Patients with hormone receptor positive breast cancer as defined above must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression; (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required); hormonal therapy can be initiated prior to or during protocol therapy
Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
Prior malignancy is allowed providing it does not require concurrent therapy\r\n* Exception: active hormonal therapy is allowed
hormonal therapy
one prior hormonal therapy and one prior chemotherapy regimen; or
Subject must not have had more than 24 months of hormonal therapy in combination with prostatectomy or radiation in the setting of localized disease and must not have shown any evidence of disease recurrence within 12 months after stopping hormonal therapy; disease recurrence after hormonal therapy is defined as PSA > 0.2 ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0 ng/dl more than the PSA nadir after radiotherapy + hormonal therapy; previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment
Patients who are actively receiving any other anticancer therapy except for hormonal therapy for well-controlled breast or prostate cancer
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and greater than 6 months before entry is acceptable)
Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), or any systemic corticosteroid, must discontinue the agent for at least four weeks prior to ipilimumab treatment; progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist)
Subjects on bisphosphonates/denosumab for any cancer or on hormone therapy for prostate cancer may continue this therapy; however, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy or refused or is intolerant of hormonal therapy
Hormonal therapy during the study or within 2 weeks of first study enrollment
Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil are not eligible
If patient has already started hormonal blockade therapy after radiation as adjuvant therapy, patient is eligible as long as the hormonal therapy was initiated no more than 6 months by the time of screening and can start the study drug within 4 weeks since the completion of screening.
Any hormonal therapy being taken as a treatment for cancer must be discontinued at least one week prior to registration; continuation of hormone replacement therapy e.g. thyroid hormone replacement therapy is permitted
Participant may have received prior hormonal therapy
Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for prostate cancer hormonal therapy, and treatment with MVT-5873 and MVT-2163.
Patients who concurrently use hormonal therapy and/or concurrent radiation therapy
No prior chemotherapy in the recurrent setting; prior hormonal therapy is permitted; concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment; low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given
Ongoing treatment with hormonal agents (e.g. finasteride, dutasteride, ketoconazole, hormonal birth control, estrogen replacement therapy, testosterone replacement therapy) or herbal products that may have hormonal activity (saw palmetto, black cohosh); patients taking these agents are eligible for screening, but must be willing to undergo a washout period of 4 weeks prior to starting study treatment
Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
No plan to treat with adjuvant hormonal or radiation therapy
Chemotherapy (including hormonal therapy) within the past 5 years from date of registration
Hormonal therapy within 2 weeks before the first dose of study treatment
Hormonal therapy within 1 week
Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment; patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study
Patients must be >= 4 weeks beyond treatment of any chemotherapy, other investigational therapy, hormonal, biological, targeted agents or radiotherapy, and must have recovered to =< grade 1 or previous baseline for each toxicity; exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field; patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 weeks (wks), whichever is shorter, from the last day of treatment; continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotropin-releasing hormone [GnRH] agonist), ovarian, or breast cancer are not exclusionary
Patients may have received prior hormonal therapy; the hormonal treatment must have been discontinued for > 6 months prior to study entry
Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
Concurrent hormonal therapy, except for bisphosphonates,during or within 30 days prior to start of study drug
Hormonal therapies acting on the hypothalamic-pituitary-gonadal axis (i.e., LHRH agonist/antagonist) are permitted. No other hormonal therapy is permitted;
Patients receiving any systemic chemotherapy, hormonal therapy or radiotherapy.
Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least 4 weeks prior to registration
Timing of prior therapy:\r\n* Prior hormonal therapy is allowed; hormonal therapy must be discontinued at least 7 days before initiation of protocol therapy\r\n* Ovarian suppression which has been used for > 6 months, during which time there has been disease progression, is allowed concurrently with protocol-based therapy; other hormonal agents (e.g. tamoxifen, aromatase inhibitors, fulvestrant) should be discontinued prior to study entry\r\n* If received, chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry\r\n* Patients must have completed radiation therapy at least 7 days prior to beginning protocol treatment\r\n* Patients must have sufficiently recovered from all reversible toxicities related to prior therapy before beginning protocol treatment, with the exception of alopecia
Participants may or may not be receiving hormonal therapy at the time of study entry
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. (these patients are eligible if this therapy is discontinued prior to randomization)
Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ? 36 months in duration and ? 9 months before randomization, or a single dose or a short course (? 6 months) of hormonal therapy given for rising PSA ? 9 months before randomization is allowed.;
Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure)
Any chemotherapy within 3 weeks of the first dose of AZD1775, except hormonal therapy in the refractory cohort.
Patients who have previously received hormonal therapy for endometrial cancer.
Patients may not receive any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) while on this study other than hydroxyurea for control of counts
Subjects who have been on hormonal therapy up to 30 days prior to enrollment and receiving degarelix are allowed to be on the study
In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg.
No limit in number of prior hormonal agents in metastatic breast cancer; only one prior chemotherapy is allowed in metastatic setting; anti-HER2 targeting therapy, CDK4/6 inhibitor, other targeted therapy (e.g., mTOR or PI3K inhibitor) in combination with hormonal treatment will be counted as one hormonal agent; any anti-HER2 targeting therapy in combination with chemotherapy will not be counted as one additional treatment
Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment
History of hormonal therapy for endometrial carcinoma for more than 3 months;
Prior hormonal therapy:\r\n* Patients may have had prior hormonal therapy with any hormonal agent with the exception of fulvestrant or anastrozole in the neo-adjuvant, adjuvant, or metastatic setting and with subsequent documented progression, or while on treatment with fulvestrant or anastrozole hormonal therapy and as long as other study eligibility criteria are met\r\n* If the patient had adjuvant therapy with anastrozole and developed metastatic disease more than 6 months after completion of anastrozole in adjuvant setting, she is eligible to participate as long other eligibility criteria are met\r\n* If anastrozole or fulvestrant were used in the past but discontinued due to intolerance and not due to progression of disease the patient is eligible to participate in this study as long this felt clinically safe and acceptable by the principal investigator and discussed with the patient who is in agreement\r\n* All other active treatments for breast cancer such as radiation therapy, hormonal therapy or other investigational therapies will have to be discontinued >= 21days before the therapy T+P on this protocol is started
Patients treated with hormonal therapy are eligible for the study
Endocrine therapy\r\n* May have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer; patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks
Patients who have received prior hormonal therapy are excluded from the trial, except for: patients who have received up to 6 months of hormonal therapy as neoadjuvant therapy before radical prostatectomy or while on radiation therapy, as long as more than 1 year has elapsed between discontinuation of the neoadjuvant hormonal therapy and initiation of hormonal treatment for relapsing disease
More than 8 months of prior hormonal therapy (e.g., gonadotropin-releasing hormone analogs, megestrol acetate, or Casodex)\r\n* Note: patients who have been on prior hormonal therapy must wait at least 1 year after the drug is fully metabolized to start treatment on protocol
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment; patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia
Treatment with another chemotherapy or hormonal therapy within the past 2 weeks
Subjects must have received prior hormonal therapy for the treatment of breast cancer as follows:\r\n* Progression must be documented while taking a nonsteroidal aromatase inhibitor including anastrozole or letrozole\r\n* If hormonal therapy was administered in the adjuvant setting, subjects must have received therapy for at least 6 months prior to developing metastatic disease\r\n* If hormonal therapy was administered in the metastatic setting, subjects must have received therapy for at least 3 months prior to progression
Prior non-hormonal therapy or radiation therapy for the current breast cancer; or hormonal therapy within 28 days prior to study entry; or refusal to discontinue hormonal therapy
Subject may have received prior hormonal therapy
Subjects may begin cediranib and olaparib at least 3 weeks after their last dose of chemotherapy or hormonal therapy, assuming they are otherwise eligible
Prior therapy for breast cancer, including irradiation, chemo-, immuno- and/or hormonal therapy
Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
If the subject has ER+ breast cancer, prior therapy must have included at least 1 hormonal therapy
Patients must have stable use of hormonal therapy for two weeks prior to cryoablation procedure)
Patients who have previously received enzalutamide; patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy
Treatment with biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
Washout from prior hormonal therapy of at least 2 weeks prior to C1D1
Patients who are taking any form of other exogenous hormonal therapy within 21 days prior to first dose of orteronel; examples of exogenous hormonal therapy include: vaginal estrogens, transdermal testosterone, etc; the principal investigator (PI) will have the final say regarding what constitutes an exogenous hormonal therapy
Prior malignancy is allowed providing it does not require concurrent therapy; exception: active hormonal therapy is allowed
Treatment with continuous or intermittent small molecular therapeutics, biologic therapy or hormonal therapy within 28 days prior to first dose of study treatment.
