Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within  days prior to sub-study registration; patients must have recovered (=< grade ) from any side effects of prior therapy; patients must not have received any radiation therapy within  days prior to sub-study registration
>=  prior systemic therapy for sarcoma, including adjuvant systemic therapy
Patients must have had no prior systemic therapy
Have progressed on prior systemic therapy
Systemic chemotherapy/radiotherapy/investigational therapy within  days (with the exception of hydroxyurea and/or dexamethasone, or one dose of cytarabine) prior to starting therapy
Phase b only: Advanced solid malignancy with an emphasis on colorectal, head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
More than two prior systemic treatments for MDS. Prior systemic therapies are those that have been received at standard doses for at least one full treatment cycle.
No prior systemic treatment is allowed, except for subjects in the phase I cohort who are permitted one prior systemic treatment
Inclusion Criteria (Part  Only):\n\n          -  Histological or cytological diagnosis of locally advanced or metastatic NSCLC or\n             urothelial carcinoma who have progressed on or were intolerant to standard of care\n             systemic therapy, or for whom standard of care systemic therapy was refused (refusal\n             must be documented) or unavailable.\n\n          -  No prior treatment with anti-PD- or anti-PD-L therapy.\n\n          -  NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have\n             progressed on or after no more than  prior line of platinum-containing systemic\n             therapy or were intolerant or refused standard of care systemic therapy.\n\n          -  NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received\n             prior systemic therapies that only include  or more lines of ALK or EGFR targeting\n             drugs and chemotherapy limited to  line of a platinum-based regimen and they must\n             have progressed on or after both types of therapies.\n\n          -  Urothelial carcinoma patients must have received up to  lines of prior systemic\n             therapy and progressed on or after, experienced disease recurrence within  months of\n             neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused\n             platinum-containing systemic therapy.\n\n          -  Provide archived tumor tissue sample taken within the past  years or provide a fresh\n             tumor biopsy sample.\n\n          -  At least one measurable lesion as defined by RECIST version ..\n\n          -  Adequate renal, liver, thyroid and bone marrow function.\n\n          -  Performance status  or .\n\n          -  Patient is capable of receiving study treatment for at least  weeks.\n\n        Exclusion Criteria (Part  Only)\n\n          -  Active brain or leptomeningeal metastases.\n\n          -  Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes\n             mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone\n             replacement, psoriasis not requiring systemic treatment, or conditions not expected to\n             recur in the absence of an external trigger are permitted to enroll. Diagnosis of\n             prior immunodeficiency or organ transplant requiring immunosuppressive therapy or\n             prior allogeneic bone marrow or hematopoietic stem cell transplant.\n\n          -  Patients with a condition requiring systemic treatment with either corticosteroids\n             (>mg daily prednisone equivalents) or other immunosuppressive medications within \n             days of study drug administration. Inhaled or topical steroids, and adrenal\n             replacement doses > mg daily prednisone equivalents are permitted in the absence of\n             active autoimmune disease.\n\n          -  Patients with a history of interstitial lung disease, non-infectious pneumonitis, or\n             active pulmonary tuberculosis. Those with active lung infections requiring treatment\n             are also excluded.\n\n          -  History of Grade ? immune mediated AE (including AST/ALT elevations that where\n             considered drug related and cytokine release syndrome) that was considered related to\n             prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory\n             agents, etc.) and required immunosuppressive therapy.\n\n          -  Active hepatitis B or C, HIV/AIDS.\n\n          -  Other potentially metastatic malignancy within past  years.
Relapsed or are refractory to at least  prior systemic cytotoxic therapy. -Subjects must have received conventional therapy as a prior therapy.
Prior systemic therapy for incurable disease
Patients must not have received prior systemic therapy for PTCL (except for corticosteroids for  or fewer days at any dose, no washout period required as long as they discontinue prior to starting study therapy); NOTE: topical treatment may have been given for prior existence of cutaneous lymphoma that has since become systemic PTCL; however, these topical therapies should be stopped at time of registration
Prior systemic therapy:\r\n* Participants must have discontinued systemic therapy at least  days prior to initiating protocol therapy.\r\n* There is no limit to the number of prior lines of systemic therapy. Participants who have not received any systemic therapy for metastatic disease are also eligible.\r\n* Participants may initiate or continue bisphosphonate therapy on study
Patients must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma if standard treatment is appropriate. Treatment naive patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed more than  months previously.
