prior or synchronous malignancy (other than breast cancer), except i) Malignancy treated with curative intent and with no evidence of disease for ? 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician ii) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of diseaseXx_NEWLINE_xXMalignancies other than SCLC within 2 years prior to administration of study treatment with the exception of those with a negligible risk of metastases or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or breast, basal or squamous cell skin cancer, or localized prostate cancer treated definitively)Xx_NEWLINE_xXAdequately treated stage I cancer from which the subject is currently in remissionXx_NEWLINE_xXPrior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ? 2 years or which will not limit survival to < 2 years.Xx_NEWLINE_xXMalignancy within 3 years or active disease requiring treatment other than the target cancer. The exceptions are prostate cancer (Gleason grade < 6 with normalized PSA levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin cancer.Xx_NEWLINE_xXHistory of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ? 1 year prior to enrollment, adequately treated Stage 1 or 2 non-pancreatic cancer currently in complete remission, or any other non-pancreatic cancer that has been in complete remission for ? 5 yearsXx_NEWLINE_xXNo previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past five yearsXx_NEWLINE_xXOther prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.Xx_NEWLINE_xXOther prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.Xx_NEWLINE_xXAdequately treated carcinoma in situ without evidence of disease.Xx_NEWLINE_xXHistory of other malignancies within the past year except for treated basal cell or squamous cell skin cancer or in situ cervical cancerXx_NEWLINE_xXanother malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancerXx_NEWLINE_xXOther malignant diseases within 5 years of trial registration (except for adequately treated basal-cell or squamous cell skin cancer, in situ cervical cancer and any other cancer from which patients has been disease-free for 3 years)Xx_NEWLINE_xXHistory of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 yearsXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of disease\r\n* Skin-limited Kaposi sarcoma that has not required systemic treatment within 6 months prior to study enrollmentXx_NEWLINE_xXPatients with presence of concurrent or active malignant disease (other than disease under study) within the last 12 months with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer.Xx_NEWLINE_xXadequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, orXx_NEWLINE_xXother adequately treated Stage 1 or 2 cancer currently in complete remissionXx_NEWLINE_xXHistory of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 yearsXx_NEWLINE_xXHistory of another primary malignancy not in clinical remission; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, or localized prostate cancer with prostate-specific antigen (PSA) < 1 ng/mlXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five yearsXx_NEWLINE_xXMalignancies other than metastatic colorectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intentXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five yearsXx_NEWLINE_xXOther cancer curatively treated with no evidence of disease for at least 5 yearsXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai stage 0, prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc.)Xx_NEWLINE_xXPatients may not have a history of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five yearsXx_NEWLINE_xXDiagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.Xx_NEWLINE_xXPatients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.Xx_NEWLINE_xXAnother known malignancy that is progressing or requires active treatment (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.Xx_NEWLINE_xXOther malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer if protocol criteria are metXx_NEWLINE_xXIndividuals with a history of other malignancies are ineligible unless they:\r\n* Have been disease-free for at least 5 years or are deemed by the investigator to be at low risk for recurrence or progression of that malignancy\r\n* Have the following cancers if diagnosed and treated within the past 5 years: cervical cancer in situ and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrior history of malignancy =< 3 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 investigatorXx_NEWLINE_xXPatient has a history of invasive malignancy other than Primary Central Nervous System Lymphoma (PCNSL). Patients are eligible, if they are disease-free for at least 3 years and deemed to be at low risk for recurrence by the investigator. Patients diagnosed with cervical cancer in situ, basal cell or squamous cell carcinoma of the skin and treated within the past 3 years are eligible.Xx_NEWLINE_xXHistory of second or other primary cancer with the exception of: 1) curatively treated non-melanomatous skin cancer; 2) curatively treated cervical or breast carcinoma in situ; or 3) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years.Xx_NEWLINE_xXAdequately treated carcinoma in situ without evidence of disease.Xx_NEWLINE_xXHistory of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancerXx_NEWLINE_xXHistory of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ? 5 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXPrior cancer diagnosis is allowed if patient is disease-free for >= 3 years, or disease free for < 3 years for treated basal cell/ squamous cell skin cancer or in situ cervical cancerXx_NEWLINE_xXMalignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intentXx_NEWLINE_xXUnderlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination of adverse events. This includes other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancer; or any other cancer from which the patient has been disease-free for at least 3 years.Xx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, ductal carcinoma in situ (DCIS), stage I prostate cancer, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrevious or current malignancies of other histologies within the last 3 years (yrs) prior to randomization; with the exception of cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancerXx_NEWLINE_xXHistory of prior malignancy, with the exception of the following:\r\n* Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease\r\n* Adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xXHistory of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ? 