No prior hormonal therapy for treatment of cancer within the past 21 days
Patients may have a history of prior (non-colonic) malignancies, provided there is no current clinical evidence of persistent or recurrent disease and the patient is on no active therapy, including hormonal therapy
Has had prior hormonal therapy such as Lupron or oral anti-androgens
Hormonal therapy for prostate cancer within three months of procedure,
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and > 6 months before entry is acceptable)
Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy (Note: hormonal therapy is allowed)
In active cancer treatment or have completed active cancer treatment within 12 months of obtaining consent (with the exception of adjuvant hormonal therapy)
Prior therapy with hormonal progestin agents;
Hormonal therapy must have been discontinued =< 14 days prior to initiation of study therapy; however, continuation of ovarian suppression is allowed
Prior hormonal therapy is allowed (no washout period is required after hormonal therapy)
Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)
Patients who did not enroll during their chemotherapy are still eligible to enroll during subsequent hormonal therapy or radiation as long as it within 6 months of diagnosis
Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
Receiving hormonal treatment
Those prescribed a hormonal therapy for cancer
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Women over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms
Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date
Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention within the next year (Note: Individuals taking tamoxifen, Arimidex or other hormonal prevention strategies at time of consent will be eligible)
Concurrent use of hormonal contraception or hormone replacement therapy
Subjects who have received hormonal contraception and/or hormone therapy in the past 3 months are not eligible
Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
On adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
May or may not be on hormonal therapy, chemotherapy, or radium therapy; if on hormonal therapy or chemotherapy, must be on it for at least 3 months
Previous hormonal therapy is allowed
Are currently taking any hormonal therapy or have been on hormonal therapy in the past 4 weeks
Participants must have no immediate requirements for chemotherapy, radiotherapy or hormonal therapy
Completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
No concurrent treatment with other cytotoxic drugs or targeted therapies
Prior treatment with a BCMA-targeted agent
The most recent cytotoxic, biologic or non-hormonal targeted therapy received must have been completed at least 21 days prior to study treatment
Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted)
Any prior therapy targeted against PSMA
Prior or ongoing treatment with any of the following:\r\n* EGFR targeted therapy (TKI or antibody) or any other targeted therapies targeting the ERBB family\r\n* Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of advanced NSCLC
Prior or ongoing treatment with any of the following:\r\n* EGFR targeted therapy (TKI or antibody) or any other targeted therapies targeting the ERBB family\r\n* Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of metastatic NSCLC
Patients may continue therapy with a targeted agent if CNS disease developed while receiving the agent, and for defined regimens that have been deemed safe when combined with anti-PD-1 therapy
Previous treatment with any HER2-targeted therapy Erlotinib
Patients with solid tumors: Have received anticancer therapies, including radiation therapy, cytotoxic agents, targeted agents or endocrine therapy within 2 weeks prior to dose assignment
Having gotten prior PD1 therapy is allowed for, especially if they have previously progressed on it; progression may include extra-cranial as well as intra-cranial progression; after progressing on PD1 therapy, intervening chemotherapy and/or targeted therapy (BRAF inhibitors [BRAFi], etc) is allowed; if they are on intervening chemotherapy and/or targeted therapy (BRAFi, etc), they have to have progression intra-cranially and/or extra-cranially and must be off intervening therapy for at least 2 weeks
Prior radiation therapy (RT) after the initial diagnosis will be allowed; patients with prior RT must be at least 6 months from the completion of RT (or radiosurgery); prior chemotherapy or molecularly targeted therapy will be allowed; patients with prior chemotherapy must be at least 6 months from the last dose of chemotherapy or molecularly targeted therapy
Any number of prior chemotherapy or targeted agents including rapamycin analogues are allowed
Unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
Patients who have received targeted prior VEGFR or FGFR-targeted agents (i.e. sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, etc.)
treatment with molecular targeted agents within 2 weeks prior to treatment with APS001F.
Concurrent chemotherapy or targeted anti-cancer agents, other than intrathecal therapy
Subjects who have received prior PSA, MUC1, and/or brachyury-targeted immunotherapy (e.g. vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment
Patients cannot be on a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide); they can’t be on telotristat ethyl; previous use is acceptable if the patient has been off for over one month
Patients may not have received chemotherapy, targeted therapies, biologic response modifiers and/or hormonal therapy within the last 14 days
Use of any chemotherapy, investigational agents, immunotherapy, or hormonal therapy other than GnRH agonists within 28 days of the start of treatment on protocol. Use of bone targeted agents including bisphosphonates and RANK ligand inhibitors is allowed if on stable dose; Xgeva or Zometa cannot be started within 28 days of initiating study therapy.
Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy
Prior therapy targeted to EGFRvIII
Must not have received an antineoplastic targeted therapy within 14 days.
The subject has received cytotoxic chemotherapy, molecular targeted therapy, or immunotherapy within 21 days before the first dose of study drug (trametinib)
Patients with known ROS1 mutations who have not received prior targeted therapy
Prior treatment with any therapy that is targeted to B cell maturation antigen (BCMA) or any other CD3-redirecting drug
Patients are eligible if they undergo a targeted treatment recommended by the Molecular Tumor Board, excluding clinical trials
Eligibility criteria for additional lines of MTB recommended targeted therapy:\r\n* Patient’s disease has progressed on the first line (or previous line) of MTB recommended targeted therapy or patient could not tolerate the targeted treatment\r\n* Patients must meet eligibility criteria as defined previously
Tumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such targeted therapy
Tumor with mutation that is known to be sensitive to FDA approved targeted therapy but has not yet received such therapy
Prior treatment with at least one standard chemotherapy regimen or targeted agent prior to enrollment
No prior chemotherapy, targeted therapy, or immunotherapy for mesothelioma
Has received any prior anticancer therapy for mesothelioma (no prior chemotherapy, immunotherapy, or targeted therapy)
Patient must be willing to consent to MSKCC protocol 12-245 (“Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy”)
Patients who have had chemotherapy, immunotherapy or any targeted therapy within 7 days prior to anticipated SRS treatment date or those planning for systemic therapy within 7 days following the protocol treatment
No prior receipt of systemic treatment (chemotherapy, targeted therapy, or immunotherapy) for the lesion under consideration of treatment
Patient may be receiving bone targeted agents
Stage 4 non-squamous cell lung cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior
Patient has received at least one prior standard chemotherapy or targeted therapy for treatment of lung cancer
Previous treatment with surgery, radiation, chemotherapy, immunotherapy or any targeted agents are allowed provided that: \r\n* Chemotherapy was administered > 28 days before the start of HD IL-2\r\n* Surgery, radiation, immunotherapy or any targeted agents was administered > 14 days before the start of HD IL-2
Chemotherapy, radiation, or biological or targeted therapy within 3 weeks
Size of the targeted portion of the tumor (i.e. prescribed ROT) is less than 2.5 cm in diameter (8 cm3 in volume). The non-targeted tumor tissue may exceed the targeted volume.
Has been treated with more than two lines of cytotoxic chemotherapy or molecular targeted therapy or interferon for Lung NET
Prior treatment with a Mucin 16 (MUC16)-targeted therapy
Patients with genomic tumor aberrations should have received prior treatment with an FDA-approved targeted therapy (if available)
Patient with NRS (0-10 scale) pain score ? 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ? 4) irrespective of medication
No radiation therapy to targeted (most painful) tumors in the past two weeks
The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
Targeted tumor is in the skull
Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks
Targeted (most painful) tumors:
Size of the targeted portion of the tumor (i.e. prescribed Region Of Treatment) is less than 2.5 cm in diameter or 8 cm3 in volume. The non-targeted tumor tissue may exceed the targeted volume.
Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < 2 weeks prior to study Day 1
Prior systemic chemotherapy, molecularly targeted therapy, or radiation therapy for the current OPSCC diagnosis
No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed)
Prior chemotherapy, targeted biological therapy (e.g. sorafenib), surgery, transarterial chemoembolization (TACE), ablation for present disease is acceptable
Subjects with BRAFV600 wild-type tumors must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy given in a non-adjuvant setting for unresectable stage IIIB to IVM1c melanoma.
Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
At least 2 weeks from end of targeted therapy
Patients who have received prior administration of an Aurora A kinase targeted agent (including alisertib) are not eligible
Receipt of prior immunomodulatory agents, including programmed death-1 or PD-L1 targeted therapy or cytotoxic T-lymphocyte-associated antigen 4 targeted therapy including ipilimumab (this exclusion criterion does not apply to participants enrolled in Expansion Cohort A)
Prior therapy with any molecular targeted drugs (for lung cancer)
Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
Prior administration of an aurora A kinase-targeted agent, including alisertib
Prior chemotherapy, immunotherapy, or targeted therapy is allowed as long as it did not include dasatinib
Patients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (e.g. AML)
Commercially available, molecularly targeted therapies (e.g., dabrafenib, trametinib, vemurafenib, imatinib) taken within 7 days prior to lymphodepletion
Phase1: Treatment naïve: Must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy for unresected stage IIIB to IV melanoma.
AR targeted agents (including GTx-024, enzalutamide or other AR targeted therapies)
Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol
Subjects who have received prior CEA, MUC1, and/or brachyury-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 4 weeks prior to enrollment
Any prior chemotherapy, targeted/biologic therapy, or radiation for treatment of the participant’s gastric or GE junction cancer
Concurrent treatment with commercial agents or other agents with the intent to treat the participant’s malignancy, including endocrine therapy, chemotherapy, and/or targeted therapy, with the exception of bisphosphonates and GnRH agonists
Received any chemotherapeutic or targeted agent (approved or investigational) for NSCLC within 2 weeks of initiation of pacritinib (with the exception of erlotinib)
Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment (day 1 visit)
Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy
Prior treatment with Aurora A-targeted agents, including MLN8237
Prior treatment with irinotecan or aurora A-targeted agents, including MLN8237
Patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies (ipilimumab) or pharmaceutical compounds are excluded.
Treatment with a single course of gefitinib(Iressa®) or erlotinib (Tarceva®), or other small molecule or targeted therapies, or monoclonal antibody therapy (excluding docetaxel) will be considered and count as prior chemotherapy.
Concurrent chemotherapy, or targeted anti-cancer agents, other than hydroxyurea
Any prior chemotherapy, targeted/biologic therapy, or radiation for treatment of the patient's pancreatic tumor
Biologic or other approved molecular targeted small molecule inhibitors should be washed out 1 week before apheresis and must be completed at least 1 week prior to pre-infusion lymphodepletive chemotherapy.
Concurrent treatment with commercial agents or other agents with the intent to treat the participant’s malignancy, including endocrine therapy, chemotherapy, and/or targeted therapy, with the exception of bisphosphonates and GnRH agonists
Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy
Any number of prior cancer treatments, including investigational agents, chemotherapy, hormone therapy, or targeted therapy are allowed
Concurrent investigational treatment, chemotherapy, or targeted therapy; prior chemotherapy, hormonal therapy, targeted therapy, and investigational agents are allowed but all toxicities grade >= 2 must have resolved by the time of study commencement (except alopecia)
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment
Prior administration of an aurora A kinase-targeted agent, including alisertib
Chemotherapy and other investigational therapies (targeted or immunotherapy) will require a 3-week washout period before treatment initiation
Participants who received prior treatment with erlotinib or other EGFR-targeted agents
Prior treatment with any investigational or targeted therapies
Patients on chemotherapy &/or targeted agents for palliation
Targeted tumor(s) are accessible to the ExAblate device
Prior use of chemotherapy (targeted therapy such as erlotinib and crizotinib will be allowed; if a patient was receiving erlotinib and/ or crizotinib as targeted therapy before entering the study they should discontinue that medication 2 weeks before day 1 of the study)
Prior treatment with MUC16 targeted therapy (e.g., oregovomab [OvaRex] or abagovomab) including DMUC5754A
Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
Has received prior treatment with ONT-10 or varlilumab, or prior treatment with other MUC1 vaccines or CD27-targeted agents
Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
Patients must be on a stable dose of specific targeted therapy (erlotinib or crizotinib) for >= 28 days prior to initiation of ipilimumab/nivolumab
Patients may be on specific targeted therapy (erlotinib or crizotinib) as long as they have not had disease progression
NET subjects must have progressed on or been ineligible for treatment with somatostatin analogues (SSA) and at least one other FDA-approved targeted therapy (everolimus or sunitinib).
Prior administration of an aurora A kinase-targeted agent, including alisertib
Received the last administration of an anticancer targeted small molecule therapy (e.g. sunitinib, sorafenib, pazopanib, axitinib, everolimus, temsirolimus, ridaforolimus) =< 14 days prior to study registration or have not recovered from the side effects of such therapy
Targeted (treated) tumor is in the skull
Targeted (most painful) tumor Not accessible to ExAblate
The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
Patients with metastatic cancers who are considering or pursuing additional palliative therapy after progressing on at least two prior lines of chemotherapy, immunotherapy, biological or targeted therapies
Prior anticancer chemotherapy or targeted therapy for advanced nccRCC
Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
Received a therapeutic intervention with at least one of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any modality)
Patient may be receiving bone targeted agents
Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy
Will stay in the targeted area in the next 2 years
Patients who are planned to receive either chemotherapy, targeted therapy, immunotherapy, or no additional cancer-directed drug therapy
Patients who have received targeted agents or systemic potentially radiosensitizing chemotherapy within 2 weeks of lung SBRT start
Patients participating treatment trials including targeted therapy, experimental therapy or immunotherapy are also eligible
Patients whose targeted lung lesion is visualized with fluoroscopy
Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
Subject must not have received any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic pancreatic adenocarcinoma, with the following exceptions and notes:
No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment. For all prior anticancer treatment, including radiotherapy or targeted agents or hormonal therapy, a duration of more than 5 half-lives of the targeted/hormonal agents used must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria.
Group A, group B and group C only: Patients not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, targeted therapy, monoclonal antibody therapy including immunotherapy (e.g. PD-1/PD-L1 inhibitors) or targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion 4.
Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
Prior exposure to targeted SYK inhibitors.
Prior CD19 targeted therapy
More than 2 prior treatment regimens for the platinum-resistant/refractory relapsed EOC, FTC, or PTC, defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy.
Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
No previous radiotherapy, chemotherapy or other brain tumor directed therapy other than corticosteroid therapy and surgery
Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed
Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry
No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6
No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration
Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol
Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other therapy while on this protocol
Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
At least 4 weeks since prior treatment (chemotherapy, radiation therapy, hormonal therapy)
Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DHES0815A
Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
Completion of other cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy, surgery) 14 days prior to first dose of protocol therapy\r\n* For patients with breast cancer only:\r\n** May continue ongoing antiestrogen therapy (for example, aromatase inhibitor)\r\n** May continue ongoing human epidermal growth factor receptor (Her)2 directed therapy (for example, trastuzumab)
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
Have not fully recovered from the acute toxic effects of prior anticancer therapy (e.g., chemotherapy, immunotherapy, radiation therapy) or are currently receiving cytotoxic chemotherapy, immunotherapy or radiation therapy. A minimum period of 4 weeks / 28 days is required between the end of prior anticancer therapy and the initiation of TB-403.
Prior treatment of this cancer including:\r\n* Surgery\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Biotherapy\r\n* Hormonal therapy \r\n* Investigational agent prior to study entry
Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with ? Grade 2 alopecia or ? Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.
Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks prior to initiation of study treatment
Concomitant anticancer therapy, systemic immune therapy, or hormonal therapy as cancer therapy
No prior chemotherapy, biologic therapy, hormonal therapy or investigational therapy for this operable breast cancer
Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy)
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions stated in the protocol
Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, or investigational agents; 6 weeks for mitomycin C)
If they are undergoing or have undergone in the past 4 weeks (28 days) any other therapy for their cancer, including radiation therapy and adjuvant therapy
Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol.