Received any previously systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways; other previous targeted therapies are permitted if stopped at least  days prior to start of treatment
A) Patients enrolled into the dedifferentiated liposarcoma cohort do not require prior systemic therapy (may be naive to systemic therapy); B) leiomyosarcoma patients must have had at least  prior systemic therapy (does not include adjuvant/neoadjuvant therapy in a curative setting). There are no limits on prior number of therapies for either cohort
Patients must have been treated with at least one prior systemic regimen for sarcoma; adjuvant systemic therapy qualifies as prior therapy for the purposes of this study; there is no upper limit on previous lines of therapy received; a prior line of systemic therapy may include prior investigational agents received as part of other clinical studies
Must have received at least one prior systemic therapy
Prior therapy with any systemic therapy (chemotherapy or biologic therapy) within twenty-eight days prior to study entry
Prior systemic therapy
Prior malignancies requiring systemic therapy within the last  years (as prior therapy can increase toxicity of current chemo regimen, those patients should be excluded).
Patients may have received prior systemic and/or radiation therapy. All adverse events associated with prior systemic therapy or radiation therapy must have resolved to =< grade  prior to start of study
Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting, and including a platinum containing regimen)
Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone continued for treatment of adrenal insufficiency is not considered a systemic IST
No prior systemic therapy for lymphoma
Subjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); any patient that refuses standard chemotherapy for the treatment of their disease is also considered eligible; prior adjuvant therapy will not count provided it was completed more than  months previously
Prior systemic therapy for current diagnosis of HNSCC
Patients must have received <  cycles of systemic anti-myeloma therapy.
Malignancy requiring systemic therapy; Note: Kaposi sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy
Systemic therapy is allowed but SBRT cannot begin until >=  days after the last cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated until >=  days after SBRT; there will be no limit on prior lines of systemic therapy
Prior systemic cytotoxic therapy, antineoplastic biologic therapy, or major surgery within  days of first dose of study medication
Subjects must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) for their sarcoma; an exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., chondrosarcoma); prior adjuvant therapy will not count provided it was completed more than  months previously
At least  days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose is not allowed within  days prior to the required leukapheresis\r\n* NOTE:  days must elapse from the time of administration of anti-PD- or anti-PD-L antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cells
At least one prior systemic treatment (including neoadjuvant therapy) for their tumor of the small intestine, with intolerance to prior therapy, failure of the most recent therapy (of any line) or recurrent disease
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Systemic anticancer therapy within  days of the first dose of study drug\r\n* All adverse events from prior systemic therapy must have either stabilized or returned to baseline
Patients may have received prior systemic and/or radiation therapy; all adverse events associated with prior systemic therapy or radiation therapy must have resolved to =< grade  prior to start of study
The subject has a prior history of unrelated neoplastic disease, and has received systemic therapy for the secondary malignancy within the twelve () month period preceding the screening evaluation
At least  days must have elapsed since any prior systemic therapy prior to apheresis and prior to the initiation of chemotherapy (including systemic corticosteroids at any dose); systemic anti-malignancy therapy including systemic corticosteroid therapy of any dose are not allowed within  days prior to the required leukapheresis; NOTE:  days must elapse from the time of administration of anti-PD- or anti-PD-L antibodies or other agents that in the opinion of the principal investigator (PI) can stimulate immune activity and infusion of CAR T cells
Patients who have had chemotherapy, immunotherapy or any targeted therapy within  days prior to anticipated SRS treatment date or those planning for systemic therapy within  days following the protocol treatment
Patients must require systemic treatment
Patients can have received up to  lines of systemic treatment; psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
May have received at least  prior therapy for recurrent or metastatic disease, up to  prior systemic therapies.