3 years.Xx_NEWLINE_xXMalignancies other than CRC within 5 years prior to randomization, except for those with a minimal risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ treated surgically with curative intentXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXOther prior malignancy; adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for > 5 years are allowedXx_NEWLINE_xXOther malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage </= 1B.Xx_NEWLINE_xXHistory of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ?2 yearsXx_NEWLINE_xXNo prior malignancy is allowed except:\r\n* Adequately treated basal cell or squamous cell skin cancer or\r\n* In situ carcinoma of any site or\r\n* Other adequately treated malignancy for which the patient is currently disease free for at least one yearXx_NEWLINE_xXSecond malignancy within past three years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over the past three months, breast cancer in situ with full surgical resection, treated medullary or papillary thyroid cancerXx_NEWLINE_xXMalignancies other than SCCHN within 5 years prior to enrollment, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix or skin (e.g., melanoma in situ) or indolent prostate cancerXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXSecond primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrenceXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXPrior or second malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or other cancer for which the subject has received curative therapy at least 3 years prior to study entry.Xx_NEWLINE_xXPatient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).Xx_NEWLINE_xXHave an additional malignancy diagnosed within 5 years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ.Xx_NEWLINE_xXHistory of other malignancy, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years prior to registration and felt to be at low risk for recurrence by the treating physician\r\n* Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of diseaseXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they were treated with curative intent, are currently disease-free and have an estimated risk of recurrence less than 10% at the time of study entry. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with other known active malignancy (excluding adequately treated basal cell/squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease free for 2 years)Xx_NEWLINE_xXadequately treated basal cell or squamous cell skin cancerXx_NEWLINE_xXPatient has any tumor progression after definitive GBM resection/ biopsy, except for the transformation from previous low grade glioma. Patient with a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer)Xx_NEWLINE_xXPatients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXDuring Phase II enrollment: the presence of a second malignancy within the last 2 years, other than squamous cell carcinoma of the skin or in situ cervical cancer; cancer survivors who have been free of disease for at least two years can be enrolled in this studyXx_NEWLINE_xXHas a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 yearsXx_NEWLINE_xXNo history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free intervalXx_NEWLINE_xXThe participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.Xx_NEWLINE_xXPatients with a history of any other cancer (except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligibleXx_NEWLINE_xXHistory of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible;Xx_NEWLINE_xXThe participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last 3 yearsXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years.Xx_NEWLINE_xXSecond primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence; prior low grade [Gleason score less than 6] localized prostate cancer is allowed).Xx_NEWLINE_xXPrior or concurrent malignancies (including myelodysplasia) except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent < 5 years previously will not be allowed unless approved by the protocol chair; cancer treated with curative intent > 5 years previously will be allowedXx_NEWLINE_xXPatients with prior malignancies except resected basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent more than 5 years previously will be allowedXx_NEWLINE_xXHistory of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible.Xx_NEWLINE_xXMalignancies other than urothelial cancer (UC) within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent and absence of PSA relapse, or ductal carcinoma in situ of the breast treated surgically with curative intent) or incidental prostate cancer\r\n* Patients are considered to be free of active malignancy if they have completed therapy and have a < 30% risk of relapseXx_NEWLINE_xXHistory of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)Xx_NEWLINE_xXPrior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 yearsXx_NEWLINE_xXPrior cancer diagnosis is allowed if patient is disease-free for >= 3 years, or disease free for < 3 years for treated basal cell/squamous cell skin cancer or in situ cervical cancerXx_NEWLINE_xXPatient has other prior or concurrent malignancy (except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, early gastric or GI cancer resected completely by endoscopy procedures or any other cancer from which the patient has been disease free for >= 3 years)Xx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five yearsXx_NEWLINE_xXHistory of a different malignancy except for the following circumstances:\r\n* Disease?free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (< 5 %)\r\n* Cervical cancer in situ and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXIndividuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two yearsXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances: individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or if they are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: breast cancer in situ, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXTreated for any other cancerXx_NEWLINE_xXMalignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) Exclusion Criteria Related to MedicationsXx_NEWLINE_xXHistory of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;Xx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 1 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease\r\n* Low-risk prostate cancer after curative surgeryXx_NEWLINE_xXHistory