Any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, or other malignancies curatively treated >  years prior to study entry); patients with adenocarcinoma of the prostate that has been surgically treated and with a post-treatment prostate specific antigen (PSA) that is non-detectable will not be excluded
Patients with another active malignancy will not be eligible except for:\r\n* Resected basal cell carcinoma and squamous cell carcinoma of the skin, cervical or prostatic intraepithelial neoplasia, and ductal or lobular carcinoma in situ of the breast\r\n* Patients with localized prostate cancer who have received curative intent therapy are also eligible provided:\r\n** Surgically treated patients have an undetectable prostate specific antigen (PSA)\r\n** Patients treated with brachytherapy have a PSA within the institutional normal range\r\n** Patients who have received pelvic external beam radiotherapy are not eligible
Curatively treated cervical intraepithelial neoplasia or prostate carcinoma with current prostate specific antigen < . ng/mL; or
Other malignancy, unless the patient has been disease-free for at least  years following the completion of curative intent therapy, with the following exceptions:\r\n* Treated non-melanoma skin cancer, any in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\r\n* 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 radical prostatectomy or definitive prostate irradiation has been performed
Concomitant malignancies or previous malignancies with less than  years of disease-free interval at the time of enrollment (except non-melanoma skin cancer, cervical cancer in situ, prostate cancer with undetectable prostate specific antigen [PSA]); other concurrent malignancies must be discussed with the medical monitor prior to enrollment
Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years; patients with prostate cancer are allowed if prostate specific antigen (PSA) is less than 
Other malignancy within the last  years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least three years; patients with prostate cancer are allowed if prostate-specific antigen (PSA) is less than ; patients with indolent malignancies under control and which, in the opinion of the treating investigator, are unlikely to be clinically relevant or affect survival during the course of the study treatment and follow-up
Patients with another primary malignancy within  years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, clinically localized prostate cancer, biochemically relapsed non-metastatic prostate cancer (i.e. prostate specific antigen [PSA] only disease), or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
History of second malignancy within  years prior to study day  (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, stage I differentiated thyroid cancer that is resected or observed, or pTa /pTb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection, or cTa/cTb prostate cancer treated with brachytherapy or external beam radiation therapy with normal PSA since radiation)
Subject has a previous (within  years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade <  and prostate-specific antigen within normal range.
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  years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over  years before day  of protocol therapy and patients whose prostate-specific antigen (PSA) is undetectable at study entry
Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, or nonmelanomatous skin cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within  months, localized prostate cancer and prostate specific antigen (PSA) < . mg/dL on  consecutive measurements at least  months apart with the most recent one being within  weeks of study entry
Active second malignancy, i.e. patient known to have potentially fatal hematologic malignancy or another solid primary tumor present for which he/she may be (but not necessarily) currently receiving treatment; patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided treatment was completed >  years prior; patients with early-stage skin cancers and prostate cancer under surveillance with non-rising prostate specific antigen (PSA) are eligible
Patients with a currently active second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; patients are not considered to have a currently active malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >  years, and are considered by their physician to be at less than\r\n% risk of relapse; in addition, patients with basal cell carcinoma of the skin, superficial carcinoma of the bladder, carcinoma of the prostate with a current PSA value of < . ng/mL, or cervical intraepithelial neoplasia will be eligible; finally, patients who are on hormonal therapy for a history of either prostate cancer or breast cancer may enroll, if there has been no evidence of disease progression during the previous three years
Other active malignancy =<  years prior to registration; EXCEPTIONS: treated non-melanoma skin cancer, carcinoma-in-situ of the cervix, treated stage -, Gleason  or less, prostate cancer with a stable or undetectable prostate specific antigen (PSA) level, treated stage  breast cancer which is controlled and for which the patient received no thoracic radiation therapy (RT)
Presently has a second malignancy other than squamous cell carcinoma of the head and neck (SCCHN), or history of treatment for invasive cancer other than SCCHN in the past  years. Exceptions are:\r\n* Previously treated in-situ carcinoma (ie, noninvasive)\r\n* Cervical carcinoma stage B or less\r\n* Noninvasive basal cell and squamous cell skin carcinoma\r\n* Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