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to the initiation of study treatment. The following exceptions are allowed: hormone-replacement therapy or oral contraceptives
Patients who have had chemotherapy, hormonal therapy (except LHRH agonist or antagonist), immunotherapy, radioisotope therapy, or RT within 21 days prior to start of the study agents
Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer (anti-hormonal therapy given as adjuvant therapy for early-stage estrogen receptor (ER) positive breast cancer is not considered cancer therapy for the purpose of this protocol)
Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Patients must have no had adjuvant therapy for the management of endometrial carcinoma; this includes chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; this also pertains to hormonal, vascular, and targeted therapy for the management of endometrial cancer
Has had prior chemotherapy, targeted small molecule therapy, monoclonal antibody therapy, or radiation therapy within 2 weeks prior to on-study date\r\n* Note: If currently receiving hormonal therapy or chemotherapy, this treatment must be stopped at least 2 weeks prior to on-study date; hormonal therapy may be restarted after the restaging scan 1 month after the 8th BATs infusion\r\n* Note: Radiation therapy to the axial skeleton must be completed at least 2 weeks prior to on-study date
Within 28 days before first dose of protocol-indicated treatment:\r\n* Anti-cancer treatment including chemotherapy, radiation, hormonal therapy, targeted therapy, immunotherapy, or biological therapy\r\n* Major surgery requiring general anesthesia; (Note: within this time frame, placement of a central line or portacath is acceptable and does not exclude)\r\n* Receipt of an investigational agent
Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment
Patient can have had prior treatment for HCC including prior surgery, radiation therapy, local-regional therapy (abalation or arterial directed therapies), and systemic therapy including sorafenib or chemotherapy (but not anti-PD-1 or anti-CTLA-4 therapy)
Finished their active cancer treatment (surgery, chemotherapy [chemo] and or radiation) at least 3 months prior to registration; (anti hormonal therapy will not prevent patient from participation as long as he/she can perform mild to moderate physical activities)
Patients who have had anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies or other investigation agents), large field radiotherapy, or major surgery must wait 4 weeks after completing treatment prior to entering the study
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:\r\n* Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging\r\n* Hormone-replacement therapy or oral contraceptives
Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
Prior biological cancer therapy, targeted therapy, or major surgery within 28 days prior to first dose of therapy
Patient who has had chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to the first dose of study drug
Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives, prior to the first dose of ABBV-181 or Rovalpituzumab Tesirine.
Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, immunotherapy and monoclonal antibodies, alternative therapy or investigational therapeutic agents); there is no limitation on the amount of prior therapies allowed; patients with ovarian cancer 4 weeks from previous therapy have been found to have normal monocyte function (unpublished)
Currently receiving other anti-cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization)
Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer
Concurrent or planned use of any other anti-cancer systemic chemotherapy, biological therapy (including hormonal or immune therapy), radiation therapy, or live cancer vaccines
Currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, and surgery and/or tumor embolization) or any investigational drug within 7 days of cycle 1/day 1, 14 days of cycle 1/day 1 for limited palliative radiation, and/or five half-live of an oral therapy\r\n* Corticosteroid therapy started at least 7 days prior to initiation of treatment (prednisone =< 10 mg daily or equivalent) is allowed as clinically warranted); topical or inhaled corticosteroids are permitted
NO prior chemotherapy, radiation therapy or biologic/targeted therapy for current diagnosis of lung cancer
Prior radiation therapy, immunotherapy, chemotherapy or other investigational therapy given for prostate cancer
Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy) within 28 days (6 weeks for nitrosoureas or mitomycin C, and 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment on Study Day 1 of Period A.
No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery other than the anthracycline and cyclophosphamide chemotherapy with or without 5-fluorouracil; treatment for ductal carcinoma in situ is allowed, such as surgery, hormonal therapy and radiotherapy
Liver tumor-directed therapy, hepatic surgery, antibody-based therapy, or immunotherapy must not have been performed < 28 days, chemotherapy < 21 days, and targeted small molecule therapy or hormonal therapy < 14 days prior to enrollment.
Patients must not have received any anti-cancer therapy (cytotoxic chemotherapy, targeted therapy or radiation) within the past 28 days prior to initiation of study therapy
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biologic therapy) other than the ones specified in the protocol; patients must have discontinued the above cancer therapies for 1 week prior to the first dose of study medication; any investigational drugs should be discontinued 2 weeks prior to the first dose of study medication and radiotherapy must have been completed >= 2 weeks prior to initiation of study drug (cycle 1, day 1)
No prior therapy for pancreatic cancer, including chemotherapy, radiation therapy, definitive surgery or investigational therapy
Prior systemic treatments for metastatic disease are permitted but may not be ongoing, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy
Received any of the following for treatment of this cancer (except for the neoadjuvant endocrine therapy specified within this protocol):\r\n* Surgery\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Biotherapy\r\n* Hormonal therapy\r\n* Investigational agent
Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment
No recent treatment for thyroid cancer as defined as:\r\n* No prior RAI therapy is allowed < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 millicurie (mCi) of RAI is not considered RAI therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol; (previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol)\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy on this protocol
Patient who has had chemotherapy, radiation, hormonal, or biological cancer therapy < 4 weeks prior to the first dose of study drug
Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to Cycle 1 Day 1
Patients who have received systemic cytotoxic chemotherapy or approved oral targeted therapy or immunotherapy for 2 weeks, or other investigational agents for 3 weeks (4 half-lives for any oral targeted agents), or radiotherapy to a non-brain site for 2 weeks before initiation of IPdR therapy; patients who have recovered from serious (Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more higher) to grade 1 or less adverse events from the previous therapies are eligible; prior/current/future hormonal therapy and/or bisphosphonates are permitted with no minimum interval to initiation of study therapy; if indicated, patients can receive palliative radiation therapy to a non-brain site concurrent or immediately post-study treatment with no minimum interval to initiation of study therapy
Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy; patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half-life of the agent); patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2
Radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to day 1 of study drug\r\n* For the NSCLC expanded cohort only: palliative radiation therapy =<14 days of day 1 of study drug
Chemotherapy, radiation therapy, or biologic therapy (except trastuzumab) within 28 days prior to initiating treatment on study; endocrine therapy and supportive therapy with bisphosphonates will be allowed
At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be =< grade 1, per the CTCAE version (v)5.0 and must have been completed at least 2 weeks prior to randomization
Liver tumor-directed therapy, hepatic surgery, antibody-based therapy, or immunotherapy must not have been performed < 28 days, chemotherapy < 21 days, and targeted small molecule therapy or hormonal therapy < 14 days prior to enrollment. No radiation to tumor sites during the last 4 weeks.
If they are undergoing or have undergone in the past 4 weeks (28 days) any other therapy for their cancer, including radiation therapy and chemotherapy
Part 2 patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
At the time of enrollment, subjects may not have had any prior systemic therapy for breast cancer, including chemotherapy, targeted biologic therapy, or greater than 3 months of hormonal therapy; similarly, chemotherapy or biologic therapy must not be part of the subsequent treatment plan
Antineoplastic therapy (e.g. chemotherapy or targeted therapy) for other invasive cancer within 5 years before randomization; (for the purposes of this study, hormonal therapy is not considered chemotherapy)
Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy, or immune therapy for the study cancer
Patients must not have received prior radiation therapy (RT), chemotherapy, immunotherapy or therapy with a biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy), or hormonal therapy for their brain tumor; corticosteroid therapy is allowed
Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received FOLFIRINOX must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified
Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
Has received previous high dose (>= 600,000 IU/kg) IL-2 therapy; other prior therapy (in the adjuvant or the metastatic setting) is allowed, including immunotherapy, targeted therapy, chemotherapy, or experimental therapy
At least 2 weeks have passed since prior chemotherapy, biological therapy, radiation therapy, major surgery, other investigational or anti-cancer therapy that is considered disease-directed
Patients must have recovered to at least a grade =< 1 toxicity eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01), or therapy with tyrosine kinase inhibitors within 5 times the half-life of the inhibitors prior to entering the study; patients must be >= 2 weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase 0 study; patients must be >= 1 month since completion of any prior radiation (>= 2 weeks for palliative radiation therapy); however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy\r\n* Prior therapy with topoisomerase I inhibitors is allowed
Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on day +100
Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery or other therapy after step 2 registration
Any approved anticancer therapy, including chemotherapy, or hormonal therapy (except hormone-replacement therapy or oral contraceptives) within 3 weeks of first dose.