of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligibleXx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease\r\n* Low-risk prostate cancer on active surveillanceXx_NEWLINE_xXHistory of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and or low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situXx_NEWLINE_xXDiagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated)Xx_NEWLINE_xXA prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation)Xx_NEWLINE_xXPatients with prior malignancies are excluded unless treated with curative intent and known to be free of disease for at least 2 yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ [DCIS], adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for > 5 yearsXx_NEWLINE_xXOther prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer) from which the patient has been disease-free for at least two yearsXx_NEWLINE_xXPrior or current malignancy other than: \r\n* breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or\r\n* basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or \r\n* other cancer for which the patient has been disease free for >= 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five yearsXx_NEWLINE_xXNo other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for > 5 yearsXx_NEWLINE_xXPatients with prior malignancies, except resected non-melanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.Xx_NEWLINE_xXHistory of active malignancy in the past 2 years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score 6 or less)Xx_NEWLINE_xXHistory of active malignancy within the past 5 years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score 6 or less)Xx_NEWLINE_xXEXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): History of other malignancies, except: \r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n Adequately treated carcinoma in situ without evidence of diseaseXx_NEWLINE_xXPatients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent > 5 years will be allowed; cancer treatment with curative intent =< 5 years will not be allowedXx_NEWLINE_xXPrior history of or current malignancy other than adequately treated skin cancer (squamous cell cancer or basal cell carcinoma)Xx_NEWLINE_xXAny prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.Xx_NEWLINE_xXActive malignancy within the past 5 years (excluding HCC, basal/squamous cell skin cancer, or prostate cancer with a Gleason score 6 or less)Xx_NEWLINE_xXParticipant has or has had other cancer(s) within 3 years of study; however, in situ breast, in situ cervical, and basal cell/squamous cell skin cancers are allowedXx_NEWLINE_xXMalignancies other than the disease under study within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g. prostate cancer with Gleason score =< 6, and prostate-specific antigen [PSA] =< 10 mg/mL, etc)Xx_NEWLINE_xXHave a history of other malignancy(ies) unless: They have been disease-free for at least 5 years and are deemed by the treating investigator to be at low risk for recurrence of that malignancy, or the only cancer they have had is cervical cancer in situ, or basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXNo prior history of other malignancies within past 5 years (besides breast cancer); individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin; no concurrent malignancy or other serious medical condition as deemed by the investigator; patients with history of contralateral breast cancer are not eligibleXx_NEWLINE_xXNo history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 yearsXx_NEWLINE_xXA malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancer for which the subject has not been disease-free for 5 yearsXx_NEWLINE_xXHistory of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ? 5 years. Prior in situ cancer of the breast is not a reason for exclusion.Xx_NEWLINE_xXPatients with prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent > 5 years previously will be allowed; cancer treated with curative intent < 5 years previously will not be allowed unless approved by the protocol officer or one of the protocol chairsXx_NEWLINE_xXPatients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.Xx_NEWLINE_xXThere must be no previous or concurrent malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease free for five yearsXx_NEWLINE_xXHistory of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent)Xx_NEWLINE_xXPatients with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXCuratively treated in situ diseaseXx_NEWLINE_xXMalignancies other than triple negative breast cancer (TNBC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)Xx_NEWLINE_xXHistory of other malignancies, except: malignancy treated with curative intent and with no known active disease present for >= 5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician, (2) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, (3) adequately treated carcinoma in situ without evidence of disease, or (4) Gleason 6 prostate cancer under observationXx_NEWLINE_xXIndividuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: noninvasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of other malignancies, except:\r\n* Malignancy treated with curative intent and with no known active disease present before the first dose of study drug and felt to be at low risk for recurrence by treating physician\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease\r\n* Low-risk prostate cancer on active surveillanceXx_NEWLINE_xXSubject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed.Xx_NEWLINE_xXPrior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer or any other form of cancer from which the patient has been disease-free for 5 yearsXx_NEWLINE_xXPatients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanomaXx_NEWLINE_xXHistory of other malignancy(ies), except adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ? 3 years.Xx_NEWLINE_xXCuratively treated basal cell or squamous cell skin cancerXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease free for at least 3 years.Xx_NEWLINE_xXAny concurrent or previous malignancy within 5 years prior to enrollment except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer or carcinomas in situ) is eligible provided that she has been disease free for more than 5 years.Xx_NEWLINE_xXAny cancer that was curatively treated at least 3 years before entry into this studyXx_NEWLINE_xXHistory of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of diseaseXx_NEWLINE_xX