Prior malignancies within the past  year with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade  or less with stable prostate specific antigen (PSA) levels
Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least  years except for excised and cured: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T-, N, M resected differentiated thyroid carcinoma; superficial bladder cancer; Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection
History of second malignancy within  years prior to study day  (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, or Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen [PSA] since resection)
Diagnosis or treatment for any malignancy other than non-Hodgkin lymphoma (NHL) within the  years preceding day  of the protocol therapy; exceptions are:\r\n* Basal or squamous cell carcinoma of the skin\r\n* In situ malignancy that has been completely resected\r\n* Prostate cancer that was treated with prostatectomy or radiotherapy over  years before day  of protocol therapy as long as the prostate specific antigen (PSA) is undetectable
Has a known additional malignancy that has had progression or has required active treatments in the last three years; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; a history of prostate cancer that was treated with surgery is acceptable, provided that the following criteria are met: stage TNM or lower; prostate specific antigen (PSA) undetectable for  year while off androgen deprivation therapy; patients on active surveillance for low grade prostate cancer are allowed to participate
Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least  years following the completion of curative intent therapy, with the following exceptions:\r\n* Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\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
Subjects with a \currently active\ second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled; subjects are not considered to have a \currently active\ malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >  years, and are considered by their physician to be at less than % risk of relapse; in addition, subjects with basal or squamous cell carcinoma of the skin, superficial carcinoma of the bladder, carcinoma of the prostate with a current prostate-specific antigen (PSA) value of < . ng/mL, or cervical intraepithelial neoplasia will be eligible; finally, subjects who are on hormonal therapy for a history of either prostate cancer or breast cancer may enroll, provided that there has been no evidence of disease progression during the previous three years
Active malignancy within the last  years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, low-risk prostate cancer (i.e. prostate-specific antigen [PSA] =< , Gleason sum =< ), or carcinoma in situ of the cervix or breast
Any other cancer from which the patient has been disease-free for less than  years (except treated and cured basal-cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder and treated localized prostate cancer with undetectable prostate-specific antigen [PSA] for  years)
Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage TNM or lower; Gleason score ? and prostatic-specific antigen (PSA) undetectable for at least  year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation
Non-hematologic malignancy within the past  years aside from the following exceptions: \r\n* Adequately treated basal cell or squamous cell skin cancer \r\n* Carcinoma in situ of the cervix \r\n* Prostate cancer < Gleason grade  with a stable prostate specific antigen (PSA) \r\n* Successfully treated in situ carcinoma of the breast
Most recent prostate specific antigen (PSA) within  days of enrollment
History of other active malignancies <  years prior to screening except basal cell carcinoma, low grade Gleason score ?  prostate cancer that has been removed with undetectable prostate-specific antigen (PSA), and in situ cervical carcinoma.
Treatment for other carcinomas within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with stable prostate-specific antigen (PSA)
Any concurrent malignancy\r\n* Exceptions\r\n** Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\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
Any concurrent malignancy with the exception of the following: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) 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
Less than -years disease free from another primary malignancy (other than squamous or basal cell carcinoma of the skin, \in-situ\ carcinoma of the cervix or breast, superficial bladder carcinoma, or previously treated localized prostate cancer with normal prostate-specific antigen [PSA] levels); patients are not considered to have a \currently active\ malignancy if they have completed anti-cancer therapy, are considered by their physician to be at less than % risk of relapse and at least  years have lapsed
Patients with other known malignancies within the past three years except: i. adequately treated basal or squamous cell skin cancer; ii. carcinoma in situ of the cervix; iii. prostate cancer with Gleason score <  with stable prostate-specific antigen (PSA) over the past three months; iv. breast cancer in situ with full surgical resection
History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with prostate specific antigen (PSA) level < upper limit of normal (ULN)
Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy
Subject has a prior history of other malignancies unless disease free for ?  years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score <  with stable prostate specific antigen (PSA) levels.