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient’s lung cancer occurred more than 12 months after the last day of chemotherapy
Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment (hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for prostate cancer and palliative radiotherapy greater than (>) 2 weeks prior to Cycle 1, Day 1 are allowed)
Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy
Patients must not have received any prior anti-cancer therapy (except for radical or partial nephrectomy noted above) for renal cell carcinoma, including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiation therapy
Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
Any anticancer therapy, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer (anti-hormonal therapy given as adjuvant therapy for early-stage estrogen receptor (ER) positive breast cancer is not considered cancer therapy for the purpose of this protocol)
Would receive study treatment within 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasive investigational device; or is currently enrolled in an investigational study
Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
At least 2 weeks since prior chemotherapy, biological therapy, radiation therapy, major surgery, other investigational, or anti-cancer therapy that is considered disease-directed and recovered from prior toxicities to grade 0-1 at least 2 weeks prior to investigational therapy
Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to beginning study therapy.
Patients receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy, hormonal therapy, and biological therapy) while taking study medication or have previously received talimogene laherparepvec or any other oncolytic virus
Prior chemotherapy or radiation therapy for any cancer
No more than sixty days from final surgery to simulation if no systemic therapy (includes chemotherapy and hormonal therapy) is given
Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy
Use of chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks of the first dose of study drug
Adjuvant therapy (including radiation therapy) within 2 calendar weeks; toxicities from prior therapy for the malignancy should resolve to grade 1 or less
History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy)
Radiation therapy, hormonal therapy, biologic therapy, experimental therapy, or chemotherapy for cancer =< 21 days prior to registration
Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment;
Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy within 2 weeks
Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry
Are receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy or radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks prior to enrollment.
Participants who require active chemotherapy for another cancer; those requiring hormonal therapy or radiation therapy may be considered for enrollment on a case by case basis
Patients may not have received prior cytotoxic chemotherapy; however, nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed; patients may have received prior radiation therapy (including whole pelvic or vaginal brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy must be discontinued at least 2 weeks prior to entry on this study
Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer
Chemotherapy, immunotherapy (including interferon), or biological therapy, radiation therapy and/or surgery within 4 weeks prior to first dose of study drug.
> 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this malignancy\r\n* NOTE: if the patient has received < 4 weeks of such therapy but is still receiving it at the time of entry into the study, patient must temporarily stop the therapy; the therapy can re-start only after 12 weeks of T-DM1 has been administered
Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer
Patient must not have received any cancer-directed therapy (e.g., surgery, chemotherapy, radiation therapy, biologic therapy) for the index diagnosis
Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of cycle 1/day 1 with the following exceptions:\r\n* Limited palliative radiation is allowed if completed >= 2 weeks of cycle 1 day 1 (C1D1)\r\n* Corticosteroid therapy (prednisone or equivalent =< 20 mg daily) is allowed as clinically warranted as long as the dose is stabilized at least for 7 days prior to initial dosing; topical or inhaled corticosteroids are permitted\r\n* Patients currently taking ibrutinib do not need to undergo a washout period
No recent treatment for thyroid cancer as defined as: \r\n* No prior 131I therapy is allowed < 6 months prior to initiation of therapy on this protocol; a diagnostic study using < 10 mCi of 131I is not considered 131I therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol; (previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol) \r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to the initiation of therapy on this protocol
Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
Radiation, chemotherapy, immunotherapy or any other systemic anticancer therapy =< 3 weeks prior to initiation of therapy
Patients who have received prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to registration are not eligible for participation
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Participants who have received anti-cancer therapy (including chemotherapy, biological therapy, investigational agents, hormonal therapy, or other anti-cancer therapy) or radiotherapy within =< 14 days prior to the planned initiation of investigational products, or those who have not recovered to grade =< 1 from adverse events due to their most recent therapy (excepting alopecia)
Patients receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy and biological therapy) while taking study medication; however, patients receiving CDK4/6 inhibitor ormTOR inhibitor as a standard of care while on study is permitted
Any prior chemotherapy, radiation therapy, or biologic therapy (“targeted therapy”) for treatment of the patient’s pancreatic tumor
Prior chemotherapy or radiation therapy for any cancer
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
Prior and concurrent therapy:\r\n* Chemotherapy: At least four weeks since prior cytotoxic chemotherapy or 6 weeks since nitrosoureas or mitomycin\r\n* Molecular targeted agents including monoclonal antibodies and tyrosine kinase inhibitors: At least two weeks since last therapy\r\n* Endocrine therapy: Subject may be remain on luteinizing hormone-releasing hormone (LHRH) antagonist therapy for prostate cancer if tumor progression has been confirmed\r\n* Radiotherapy: At least 3 weeks since most recent radiotherapy\r\n* Palliative radiotherapy to localized painful lesions is acceptable when the subject is on study: At least one week after completion of radiation therapy (RT) and recovery from associated toxicities before restarting ARQ 761; irradiated lesions will not be evaluable for response\r\n* Other investigational therapy: At least four weeks since any other investigational therapy\r\n* Concurrent therapy: No other concurrent anticancer or investigational therapy permitted except as noted above
Prior therapy:\r\n* Prior trastuzumab is allowed for all cohorts\r\n* Prior capecitabine is NOT allowed for participants enrolled to cohorts 3a/3b\r\n* Prior lapatinib is allowed for cohorts 1, 2, 3b but NOT cohort 3a\r\n* No prior therapy with neratinib is allowed\r\n* There is no limit to the number of previous lines of therapy (including chemotherapy, trastuzumab, and endocrine therapies) at least 2 weeks washout period post chemotherapy, any prior protocol therapy, lapatinib, other targeted or biologic therapy, or radiation therapy is required prior to study entry\r\n* No washout is required for hormonal therapy but concurrent hormonal therapy is not allowed for patients on study; the only exception to this is longstanding ovarian suppression in pre-menopausal patients, if this has been started >= 6 months prior to study enrollment; other hormonal therapies are not allowed while patients are on study
Any of following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy or biological therapy
Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives, or gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of ipatasertib. Exceptions are kinase inhibitors approved by local regulatory authorities, which may be used within 2 weeks prior to initiation of ipatasertib, provided that any clinically-relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor
Completed cancer specific therapy (including surgery, radiotherapy and/or chemotherapy) a minimum of 4 weeks prior to entry; (subjects with hormone receptor positive breast carcinoma maintained on hormonal therapy following chemotherapy and radiation are eligible)
Anti-Cancer therapy including chemotherapy, radiation-therapy, immunotherapy, biologic therapy or major surgery within 14 days prior to start of study treatment (Note: Dabrafenib monotherapy within 14 days prior to starting combination therapy is allowed for crossover subjects in Cohort A);
Systemic anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ARQ 087
Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
Any systemic anti-cancer therapy (including hormonal therapy), radiation, or experimental agent =< 2 weeks of first dose of study treatment
No prior therapy for the tumor, including extensive surgery, radiation therapy, chemotherapy, immunotherapy, targeted therapy or any other investigational agents; surgical biopsy prior to beginning the study is allowable
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, or immunotherapy
Received anti-tumor therapy (chemotherapy, investigational product, radiotherapy, retinoid therapy, or hormonal therapy) within 2 weeks (less than 14 days) prior to C1D1 with no residual toxicity >Grade 1; antibody therapy, molecular targeted therapy within 5 half-lives prior to C1D1
Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy or hormonal therapy) within 4 weeks prior to C1D1.
Patients may not have received any prior chemotherapy, biologic therapy or radiation therapy for management of their disease; chemotherapy or biologic therapy administered for treatment of another primary malignancy are permitted if treatment was greater than 5 years ago
Patients who are receiving any chemotherapy, biologic therapy, radiation therapy or any investigational agent
No prior treatment (irradiation, chemotherapy, hormonal, immunotherapy or investigational, etc.) for breast cancer excluding therapy for ductal carcinoma in situ (DCIS); subjects receiving hormone replacement therapy (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy
Anti-neoplastic treatment for KS (including chemotherapy, radiation therapy, local therapy including topical fluorouracil [5-FU], biological therapy, or investigational therapy) within four weeks of enrollment
Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of study treatment.