Completion of prior systemic therapy at least  days prior to enrollment
Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy
Systemic anti-lymphoma therapy given in the previous  days before the scheduled Y therapy dose
Use of systemic chemotherapy and/or radiation therapy =<  days prior to first registration; palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics
Prior treatment of B-NHL with radiation therapy, non-standard systemic therapy, or antibiotics (in cases of MZL) within  days of the first dose of ixazomib
Prior systemic therapy
Any significant systemic infection within  weeks prior to dosing
Patients may be previously untreated or have received up to  prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use in the adjuvant or metastatic disease settings is permitted (in this trial interferon is mainly used to enhance or initiate immune responses to MK-); vaccine therapy will not be counted as systemic therapy; all prior therapies must have been discontinued for at least  weeks; a  week washout for kinase inhibitors is acceptable
Prior therapy for melanoma that may include surgery, radiation therapy, immunotherapy including interleukins and interferon, and/or ? different regiments of systemic chemotherapy, targeted therapy, or other experimental systemic therapies. Prior treatment with immune checkpoint inhibitors is not allowed.
In the phase II portion of the study, patients that have been previously treated with any systemic therapy for GIST are not permitted to enroll, with the exception of adjuvant imatinib systemic therapy or exposure to imatinib within  weeks of signing consent
Patients must have discontinued all previous systemic therapies and recovered from side effects due to systemic treatment for more than  days prior to starting on treatment
Systemic immunoglobulin therapy within the last  days
Patients with cerebral or systemic vasculopathy:
Phase II IMT naive cohorts: Patients have not received systemic cytotoxic or immune-based therapy for advanced melanoma. BRAF and/or MEK inhibition therapy is acceptable before immunotherapy where clinically indicated. Other systemic cytotoxic or targeted therapy in the advanced setting is not permitted in this subset
Many patients present with concomitant systemic disease outside of the central nervous system; extra-central nervous system (CNS) disease status should meet the following criteria:\r\n* Patients with concomitant systemic disease under control with current or prior systemic treatment, as per primary treating physician\r\n* Patients without any evidence of systemic disease, either receiving systemic treatment or on active observation (Cohort D)
Candidate for further therapy and able to wait  days prior to start of next systemic therapy
Patients must have discontinued systemic antineoplastic therapy (including endocrine and biological agents, as well as systemic corticosteroids) at least three () to four () weeks prior to enrollment. Toxicities from previous therapies must be grade  or less.
Patients must be refractory or intolerant to at least  prior standard systemic therapy, if a candidate for systemic therapy
Treatment with systemic cancer therapy within  days before screening.
Systemic anti-myeloma therapy (including systemic steroids) within  days, or plasmapheresis within  days prior to the first dose of study drug.
History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment
Patients who have received at least two cycles of initial systemic therapy and are within  to  months of the first dose. Mobilization therapy is not considered initial therapy.
Prior radiation or systemic therapy for the diagnosis of liposarcoma
Prior systemic treatment
Patients must have never received any prior systemic therapy for their disease.
Patient has had any systemic therapy within  weeks prior to initiating study drug.
Patients who received most recent therapy =<  weeks prior to registration; NOTE: use of systemic steroid therapy is allowed pretreatment
Patients must not have received chemotherapy within  days of enrollment, with the two following exceptions: \r\n* Routine systemic maintenance therapy (e.g., Abelson murine leukemia viral oncogene homolog  [ABL] kinase inhibitor, methotrexate, -mercaptopurine, vincristine, etc.) and intrathecal/intraventricular therapy\r\n* Systemic therapy for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Participant has received more than one prior systemic therapy regimen for SCLC.