History of non-lymphoid malignancy except for the following:\r\n* Adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requirement only hormonal therapy and with normal prostate specific antigen for >  year prior to the start of pembrolizumab, or any other cancer that has been in complete remission without treatment for ?  years prior to enrollment
History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >=  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* Ta or Tb or Tc prostate carcinoma treated with radiation >=  year prior to study enrollment and prostate specific antigen (PSA) within normal limits (WNL) since treatment \r\n* Ta or b prostate carcinoma treated curatively >=  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
Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least  years except for excised and cured: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T-, N, M resected differentiated thyroid carcinoma; superficial bladder cancer; Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection
Subjects with a currently active second malignancy, other than non-melanoma skin cancer, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT with Gleason score =<  and postoperative prostate-specific antigen [PSA] < . ng/mL), or other adequately treated carcinoma-in-situ are ineligible; patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for >=  year
History of prior malignancy, with the exception of the following:\r\n* Non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix\r\n* Prostate cancer not under active systemic treatment other than hormonal therapy and with documented undetectable prostate-specific antigen (PSA) (< . ng/mL)\r\n* Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) provided patient has isolated lymphocytosis (Rai stage O), and does not require systemic treatment (for B symptoms, Richters transformation, lymphocyte doubling time [<  months], lymphadenopathy or hepatosplenomegaly)\r\n* Lymphoma of any type of hairy-cell leukemia provided patient is not on active systemic treatment and is in complete remission, as evidenced by PET/CT scans and bone marrow biopsies for at least  months\r\n* History of malignancy provided that patient has completed therapy and is free of disease for >=  years; if patient had other malignancy within the last  years from which he may have been completely cured by surgery alone, he may be considered to be enrolled on condition that the risk of development of distant metastatic disease based on American Joint Committee on Cancer (AJCC) staging system is less than %
Patients with other malignancy within the last  years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma
Prior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or prostate cancer detectable only by prostate specific antigen [PSA]) unless disease free for over one year
Non-hematologic malignancy within the past  years aside from the following exceptions:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Carcinoma in situ of the cervix \r\n* Prostate cancer < Gleason grade  with a stable prostate-specific antigen test (PSA)\r\n* Successfully treated in situ carcinoma of the breast
Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least  years except for excised and cured: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T-, N, M resected differentiated thyroid carcinoma; superficial bladder cancer; Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection
History of second malignancy within  years prior to study day  (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, or Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen [PSA] since resection)
History of prior malignancy within the past  years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < . mg/dL on  successive evaluations, at least  months apart, with the most recent evaluation no more than  weeks prior to entry
History of prior malignancy within the past  years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of < . mg/dL on  successive evaluations, at least  months apart, with the most recent evaluation no more than  weeks prior to entry
History of another malignancy within  years, except cured basal cell carcinoma of the skin, treated ductal carcinoma in situ (DCIS), cured early stage prostate cancer without detectable prostate-specific antigen (PSA) or excised carcinoma in situ of the cervix
Participants with previous history of another malignant condition are excluded, except for localized cancers that have been adequately treated; this includes completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy (e.g. ductal carcinoma in situ [DCIS] of the breast), good risk prostate cancer after curative therapy and/or considered appropriate for watchful waiting (e.g. Gleason  or less, T or less and prostate-specific antigen [PSA] < ) , and stage I cervical cancer; if invasive malignancy was experienced  or more years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion and approval
History of other carcinomas within the last  years except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with a current Prostate-specific antigen (PSA) of <. mg/dL on  evaluations at least  months apart; the most recent evaluation must be no more than  weeks prior to Day  of the study drug, or other malignancies that were completely resected or treated Stage / lesions currently in complete remission.