Any of the following for treatment of this cancer including:\r\n* Surgery\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Biotherapy\r\n* Hormonal therapy\r\n* Investigational agent prior to study entry
At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.
Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer; patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study; patients may not have received anthracycline-based chemotherapy in the past; patients with history of ductal carcinoma in situ (DCIS) are eligible if there were treated with surgery alone
Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study and must have evidence of stable or progressive disease to be eligible
Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 14 days of randomization
All previous cancer therapy including chemotherapy, radiation, hormonal therapy and surgery, must be discontinued ?2 weeks prior to registration.
Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous NSCLC
Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to Day 1
Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DLYE5953A
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC
Fewer than 21 days since last anti-tumor therapy, including chemotherapy, biologic except trastuzumab, experimental, immune, radiotherapy for the treatment of breast cancer, with the following exceptions:\r\n* Hormone therapy \r\n* Palliative radiation therapy involving =< 25% of marrow-bearing bone is allowed if completed within >= 14 days prior to first study treatment
No prior chemotherapy, hormonal therapy, or radiation therapy for this cancer
Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ? 3 weeks prior to initiation of therapy
Patients must be >= 4 weeks since completing their prior therapy (including surgery, radiation therapy or investigational therapy [including targeted small molecule agents]); all previous clinically significant treatment-related toxicities have resolved to =< grade 1; patients must be >= 4 weeks since prior therapy with an anti-androgen (e.g. casodex, flutamide, enzalutamide or nilutamide)
Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within 4 weeks prior to administration of the investigational product (IP) (6 weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ? 1 (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
Prior therapy requirements: \r\n* At least >= 1 prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy\r\n* At least 4 weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy\r\n* At least 2 weeks from completion of prior radiation therapy\r\n* At least 4 weeks from last dose of prior investigational therapy\r\n* Not receiving any current anti-cancer therapy\r\n* At least 4 weeks from last dose of interferon or IL-2 therapy\r\n* At least 8 weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and anti-programmed cell death 1 (PD1)\r\n* At least 4 weeks from last dose of prior other biologic agents
Prior therapy: The subject's disease (i.e. cancer, neurofibromatosis type 1 [NF-1] with plexiform neurofibroma [PN], or Langerhans cell histocytosis [LCH]) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities. All subjects must have recovered to grade <=1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment. Prior therapy includes; myelosuppressive chemotherapy, differentiating agents/ biologic response modifiers (small molecules, antibodies, viral therapies) (anti-cancer agent), non-myelosuppressive anticancer agents, investigational agent, radiation therapy, stem cell transplantation or infusion, number of prior treatment regimens, colony stimulating factors, corticosteroids.
Patients going on Arm 1 or combination dose cohort must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment, with the exceptions as mentioned in the protocol
Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day 1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC
Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1
Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment
A concurrent active cancer that requires non-surgical therapy (e.g., chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there is no active disease within 1 year of the first dose of PLX3397.
Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1
Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer
Patients with a prior history of chemotherapy, hormonal ablation therapy and/or radiation therapy.
No prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer
No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for MM, unless locoregionally recurrent; if recurrent, no prior medical or radiation therapy is allowed for the latest recurrence
Any approved systemic anti-cancer therapy (including chemotherapy) or hormonal therapy within 3 weeks prior to initiation of study treatment
Use of chemotherapy, biologic therapy, radiation therapy, erythropoietin or related erythropoiesis stimulating agents, or investigational therapy within 2 weeks of the first dose of study drug
Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy)
No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy; prior palliative radiation permitted; prior adjuvant chemotherapy/radiation is permitted
Have not received chemotherapy or radiation for > 14 days (advanced cancer patients receiving hormonal therapy, immunotherapy, or targeted therapy that does not come with a recommendation for prophylactic anti-emetic therapy are eligible)
Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapy are allowed
Undergoing chemotherapy, hormonal therapy, or targeted therapy
Treatment with chemotherapy, immunotherapy, or biologic therapy as anti-cancer therapy within 3 weeks, or treatment with endocrine therapy or kinase inhibitors within 2 weeks, prior to starting study treatment, except for premenopausal participants with breast cancer who may continue Gonadotropin-releasing hormone agonist therapy
Patients must not be planning to receive other biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other therapy while on this protocol; palliative radiation therapy or surgery can be considered for symptomatic non-target lesions after discussions with the study team
Post active breast cancer therapy (e.g. surgery and/or chemotherapy and/or radiation therapy), but may still be undergoing maintenance cancer therapy and must be within 4 years of end of active treatment.
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 4 weeks OR has received systemic therapy and reports that they are still experiencing side effects or complications of the cancer or cancer treatment
For those receiving chemotherapy/infusional therapy, patients have to enroll during the 4 weeks prior to or on the day of treatment initiation; for those enrolling during hormonal therapy and/or radiation, patients must enroll within 6 months of diagnosis of breast cancer, defined as the date of initial biopsy; patient may be receiving hormonal therapy, radiation therapy, or both at the time of enrollment
Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
Must be considering or currently receiving any kind of cancer treatment (any line), including but not limited to hormonal treatment, chemotherapy, monoclonal antibody therapy, or targeted therapy; patients who are considering therapy are eligible even if they ultimately choose not to be on therapy; patients with a history of any previous cancer treatment, including radiation and/or surgery are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
Patients who have completed treatment for breast cancer and are within two years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapies in the adjuvant setting are allowed
Currently between 1.0 and 4.99 years from the completion of active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention)
Currently undergoing chemotherapy treatment or within 12 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)\r\n* Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 12 weeks of end of radiation)\r\n* Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
Close proximity in time to treatment with high-dose chemotherapy, stem-cell rescue, differentiation therapy, immunotherapy, thoracic or mediastinal radiotherapy, hormonal therapy, biologic therapy, herbal cancer therapy, hematopoietic growth factor, investigational therapy, or St. John's wort according to protocol-defined criteria prior to initiation of study drug
Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 2 weeks of cycle 1/day 1 with the following exceptions:\r\n* Corticosteroid therapy (prednisone or equivalent =< 20 mg daily) is allowed as clinically warranted as long as the dose is stabilized at least for 7 days prior to initial dosing; topical or inhaled corticosteroids are permitted\r\n* Patients who may experience clinical deterioration may start therapy after a shorter washout period with prior approval by the principal investigator (PI)
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions provided in the protocol
Receiving chemotherapy, biotherapy, or radiation therapy for cancer
Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).
Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy
Are currently undergoing treatment for cancer with chemotherapy, hormone therapy, radiation, or biological therapy
Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)
Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days
Treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed); patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy
No recent treatment for thyroid cancer as defined as:\r\n* No prior 131I therapy is allowed < 6 months prior to initiation of therapy on this protocol; a diagnostic study using =< 400 MBq of 131I is not considered 131I therapy\r\n* No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol; (previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol)\r\n* No chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is allowed < 4 weeks prior to inclusion on this protocol
No plans to undergo prostate cancer (PCa) therapy (with hormone therapy, chemotherapy, radium therapy, or external radiation) between the two study exams
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biological therapy) other than the ones specified in the protocol; any other investigational drugs should be discontinued 2 weeks prior to the first dose of study medication
Patients cannot have hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of registration; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is not considered cured is acceptable)
Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage (or disease setting); patient must not have had any systemic therapy (chemotherapy or combination regimens) in the 180 days just prior to registration; prior biologic therapy, immunotherapy, and hormonal therapy are allowed
Completion of prior chemotherapy, biologic therapy, immunotherapy, or radiation therapy at least 4 weeks prior to enrollment.
Prior chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy (RT), chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy,radiation therapy ( RT), chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
Has received prior targeted small molecule therapy, radiation therapy or systemic chemotherapy for urothelial bladder cancer including neoadjuvant chemotherapy\r\n* Prior intravesical chemotherapy or intravesical immunotherapy is permissible, however, no prior intravesical therapy is permitted within 4 weeks of study enrollment; adjuvant therapy is not permitted
Any concurrent chemotherapy, immune therapy, biologic, hormonal therapy for cancer treatment
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Biologic therapy
2. Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for cancer treatment. Concurrent use of hormones for non-cancer related conditions is acceptable (e.g., insulin for diabetes & hormone replacement therapy). Local treatment of isolated lesions for palliative intent is acceptable;
Treatment with any of the following anti-cancer therapies =< 14 days prior to registration:\r\n* Radiation therapy\r\n* Surgery or tumor embolization\r\n* Chemotherapy, immunotherapy\r\n* Biologic therapy\r\n* Investigational therapy\r\n* Hormonal therapy
Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib)
Has received the prohibited therapy (e.g., concurrent anti-cancer therapy including but not limited to: chemotherapy, radiation, hormonal, or immunotherapy) ?14 days prior to first planned dose of AC0010MA.
