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)
Patients 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.
Patients 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.
Patients 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 applied
Patient 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 months
Patients 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 years
Patients 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 disease
History 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 enrollment
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
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 years
Curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy
Solid tumor treated curatively more than 5 years previously without evidence of recurrence
History of a second 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 malignancy with no known active disease present and no treatment administered during the last 2 years.
History 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 carcinoma
History of prior or current synchronous malignancy, except:\r\n* Malignancy that was treated with curative intent and for which there has been no known active disease for > 3 years prior to enrollment\r\n* Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, without evidence of prostate cancer
Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening.
Malignancies other than 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, non-melanoma skin carcinoma, or Stage I uterine cancer)
Curatively treated ductal carcinoma in situ of the breast.
Prior 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 years
Participants may not have been treated intratumorally with polyICLC.
Other prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the study, including response rate and safety
Patients 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 years
Prior 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 randomization
No history of prior or synchronous malignancy, except\r\n* Prior malignancy was treated with curative intent and there is no known active disease present for greater than or equal to 3 years prior to study entry\r\n* Participants with adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer are eligible
Primary disease site must be able to be treated with curative intent
ENROLLMENT 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 allowed
Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis
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, which is in remission, will be reviewed on a case-by-case basis by the Protocol Officer or one of the Protocol Chairs.
Patients 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.
History 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 years
Participant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin 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. Randomization Exclusion Criteria
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 disease
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 Chairs and/or Protocol Officer.
Malignancy treated with curative intent and with no known active disease present for ? 3 years before enrollment
Adequately treated non-melanoma skin cancer or lentigo maligna
Adequately treated cervical carcinoma in situ
Adequately treated breast ductal carcinoma in situ
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 disease
Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening
Second malignancy requiring concurrent treatment or those with non-hematological malignancies (except non-melanoma skin cancers); 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 is allowed
Malignancies 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)
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
Previous 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 years
Patients 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 years
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 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.
Malignancies other than UCa within 3 years prior to Day 0, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome;
History of another primary malignancy that has not been in remission for at least 1 year (the following are exempt from the 1-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, curatively treated superficial bladder cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear)
History 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 screening
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
Malignancy treated with curative intent and with no known active disease > 5 years prior to the start of CMP-001 dosing on W1D1 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 disease (e.g. cervical cancer in situ).
Previous malignant disease (other than the target malignancy to be investigated in this trial) within 3 years prior to study treatment initiation. Subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ, previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Principal investigator.
History 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 treated
History 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 disease
Previously treated in situ carcinoma (i.e., noninvasive)
Must 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 years
Has 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 years
History 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.
History 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.
Patients 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.
Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
History 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.
Previous or concurrent malignancy with exception of adequately treated basal cell or squamous cell carcinoma, in-situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and patients whose prostate-specific antigen (PSA) is undetectable at study entry
History 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)
Malignancies 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).
Malignancies 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 allowed
curatively treated non-melanomatous skin cancer
curatively treated cervical carcinoma in situ
History 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)
A 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).
Curatively treated in situ disease
History 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).
Malignancies 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)
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 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 disease
Malignancies 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.)
History 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 1/2
History 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 situ
Patients 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.
History of another primary malignancy except for: (i) OPSCC with loco-regional recurrence after 6 months of curative-intent treatment and amenable to salvage surgery; (ii) malignancy treated with curative intent and with no evidence of active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence; (iii) non-melanoma, skin cancer or lentigo maligna; in situ cervical, breast, prostate or bladder carcinoma
Malignancies 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)
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
Malignancies 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).
Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to registration
Patients with prior invasive malignancies are allowed, provided they have been treated with definitive intent and have no evidence of active disease requiring treatment in the past 2 years
History 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 randomization
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
Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanoma skin cancer or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for ? 5 years; other cases will be reviewed and possibly allowed if discussed with and approved by medical monitor
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 disease
Previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated non-melanoma skin carcinoma, noninvasive aerodigestive neoplasms or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments for concurrent cancers must be completed at least 3 years prior to registration
History 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.
Malignancies 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.)
Malignancies 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)
History 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)
Presence 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 resection
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
Malignancies 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.)