Another primary malignancy that has not been in remission for at least  years; non-melanoma skin cancer, intraepithelial carcinoma of the cervix, or prostate cancer with a current prostate specific antigen (PSA) =< . ng/mL is allowed
Subjects with a history of another primary malignancy =<  years ago, with the exception of inactive basal, squamous cell carcinoma of the skin or superficial melanoma only requiring excision, prostate cancer with a prostate specific antigen (PSA) that has not increased for at least  months, carcinoma in situ of the cervix
Subject has a previous (within  years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade <  and prostate-specific antigen within normal range. Modifications to Eligibility Criteria for the following specific tumor types: Phase A will be limited to enrolling the following tumor types:
Have active malignancy within  years of entry. Active malignancy is defined as those malignancies requiring treatment with anti-cancer therapy or in the event of indolent malignancies, having measurable disease. Exceptions to this exclusion include: myelodysplastic syndrome, treated non-melanoma skin cancer, completely resected Stage  or  melanoma no less than  year from resection, carcinoma in situ or cervical intraepithelial neoplasia, and successfully treated organ-confined prostate cancer with no evidence of progressive disease based on prostate specific antigen (PSA) levels and are not on active therapy
Prior malignancies within the past  years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade  or less with stable prostate-specific antigen (PSA) levels
Active cancer (either concurrent or within the last year of starting study treatment) that requires therapy (eg, surgical, chemotherapy, or radiation therapy), with the exception of adequately treated basal or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix or breast, or prostate carcinoma with a prostate-specific antigen value <. ng/mL.
History of second malignancy within  years prior to study day  (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, resected stage I differentiated thyroid cancer, or Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection)
Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cancer; or prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer that is Stage TNM or lower, Gleason score<= , or prostatic-specific antigen (PSA) undetectable
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
Malignancy within  years before day , other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in-situ of the cervix and prostate carcinoma ? Gleason Grade  with stable prostate specific antigen (PSA) levels
Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of the cervix, incidental prostate cancer (Ta, Gleason less than or equal to , prostate specific antigen (PSA) less than . ng/ml) or any other tumour having received adequate treatment and evidencing a disease-free period greater than or equal to  years
Other malignancy, unless the patient has been disease-free for at least  years following the completion of curative intent therapy, with the following exceptions: treated non-melanoma skin cancer, any in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; 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 radical prostatectomy or definitive prostate irradiation has been performed
History of another malignancy <  years prior to starting study treatment or any malignancy with confirmed activating RAS-mutation; Exceptions: Subjects with any of the following malignancies within  years (does not include malignancies with confirmed activating RAS-mutation) are eligible: (a) a history of completely resected skin cancer, (b) successfully treated in situ carcinoma, (c) chronic lymphocytic lymphoma (CLL) in stable remission, or (d) indolent prostate cancer (definition: clinical stage T or Ta, Gleason score <= , and prostate specific antigen [PSA] <  ng/mL) requiring no or only anti-hormonal therapy with histologically confirmed tumour lesions that can be clearly differentiated from lung cancer target and non-target lesions are eligible
History of other malignancy <  years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only, limited stage prostate cancer treated with surgery or radiation therapy with currently undetectable prostate-specific antigen (PSA), or carcinoma in situ of the cervix
EXPANSION COHORT ONLY: History of another malignancy within  years, except the following: cured basal/squamous cell carcinoma of the skin, excised carcinoma in situ of the cervix; a history of prostate cancer that was identified incidentally following cystoprostatectomy or cystectomy for bladder cancer is acceptable provided that that following criteria are met: \r\n* Stage TNM or lower \r\n* Gleason score =<  \r\n* Negative margins at surgery, and \r\n* PSA undetectable after surgery
Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past  months. Subjects with history of localized & low risk prostate cancer are allowed in the study if they were treated with curative intent and there is no prostate specific antigen (PSA) recurrence within the past  years
No other malignancy except for non-melanomatous skin cancer, early stage prostate cancer (T < a and prostate specific antigen [PSA] <  and glucosinolates [GLS] < ) or a carcinoma not of head and neck origin disease free for >  yrs