Subject has received anti-cancer chemotherapy, immunotherapy, hormonal (with the exception of hormones for thyroid conditions or estrogen replacement therapy [ERT], or any investigational therapy) within 21 days of enrollment
Subjects must not have had prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy.
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Concurrent anticancer therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy)
Patients who are currently being treated with cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) other than the trial therapy.
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib)
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment; the washout period between radiation therapy or tumor embolization is two weeks; given the refractory nature of the study population, the washout period between study treatment and prior chemotherapy or biological therapy, will be three weeks prior to use of regorafenib
Patients receiving other treatment for breast cancer (includes standard hormonal therapy, chemotherapy, biologic therapy, immunotherapy, or radiation therapy). Patients receiving chronic bisphosphonate or denosumab therapy are eligible.
Is receiving concurrent chemotherapy, investigational drug, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Patients receiving any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer (concurrent use of hormones for noncancer-related conditions [e.g., insulin for diabetes and hormone replacement therapy] is acceptable) Patients must have completed any previous cancer-related treatments before enrolment. The following intervals between the end of the prior treatment and first dose of study drug must be observed:
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment; concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable
Concurrent anticancer non protocol directed therapy (e.g. chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy)
have received chemotherapy, hormonal therapy, biologic therapy, immunotherapy or radiation therapy within 14 days prior to the planned start of study treatment.
Any concurrent chemotherapy, investigational product (IP), biologic or hormonal therapy for cancer treatment; concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable
Any of the following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy, or biologic therapy
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy, including investigational agents for their disease
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) =< 7 days prior to treatment
Ongoing radiation therapy, chemotherapy, hormonal therapy, immunotherapy, or biologic therapy directed at the tumor; those patients with a plexiform neurofibroma requiring treatment will be eligible
Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
Prior or concurrent systemic anticancer therapy for BC (immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).
Concurrent chemotherapy, hormonal therapy, immunotherapy regimens, or radiation therapy, standard or investigational
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable
Any concurrent chemotherapy, biologic or hormonal therapy for cancer treatment is not permitted within 28 days of registration\r\n* Note: Prior immunotherapy is not permitted\r\n* Note: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Any concurrent chemotherapy, immunotherapies or biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable; in addition, local treatment (eg, by local surgery or radiotherapy) of isolated lesions for palliative intent is acceptable beyond the first cycle with prior consultation and in agreement with the principal investigator (PI)
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g. insulin for diabetes and hormone replacement therapy) is acceptable
Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment, concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Is currently participating and receiving study therapy or concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment at the time of administration of first dose of trial treatment; continuation of hormone replacement therapy is permitted; stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a gonadotrophin releasing hormone [GnRH] agonist), ovarian, or breast cancer are not exclusionary
Concurrent treatment with any anticancer agent, including chemotherapy, immunotherapy, or biologic therapy; in breast cancer patients, concurrent use of hormonal therapy (but not trastuzumab) is acceptable provided hormonal therapy was initiated more than 30 days prior to treatment on this study
Patients who are receiving concurrent non-protocol anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or tumor embolization) are to be excluded
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or hormonal therapy).
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
Patients taking any other concurrent approved or investigational anti-cancer therapy (e.g. chemotherapy, immunotherapy, targeted or biologic therapy)
Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy [Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy =< 14 days prior to registration
Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day
Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
Excluded therapies and medications, previous and concomitant\r\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib)\r\n* Prior use of regorafenib\r\n* Concurrent use of chemotherapy, radiotherapy or another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)\r\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication\r\n* Use of any herbal remedy (e.g. St. John’s wort [Hypericum perforatum])
Has any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for invasive malignancy within 2 years. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable.
Concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or any other biologic therapy)
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment regorafenib; however, the palliative radiation therapy (XRT) to non-targeted lesions is allowed
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, biological therapy and hormonal therapy) while taking study medication
Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, tumor embolization, or biologic therapy including pertuzumab, but except IV trastuzumab or hormonal therapy, if patient is already being treated with either of the two agents)
Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib).
Concurrent chemotherapy, hormonal therapy, immunotherapy regimens, or radiation therapy, standard or investigational
Receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy
Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment; concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed; palliative radiation to non-target lesions is also allowed
Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
Concurrent anti-cancer therapy =< 4 weeks from registration (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)
Excluded therapies and medications, previous and concomitant:\r\n* Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, anti-HER2 targeting therapies, or tumor embolization) other than Ra 223 dichloride; concurrent external beam radiation therapy is permitted\r\n* Prior use of Ra-223 dichloride\r\n* Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than the protocol based treatment; LHRH agonist or antagonist therapy and bisphosphonates or denosumab are allowed
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment
Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment; concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed; palliative radiation to non-target lesions is also allowed
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)
Patients currently receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization)
Concurrent systemic and local anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib
Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:
Prior treatment with any of the following anti-cancer therapies for treatment of their renal cell carcinoma (RCC):\r\n* Radiation therapy, surgery or tumor embolization\r\n* Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 28 days of starting study treatment; palliative radiation is allowed
Other concurrent anti-tumor, chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational
Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment.
Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment.
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 3 weeks of starting study treatment
Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the protocol-mandated 4-week drug holiday.
Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
Concomitant chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy
Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.
Concurrent anti-cancer therapy (chemotherapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib)
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy [other than that specified by the protocol], surgery, immunotherapy, biologic therapy including lapatinib, bevacizumab, tyrosine kinase inhibitors other than sorafenib or tumor embolization); trastuzumab will be allowed to continue for human epidermal growth factor receptor 2 positive (HER2+) patients
Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy
Treatment with prohibited medications (eg, concurrent anti-cancer therapy including other chemotherapy, radiation (local radiation for palliative care is permitted), hormonal anti-cancer treatment, biologic therapy, or immunotherapy) < 28 days prior to the first day of study treatment
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
Patients who have received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian or primary peritoneal cancer are not eligible
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy).
Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormonal therapy for treatment of cancer;
Anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 4 weeks prior to entering the study (signing of consent form) or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients on hormonal or bisphosphonate treatment for non-cancer related conditions are eligible
Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions.
Patients must not have received prior radiation therapy, systemic chemotherapy, immunotherapy, therapy with biologic agents or hormonal therapy for their brain tumor
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than regorafenib
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
No prior treatment involving irradiation, hormonal therapy, immunotherapy, investigational therapy, and/or other concurrent agents or therapies for ovarian cancer
Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy
Received treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment; prior and concurrent hydroxyurea is permitted
Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
Patients that have previously received an ALK TKI or PD-1/PD-L1 therapy, and patients currently receiving cancer therapy (i.e., other targeted therapies, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization).
Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
Prior treatment with immunotherapy
Chemotherapy, immunotherapy or anticancer agents within 4 weeks
Immunotherapy
No prior immunotherapy allowed or prior alkylating agents or prior radiation to the brain
Prior immunotherapy is allowed.
Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.
Concurrent immunotherapy is allowed
Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
Immunotherapy less than or equal to 4 weeks prior to registration
Prior immunotherapy including sipuleucel-T
No prior exposure to immunotherapy agents
Prior treatment with any immunotherapy
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
Patients receiving immunotherapy for non-cancer related treatment within < 4 weeks of first planned dose of study treatment will be excluded.
Received chemotherapy/immunotherapy in the last 4 weeks
Concomitant chemotherapy, radiation therapy, or immunotherapy
For post immunotherapy patients with NSCLC all of the following apply:
For other post immunotherapy patients all of the following must apply:
?28 days for a prior immunotherapy. No prior therapy with check point inhibitors, costimulatory agonists or immunomodulatory agents is allowed.
Actively receiving chemo-immunotherapy
Patients who have received any prior immunotherapy
Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study
Patients that have undergone Tyrosinase immunotherapy
Immunotherapy-naive.