Patients must have received at least one prior systemic therapy for lymphoma; a washout period of at least  weeks is required from the most recent prior therapy
Has had prior systemic therapy (exception: GnRH agonist or antagonist) or radiation therapy for prostate cancer within  weeks prior to study day ; there must be at least a  week washout period from last dose of any prior systemic or radiation therapy for prostate cancer prior to day  of study treatment (including nonsteroidal antiandrogens); screening may commence during this washout window
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within  days prior to Step  re-registration; patients must have recovered (=< grade ) from any side effects of prior therapy
Systemic therapy with sorafenib or other systemic chemotherapeutic agent(s) less than  week prior to first planned DEB-TACE
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within  days prior to re-registration; patients must have recovered (=< grade ) from any side effects of prior therapy
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within  days prior to step  re-registration; patients must have recovered (< grade ) from any side effects of prior therapy
Patient may have had any prior topical or systemic therapy except for total electron beam irradiation; patients must be a minimum of  weeks from topical therapy and  weeks from systemic therapies, phototherapy, or local radiation therapy before initiating protocol specific therapy except for HDACI if they are in Arm B; patients are allowed to take weak potency topical corticosteroids if patient has been on a stable dose for more than a month
Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for their unresectable malignant pleural mesothelioma; prior systemic chemotherapy or biologic therapy is allowed as neoadjuvant or adjuvant treatment, disease has now recurred, and all systemic treatment was completed >  months prior registration; prior therapy must not have included cediranib
Prior resection permitted, no prior systemic, ablative or infusion therapy permitted
Patient has not received prior anti-angiogenic therapy, systemic targeted agents or systemic chemotherapy\r\n* Prior surgical resection, chemoembolization or other local therapy prior to transplant is permitted
No prior or concurrent systemic or radiation therapy for the treatment of myeloma
Prior systemic therapy requirements.
Stable systemic disease
Subject has received no prior systemic therapy
Must not have received systemic antineoplastic therapy, including radiotherapy within  days of study treatment, with the exception of hydroxyurea or -mercaptopurine for the purposes of cytoreduction
Must not have received any prior systemic therapy for their mRCC.
Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting)
Prior malignancy requiring systemic therapy or radiation therapy within  year of randomization
Prior systemic therapy within  days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
Subjects who have received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Subjects who have received local hepatic injection chemotherapy are eligible.
Who have received at least two cycles of initial systemic therapy and are within  to  months of the first dose; mobilization therapy is not considered initial therapy
Relapsed or are refractory following at least  prior systemic therapeutic attempts ( prior systemic attempt for PTCL). For CTCL, extracorporal photochemotherapy (ECP) will be considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
NSCLC that has progressed during or following  -  prior systemic therapies for unresectable locally advanced or metastatic disease (at least one docetaxel, gemcitabine, or platinum analogue based therapy), or are intolerant of or refused standard cancer therapy. For squamous cell carcinoma, or adenocarcinoma without known activating mutation: the prior systemic therapy is at least one platinum analogue. For adenocarcinoma with known activating driver mutation: the prior systemic therapy is at least TKI directed
No systemic therapy for RRP for four weeks prior to treatment
Prior systemic therapy for WM
Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
Have received previous systemic therapy with ramucirumab
Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted therapies), and at least one regimen must have been platinum-based; immunotherapy will not be counted as a prior regimen; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least  weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) >=  days ( days for nitrosoureas or mitomycin C) prior to registration and have recovered (i.e., =< grade  or at baseline) from adverse events due to agents administered
No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >  months prior if given as part of multimodal treatment for locally advanced disease)
Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded; patient should have complete resolution of their systemic disease not requiring additional systemic therapy (e.g. maintenance rituximab or Decadron)
Patients may have received prior systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens); all adverse events associated with prior treatment must have resolved to =< grade  prior to registration
Patients may be on other systemic chemotherapies if progressive CNS disease occurs while on these treatments; NOTE: new systemic chemotherapies should not be started unless required to treat systemic disease and should not start until at least  follow up imaging study has been performed
Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
Systemic immune suppression or systemic therapy for cGvHD started within preceding  weeks including extracorporeal photopheresis
Participants with pcALCL who have received prior radiation therapy or at least  prior systemic therapy; participants with MF who have received at least  prior systemic therapy
Patients who have received any systemic corticosteroid therapy within  weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent
Prior systemic therapy within  days of study enrollment
Prior systemic therapy within  days of initiating protocol treatment
No prior systemic therapy; prior adjuvant therapy with interferon does not count
Baseline studies must be performed  weeks prior to the start of systemic therapy, and must document the extent of disease in the breast; the specifics of this are at physician discretion, but must address clinical signs and symptoms; if pre-therapy scans were not performed, scans performed within the first  weeks of systemic therapy, but prior to registration, will be accepted; radiology reports documenting status of disease must be available
Patients must have completed at least  weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patients age and menopausal status)\r\n* NOTE: The patient will be considered eligible if the last day of the treatment cycle meets the  weeks criteria\r\n* If systemic therapy is discontinued for toxicity, there is no distant progression and at least  weeks of therapy have been delivered, then the patient remains eligible; if systemic therapy is changed for reasons other than progression of disease (e.g. from chemotherapy to endocrine therapy), the patient remains eligible
Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or was not able to tolerate prior systemic therapy.
Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC. Patients who have received prior therapy must have had disease progression within  months of the last dose of previous systemic therapy
Has received prior systemic therapy for the treatment of SCLC
Received last dose of systemic cytotoxic therapy, radiation therapy or therapy with any investigational product within  days of enrollment.
Previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan; (if the patient received less than  -  months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy; otherwise systemic therapy should be given first
Received > hours of systemic antibacterial therapy within  hours of initiation of inpatient IV study drug
No systemic antineoplastic therapy may have been received between the time of biopsy and the first administration of study treatment.
Subjects with a history of recent (within  days) systemic therapy for their underlying malignancy
Prior systemic infection with BCG
Prior local therapy within  weeks (for both phases I and II) or prior systemic therapy within  weeks of starting protocol treatment
Prior systemic therapy within  days of initiating protocol treatment
Treatment nave or has received only one systemic therapy apart from adjuvant therapy.
Prior therapy defined as  prior systemic therapy for advanced disease
History of prior systemic BCG infection
History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
The subject has received systemic antineoplastic therapy within  days of study treatment, (however, hydroxyurea or -mercaptopurine can be given for the purposes of cytoreduction up to one day prior to enrollment, with the exceptions noted above in the inclusion criteria)
Maximum one prior systemic therapy regimen.
There are no restrictions on systemic therapy at enrollment
Systemic sites of disease need to be stable on systemic therapy based on the most recent (within  weeks) staging scans
Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred)
For Part , subjects may have had any number of prior systemic anti-cancer treatments, but may not have received more than  schedules of myeloablative chemotherapy. For Parts  and , more than two prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma are not permitted. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least  weeks prior to Study Day  (Parts  and ) or randomization (Part .)
May be systemic nave or received up to two previous systemic treatment regimens for metastatic melanoma.
No prior systemic therapy, immunotherapy, investigational agent, chemoembolization, radioembolization or radiation therapy within the last  weeks.
Part D - Diagnosed with cholangiocarcinoma and have not received more than  prior systemic therapy
Patients must not have received any systemic corticosteroid therapy for  weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent
No systemic therapy within  weeks prior to registration or plan for systemic therapy within the first  weeks after study registration
Subject has participated in another clinical study for systemic therapy within  weeks of baseline.
Systemic immune suppression or systemic therapy for cGVHD started within preceding  weeks
Receiving systemic cancer therapy (including conventional chemotherapy, novel/targeted agents, immunotherapy, monoclonal antibody therapy, oral tyrosine kinase inhibitors, or hormonal agents) OR will begin systemic therapy within the next  weeks OR has received systemic therapy and reports that they are still experiencing side effects or complications of the cancer or cancer treatment
Hepatic locoregional therapy following prior systemic therapy or within  days prior to randomization.
Plan to initiate systemic cancer therapy within plus or minus (+-)  week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care
Any prior systemic therapy is permitted (except cisplatin or carboplatin)
Patients with small cell carcinoma must have progressed after at least one prior systemic therapy; patients with squamous cell carcinoma or adenocarcinoma may be previously untreated or have progressed after prior systemic therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; NOTE: There is no maximum number of prior treatments allowed
Plan to start a new systemic therapy for metastatic disease
Systemic radioisotope therapy within  weeks prior to study enrollment
Patients with metastatic disease may have received prior nephrectomy and/or prior systemic therapy (no limit on number); their baseline pMRI would be performed prior to starting a new treatment
Prior systemic cancer therapy
Received any systemic therapy within  days prior to planned B-WARM therapy\r\n* Patients may be enrolled on study but at least  days should elapse prior to date of B-WARM therapy
CRITERIA FOR SYSTEMIC THERAPY WITH ERLOTINIB