History 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 screening
History 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 situ
No 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 allowed
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
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 (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)
Previous 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 years
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 disease
Has a diagnosed additional malignancy within 3 years prior to first dose of study treatment with the exception of curatively treated in-situ cancer
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
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 malignancy without evidence of disease\r\n* Adequately treated carcinoma in situ or T1 urothelial cancer without evidence of disease
Prior diagnosis of non-hematologic malignancy within 5 years of planned protocol therapy EXCEPT:\r\n* Diagnosis of breast ductal carcinoma in situ treated with curative intent\r\n* Diagnosis of prostate adenocarcinoma with Gleasons score =< 6 treated with curative intent\r\n* Non-melanomatous skin cancer
Patients 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 disease
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 PI
Prior 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.
Patients with a history of active malignancy within 3 years prior to registration; note: exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease or prostate cancers with a Gleason score < 8 and with prostatectomy and no lymph node involvement
History of invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer)
History 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.
History 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 years
Diagnosed 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”
History 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
History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that has not been treated in the prior 3 months or expected to require treatment for recurrence during the course of the study
History of another primary malignancy within the last 3 years except: \r\n* Adequately treated in situ carcinoma of the cervix\r\n* Non-melanoma carcinoma of the skin\r\n* Any other curatively treated malignancy that has not been treated in the prior 3 months and is not expected to require treatment for recurrence during the course of the study
A history of other malignancy with the exception of those treated with curative intent with no evidence of disease for 2 years
Diagnosis 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)
History of prior malignancy with the exception of cervical intraepithelial neoplasia, non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <1.0). Patients with a history of other malignancies must have undergone potentially curative therapy and have no evidence of that disease for five years
Second 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 recurrence
History 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.
A history of other malignancy, unless treated with curative intent, and no evidence of disease for at least 2 years.
History of other malignancy within the past 3 years except treated with curative intent and no known active disease present and has not received chemotherapy for >= 1 year before enrollment/randomization and low risk for recurrence
Any concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy
Previous other malignancies unless they have undergone curative intent therapy for that malignancy and (1) have had no evidence of that disease for 5 years, and/or (2) be deemed at low risk for recurrence (less than or equal to 20% at 5 years)
Second primary malignancy except most situ carcinoma (e.g. in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence
Patients with prior malignancies are allowed, provided they have been treated with curative intent and have no evidence of active disease
curatively treated in-situ cancer, or
other malignancies curatively treated with no evidence of disease for ? 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
Other malignancy within 5 years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancer
Patients 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 participation
Malignancies 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 intent
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years
No prior malignancies within 5 years, unless treated early stage breast cancer, treated carcinoma in situ of the cervix, resected skin malignancies, or treated prostate cancer
Other 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.
Previously treated in-situ carcinoma (ie, noninvasive)
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 disease
any cancer curatively treated > 3 years before randomization
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)
History 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.
Second primary malignancy, except those second primary malignancies that are not considered to be competing causes of death in the opinion of the treating investigator; examples include: in situ carcinoma of the cervix, adequately treated non-melanoma carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence
Patients with a history of other malignancies during the past three years. (The following are exempt from the three-year limit: non-melanoma skin cancer, Lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ).
Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
Previous 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 years
History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ?5 years
213 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.
Active malignancies within 3 years except for those with a negligible risk of metastasis or death treated with expected curative outcome.
Other 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.
Other 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
Other 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)
Malignancies 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.)
History 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 situ
History 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 screening
Patients 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 treated
History 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.
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.
History 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 PI
Diagnosed 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 years
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; or \r\n* Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ
Malignancies 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 intent
Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed without evidence of recurrence
Malignancies 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.)
Presence 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.
Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
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 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 disease
Other active malignancy =< 3 years prior to registration; EXCEPTIONS: adequately treated non-melanotic skin cancer (adequate wound healing is required prior to study entry) or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior solid tumor malignancy, it must have been treated curatively with no evidence of recurrence =< 3 years prior to registration
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
Any concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence
History 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 screening
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
Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
Adequately treated carcinoma in situ without current evidence of disease
Malignancies 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.)