Prior treatment with adenovirus-based vectors immunotherapy
Cohort #1: received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy for patients with DLBCL; monotherapy rituximab or other CD20-directed immunotherapy prior to frontline chemotherapy, as maintenance therapy, and radiotherapy in a limited field or as a part of the frontline treatment plan are permitted; last treatment dose should be 3 weeks before start of study treatment
Chemotherapy or immunotherapy within 3 weeks prior to start of hu3F8
History of prior immunotherapy within the last 3 years (immunotherapy allowed for lead-in cohort in castration resistant disease)
Prior immunotherapy including sipuleucel-T
Chemotherapy or immunotherapy =< 28 days prior to registration
Patients may have had no more than one prior line of chemotherapy or immunotherapy in the metastatic setting; at least 14 days must have elapsed from the last chemo/immunotherapy administration until the start of protocol treatment, and patients must have recovered from the side effects of any of these agents
Received systemic treatment for cancer, including immunotherapy, within 28 days prior to initiation of conditioning chemotherapy administration within this protocol
Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration.
Patients may have received prior immunotherapy
Prior chemotherapy or immunotherapy will be allowed if new or persistent measurable site(s) of disease are present
Prior immunotherapy or chemotherapy is allowed as long as > 14 days prior to enrollment
Chemotherapy or immunotherapy within 3 weeks prior to the first dose of vaccine
Patients with exposure to prior immunotherapy are not eligible
Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication.
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
Ongoing systemic therapy for prostate cancer including, but not limited to:\r\n\t* Immunotherapy (e.g. sipuleucel-T, ipilimumab)\r\n\t* Non-protocol prescribed chemotherapy (e.g. cabazitaxel)
Be within 6 months (+/-1 week) between last dose of an immunotherapy agent and study enrollment\r\n* Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation
Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study).
Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;
Received intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study treatment
Immunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)
Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period
Previous use of indoximod or tergenpumatucel-L immunotherapy.
Patients that have previously progressed on immunotherapy such as ipilimumab will be eligible
Previous chemotherapy/immunotherapy within 3 weeks before study entry
Chemotherapy, biologics, immunotherapy, vaccine, cytokine therapy within 4 weeks prior to enrollment
Chemotherapy, radiation, or immunotherapy, within 2 weeks prior to study entry, other than those specified in the inclusion criteria (hydroxyurea and hypomethylating agents)
Patients who have had any prior treatment for CLL, including chemotherapy, corticosteroids, biologic therapy, or immunotherapy are NOT eligible for participation
Patients must not have any significant toxicity associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy, per principal investigator (PI) discretion
Patients who have received prior immunotherapy
No chemotherapy or immunotherapy for a minimum of three weeks prior to start of hu3F8
Prior neurologic toxicity to previous immunotherapy
Those receiving prior immunotherapy must meet all of the following conditions:
Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.
Patients who have received prior immunotherapy
Prior treatment with other immunotherapy, including antibodies, is allowed
>= 3 weeks between completion of chemotherapy or immunotherapy and first (1st) vaccination
Has had prior chemotherapy, radiation therapy, or immunotherapy for the diagnosis of iBCL
Subjects who have received prior immunotherapy may be eligible
Less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy. However, hydroxyurea is permitted up to 24 hours before the study is initiated;
Concurrent immunotherapy (including monoclonal antibodies),during or within 30 days prior to start of study drug
Patients must have received previous systemic therapy to include: a regimen of chemotherapy, immunotherapy including anti-PDL or anti-PD-L1 therapies, combined chemotherapy and immunotherapy, provided treatment was discontinued >= 2 weeks prior to initiation of treatment on the present protocol
Treatment with prior chemotherapy, monoclonal antibodies, other protein or peptide therapeutics or anticancer immunotherapy within 21 days of the first dose of study drug
Systemic chemotherapy or immunotherapy within 14 days of enrollment;
Antibodies or immunotherapy within 6 weeks before the first dose of study treatment.
Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
Prior immunotherapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy\r\n* Myelosuppressive chemotherapy: must not have received chemotherapy within 2 weeks of enrollment and within 2 week of starting protocol therapy\r\n* Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy for both enrollment on study and for commencement of protocol therapy\r\n* Immunotherapy: patients may not have received immunotherapy within 3 weeks of enrollment and within 6 weeks of commencing protocol therapy
Prior investigational immunotherapy
Immunotherapy (e.g., tumor vaccine) At least 6 weeks since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)
Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
Prior platinum chemotherapy or immunotherapy
Previous immunotherapy
Any other chemotherapy, immunotherapy or anticancer agents within 2 weeks of the first dose of study treatment.
EXCLUSION FOR TREATMENT: Prior neurologic toxicity to previous immunotherapy
Prior immunotherapy with CRS-207 or any other Listeria-based agent, therapeutic cancer vaccine, or adoptive T cell immunotherapy
Prior immunotherapy will be permitted; however, any prior immunotherapy must be discontinued at least 2 weeks before peptide vaccine administration; non-immunologic therapy may be continued
Systemic anticancer therapy (chemotherapy, “biologics”, immunotherapy) less than two weeks prior to starting radiation
Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
Participation in any other immunotherapy treatment, that in the opinion of the principal investigator would be unsafe to receive further checkpoint blockade immunotherapy.
Receiving concomitant chemotherapy, radiation therapy, or immunotherapy during the duration of treatment on protocol, or within 21 days prior to enrollment
History of prior immunotherapy within the last 3 years
Patient has had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
The patient must not have received any immunotherapy for their brain tumor
Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer
Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
Discontinuation of all prior chemotherapy, immunotherapy, or biological therapy at least 3 weeks prior to the first dose of investigational product is required.
Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy =< 2 weeks prior to day -7 (beginning of loading phase)
Any immunotherapy within 4 weeks of first dose of study drug.
Treatment with chemotherapy, radiation therapy, or other immunotherapy =< 4 weeks prior to registration
Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
Any immunotherapy within 4 weeks of first dose of study drug.
Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy and biologic therapy at least 2 weeks prior to the start of RT.
Receiving concomitant chemotherapy, radiation therapy, or immunotherapy during the duration of treatment on protocol
Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), except the administration of BRAF or MEK inhibitors
Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
History of prior immunotherapy within the last 3 years
Treatment with an immunotherapy within 30 days
Prior sipuleucel-T treatment or investigational immunotherapy.
Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
No chemotherapy or immunotherapy for a minimum of three weeks prior to study enrollment
Previous immunotherapy treatment for metastatic disease in the preceding 2 months; Note: immunotherapy in the adjuvant setting is allowed
Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
ELIGIBILITY PRIOR TO POST-CHEMOTHERAPY IMMUNOTHERAPY:
Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period
Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
Plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy
Prior immunotherapy (e.g. sipuleucel-T), and chemotherapy are permitted (4 week washout period from chemotherapy)
Prior immunotherapy is allowed
At least 2 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational products
Other chemotherapy (e.g., mitomycin-C, nitrosourea) or immunotherapy (e.g., antibody, cytokine) within 4 weeks
Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll. o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids
Prior chemotherapy, immunotherapy, investigational therapeutic agent, or other therapy used to treat HCC within 4 weeks before the first scheduled administration of RO7070179.
Patients receiving systemic anticancer therapy (chemotherapy, “biologics”, immunotherapy) less than 2 weeks prior to starting radiation
Approved anticancer therapy including chemotherapy or immunotherapy.
History of any of the following toxicities associated with a prior immunotherapy:
Immunotherapy for cancer within 4 weeks of initial study treatment
Subjects who have received anti-cancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, immunotherapy, etc.).
Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon, ipilimumab, or IL-2) with progression or persistent disease
Treatment of primary tumor within 4 weeks of Day 1 Week 1 with surgery, radiation, chemotherapy or immunotherapy
Patients must not have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study
No prior chemotherapy, radiation therapy or immunotherapy for DLBCL; a short course (< 2 weeks) of corticosteroids is allowed for symptom control
Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
melanoma: at least 1 prior treatment (including immunotherapy).
CONTROL (HEALTHY) GROUP: Never received chemotherapy, radiation therapy, immunotherapy, or had breast surgery
No recent or planned immunotherapy
Have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years
The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
prior immunotherapy
Immunotherapy: ?42 days after completion of immunotherapy