Past or current malignancy other than SCCHN, except for:\r\n* Cervical carcinoma stage B or less\r\n* Non-invasive basal cell and squamous cell skin carcinoma\r\n* Malignant melanoma with a complete response of a duration of >  years \r\n* Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate specific antigen (PSA), and not requiring ongoing anti-androgen hormonal therapy\r\n* Other cancer diagnosis with a complete response of duration of >  years
History of incurable malignancy other than NSCLC within the  years prior to start of treatment, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value < . ng/mL; or basal or squamous-cell carcinoma of the skin
Presence of another primary malignancy within the past  years (except for non-melanoma skin cancer or cervical cancer in situ; prior prostate cancer is also permitted if prostate specific antigen [PSA] is now undetectable)
Had a second malignancy within the previous  years, except for basal cell carcinoma, cervical intra-epithelial neoplasia or treated prostate cancer with a prostate-specific antigen (PSA) of <. ng/mL;
Prior malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade  or less with stable prostate-specific antigen (PSA) levels (gonadotropin-releasing hormone [GnRH] analogs or androgen receptor blockers acceptable); or other cancers from which the subject has been disease-free for at least five years
History of any other prior lymphoid malignancy other than the registrational histology or any other non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ?  year prior to the start of study drug, or any other cancer that has been in complete remission without treatment for ?  years prior to enrollment
Curatively treated cervical intraepithelial neoplasia or prostate carcinoma with current prostate specific antigen (PSA) < . ng/mL; or
Second malignancy within past three years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, prostate cancer < Gleason score  with stable prostate-specific antigen (PSA) over the past three months, breast cancer in situ with full surgical resection, treated medullary or papillary thyroid cancer
Presence of other active malignancy with the exception of non-melanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits, or any completely resected carcinoma in situ
Patient has a history of other malignancies unless has undergone definitive treatment more than  yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <. ng/mL; or cervical intraepithelial neoplasia).
Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable prostate specific antigen [PSA]) for which the patient has not been disease free for at least  years
Have had a diagnosis of another malignancy, unless the participant has been disease-free for at least  years following the completion of curative intent therapy with the following exceptions:\r\n* Participants with treated non-melanoma skin cancer, in situ, carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed\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
Diagnosis or treatment for any malignancy other than non-Hodgkin lymphoma (NHL) within the  years preceding day  of the protocol therapy; exceptions are:\r\n* Basal or squamous cell carcinoma of the skin\r\n* In situ malignancy that has been completely resected\r\n* Prostate cancer that was treated with prostatectomy or radiotherapy over  years before day  of protocol therapy and whose prostate-specific antigen (PSA) is undetectable\r\n* In situ malignancy that was completely resected
Patient has a history of another malignancy within  years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T-, N, M differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; Ta or Tb prostate cancer comprising < % of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation
Detectable prostate-specific antigen (PSA)
History of prior malignancy, with the exception of the following:\r\n* Non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix \r\n* Prior history of prostate provided patient not under active systemic treatment other than hormonal therapy and with documented undetectable prostate-specific antigen (PSA) (< . ng/mL)\r\n* Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) provided patient has isolated lymphocytosis (Rai stage ), and does not require systemic treatment (for B symptoms, Richters transformation, lymphocyte doubling time [<  months], lymphadenopathy or hepatosplenomegaly)\r\n* Lymphoma or any type or hairy-cell leukemia provided patient is not on active systemic treatment and is in complete remission, as evidenced by PET/CT scans and bone marrow biopsies for at least  months\r\n* Papillary thyroid cancer; patients with concurrent metastatic melanoma can be enrolled; patients can be enrolled regardless of if they meet any of the following: A) have completed a thyroidectomy within the last  years, B) have or have not received adjuvant radioactive iodine therapy, or C) were only recently diagnosed with asymptomatic papillary thyroid cancer and their surgery is pending\r\n* History of malignancy provided patient has completed therapy and is free of disease for >=  years; if patient had other malignancy within the last  years from which he may have been completely cured by surgery alone, he may considered to be enrolled on condition that the risk of development of distant metastatic disease based on AJCC staging system is less than %
Prostate specific antigen (PSA) measurement =<  days prior to study enrollment