Patients 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 years
Second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remission
Patients with an active second primary cancer will not be eligible; patients curatively treated for a second cancer > 5 years prior to enrollment without a recurrence are eligible; patients curatively treated for a second primary cancer within the last 5 years with a =< 5% risk of recurrence are eligible; patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine cervix will be allowed on study
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study
Diagnosed 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 disease
Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer; for most diseases this time frame is 5 years
b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Prior 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.
Prior 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.
In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years, or indolent tumors for which observation over three years is a reasonable option
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
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 malignancy 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
Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Other active malignancies besides NSCLC within 3 years prior to Screening. Exceptions: adequately treated malignancies not likely to require therapy (e.g., completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma). Subjects must be in complete remission from prior malignancy in order to be eligible to enter the study.
Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; and c) other primary solid tumors (with no known active disease present) that, in the opinion of the investigator, will not affect patient outcome in the setting of the current diagnosis
Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current FLC diagnosis.
No 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 disease
History 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
Malignancies 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)
Any 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 disease
Malignancies other than NSCLC within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death
Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis.
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 disease
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Other malignancies within the past 3 years except for the following: adequately treated cervical or vulvar carcinoma in situ, treated basal cell or squamous carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), ductal carcinoma in situ (DCIS) of the breast and low grade prostate cancer; any cancer curatively treated > 3 years prior to entry with no clinical evidence of recurrence is permitted
No second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence.
No 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 response
Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
Malignancies 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:
Malignancies 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)
Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor.
History 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 observation
History 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 cancer
Has a history of prior cancers not included in this study that were either not treated with curative intent or have been active within the past 5 years
No 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 disease
Participant 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).
Any 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 disease
Malignancies 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.)
Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
Previous 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 years
Patients with history of previously treated malignancies who do not have any evidence of disease for the last three years are allowed
Subjects 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 disease
Malignancies other than urothelial bladder 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 or incidental prostate cancer
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
History of another active malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and superficial bladder cancer; participants treated for malignancy with no relapse within two years are eligible to participate in the study
Prior 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.
Other 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.
Other 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.
Malignancies 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.)
Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current diagnosis.
History 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
Diagnosed 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 disease
Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis
History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer
Patients with second primary cancer (except adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix or superficial bladder cancer, or other solid tumors including lymphoma without bone marrow involvement curatively treated with no evidence of disease for >= 5 years)
Evidence of another active cancer that may influence patient outcome as determined by the principal investigator (PI) or co-principal investigator (co-PI), except for non-melanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix curatively treated, treated superficial bladder cancer, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment prostate-specific antigen (PSA) that is non-detectable
History 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-situ
Previous 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 years
History 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-situ
History 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 disease
History 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 enrollment
Diagnosis of another malignancy, unless the patient was diagnosed at least 3 years earlier and has been disease-free for at least 6 months following the completion of curative intent therapy, specifics as follows:\r\n* Curatively resected non-melanomatous skin cancer \r\n* Curatively treated cervical carcinoma in situ\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
History of prior or synchronous malignancy except:\r\n* A malignancy that was treated with curative intent and for which there has been no known active disease for > 3 years prior to randomization\r\n* Curatively treated non-melanoma skin malignancy, cervical cancer in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer
History of other malignancies, except for other solid tumors curatively treated with no evidence of disease for > 3 years prior to enrollment
Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer.
History 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 years
The patient has history of another primary malignancy, with the exception of\r\n* Curatively treated non-melanomatous skin cancer;\r\n* Curatively treated cervical carcinoma in situ; \r\n* Non-metastatic prostate cancer\r\n* Other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to registration
Diagnosed 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 disease
Malignancies 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)
Malignancies 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.)
History 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 disease
History 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 cancer
History of any prior cancer curatively treated within the last two years except:\r\n* Any non-melanoma skin cancer\r\n* Any cancer excised, not treated with chemotherapy and with less than a 30% chance of recurrence within the next 2 years from registration
History of another primary cancer, except:\r\n* Curatively treated cervical carcinoma in situ, or\r\n* Curatively resected non-melanomatous skin cancer, or\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >= 3 years prior to enrollment
Diagnosed 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 disease
Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before screening
History 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.
Any 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 disease
Malignancies 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)
History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or breast are allowed. Patients with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in complete remission without treatment for at least 1 year prior to Cycle 1 Day 1 of study treatment. A recent history of myelodysplastic syndrome in patients with secondary leukemia is allowed
Malignancy treated with curative intent and with no known active disease present for ?3 years before the first dose of study drug and with low risk of recurrence by treating physician.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
Any other active malignancy. Any other previous malignancy is allowed providing that the tumor was curatively resected and there is no evidence of recurrence within 12 months prior to enrolment to the study. In addition, adequately treated in-situ carcinoma of the cervix, uteri, or non-melanonatous skin cancer are allowed provided that all treatment was completed 6 months prior to enrollment.
History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.
History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.
History 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 years
History 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
History of other malignancy up to 5 years prior to study entry 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, low grade, early stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent, are generally eligible.
History 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 enrollment
History 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 years
Malignancies 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 intent
Other cancer curatively treated with no evidence of disease for at least 5 years
Malignancies 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.)
Prior 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 investigator
Current requirement for anti-coagulation therapy that prolongs PT or aPTT 7. History of prior malignancy except: Curatively treated non-melanoma skin cancer; Solid tumor treated curatively >5 years previously without evidence of recurrence; or History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect (e.g., superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast);
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
History 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.
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.
Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
History 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 cancer
Second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence
History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanomatous skin carcinoma or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 3 years; other cases will be reviewed and possibly allowed if discussed with and approved by the principal investigator
Curatively treated ductal carcinoma in situ of the breast;
Malignancies 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 intent
History 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
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.
Malignancies 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 intent
Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
Curatively treated cervical carcinoma in situ.
History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease
Other 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.
History 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 years
Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis.
Second 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 recurrence
Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current cancer diagnosis.
Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that, in the opinion of the investigator, will not affect patient outcome in the setting of current hepatocellular carcinoma diagnosis.
History 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 disease
History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for >= 5 years
History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or patients who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
Has 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 years
The 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.
History of other malignancies except: \r\n* Adequately treated basal or squamous cell carcinoma of the skin\r\n* Curatively treated in situ carcinoma of the uterine cervix, prostate cancer, or superficial bladder cancer; OR\r\n* Other curatively treated solid tumor with no evidence of disease for >= 3 years
Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
History 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;
The 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 years
Second 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).
Prior 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 allowed
Patients 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 allowed
Malignancies 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 relapse
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)
Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
History of malignancy other than the underlying disease unless treated with a curative intent and/or no evidence of disease for at least 3 years (y) OR expected to be cured with SCT
Patients to be treated with RT for curative intent
Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to registration
Treated for any other cancer
Malignancies 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 Medications
History 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;
Subjects with history of another primary cancer, with the exception of: \r\n* Curatively resected non-melanoma skin cancer\r\n* Curatively treated cervical carcinoma in situ\r\n* Other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC
History 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 surgery
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 disease\r\n* Low-risk prostate cancer on active surveillance
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 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 situ
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Patients with prior malignancies are excluded unless treated with curative intent and known to be free of disease for at least 2 years
Patient must not have a history of other malignancy that has not been in remission for at least 3 years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treated
Any non-invasive malignancy not treated with curative intent or with knownactive disease within 5 years before randomization
History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
Patients 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.
EXCLUSION 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 disease
Patients 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 allowed
Malignancies 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)
No 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 years
History 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.
Patients 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
Patients 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.
A patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor; a cancer survivor is eligible provided that the following criteria are met: \r\n* The patient has undergone potentially curative therapy for all prior malignancies; \r\n* There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone); and \r\n* The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies
Curatively treated in situ disease
Malignancies 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)
Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization.
History 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 observation
History 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 surveillance
Subject 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.
Patients with known, active (i.e. not adequately treated with curative intent) malignancies other than melanoma
Malignancies within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
History 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.
Known other previous/current malignancy requiring treatment within ? 3 years except for liited disease treated with curative intent
Any cancer that was curatively treated at least 3 years before entry into this study
History 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 disease