More than one line of prior chemotherapy for metastatic or locally advanced disease with the following exception:\r\n* Prior neoadjuvant/adjuvant chemotherapy will not count as line of therapy if completed greater than 12 months prior to initiation of chemotherapy regimen for metastatic or unresectable disease
Have documented disease progression following at least 1 and no more than 2 prior systemic regimens for advanced disease (nonresectable or metastatic). Subjects must have received at least 1 gemcitabine- or 5-FU-containing regimen for advanced cholangiocarcinoma. Subjects who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months of completing the therapy.
More than two prior lines (may be combination regimens) of chemotherapy for angiosarcoma (neoadjuvant/adjuvant treatment does not count as a line of treatment)
The maximum time requirement between surgery and randomization must be:\r\n* 3 months (90 days) if no adjuvant chemotherapy was administered\r\n* 8 months (240 days) if adjuvant chemotherapy was administered\r\n* 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization\r\n* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study\r\n* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
Patients must not have received prior cisplatin or poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors; prior carboplatin in the adjuvant/neoadjuvant setting and prior treatment with iniparib is allowed, if completed more than 6 months prior to study entry
Patients must have adequately recovered from surgery and any administered chemotherapy/radiotherapy at the time of randomization (NOTE: adjuvant chemotherapy and/or radiation is not required)\r\n* Minimum time between date of surgery and randomization is 4 weeks (28 days)\r\n* Maximum time allowed between surgery and randomization:\r\n** 3 months (90 days) if no chemotherapy is administered\r\n** 8 months (240 days) if adjuvant chemotherapy was administered\r\n** 10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered
No postoperative/adjuvant systemic therapy
>= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
Patients must meet at least one of the following criteria:\r\n* Disease progression any time after non-steroidal aromatase inhibitor (AI) use in the advanced disease setting\r\n* Relapse while on or within =< 12 months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease\r\n* NOTE: In either setting, treatment with any prior endocrine therapy must be completed >= 2 weeks prior to course 1 day 1 (C1D1) of study treatment with the exception of exemestane which is permitted in the advanced disease setting within =< 4 weeks immediately prior to C1D1; prior adjuvant exemestane is allowed if the disease free interval is > 12 months from the discontinuation of exemestane; prior faslodex, everolimus, palbociclib or other cyclin-dependent kinase (CDK) inhibitor (e.g. ribociclib, abemaciclib) use are allowed and must have been completed >= 2 weeks prior to C1D1; failure to adhere to this washout guideline will result in a protocol violation
Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease
Patients must have progressed radiographically following first line platinum-based chemotherapy, no additional lines of therapy are permitted\r\n* NOTE: Prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy\r\n* Exception for targeted therapy sub-study (Arm T): At least one line of prior chemotherapy or targeted therapy is required, but there is no limit on number of prior treatments
Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment
Completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both; prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed; (for neoadjuvant patients all chemotherapy should be delivered prior to surgery; no further cycles of chemotherapy post-surgery are allowed)
Patients receiving adjuvant radiotherapy within 2 weeks prior to randomization
Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed; patients that have received adjuvant chemotherapy must be registered to screening within 35 days after completing treatment
Prior systemic therapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, adjuvant therapy for stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted.
Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
Interval between the last surgery for breast cancer (including re-excision of margins) or the completion of adjuvant chemotherapy and study enrollment must be =< 56 days (ie, a maximum of 8 weeks)\r\n* Note: Radiotherapy must begin within 10 weeks following the last surgery for breast cancer or the last dose of adjuvant chemotherapy
Patients must not have received prior chemotherapy except for the following circumstances; gemcitabine and capecitabine chemotherapy given in the adjuvant setting is allowed if the recurrence is greater than 6 months from the completion of chemotherapy; radiation sensitizing doses of 5-fluororuracil or capecitabine are allowed as part of adjuvant treatment and recurrence must be documented greater than 6 months from the completion of adjuvant therapy
Prior treatment with =< two prior cytotoxic regimens; prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine; if the only prior cytotoxic therapy was administered in the perioperative i.e. neoadjuvant or adjuvant settings, patient is eligible provided the interval from end of therapy to the diagnosis of metastatic disease is less than one year
Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
A history of prior systemic treatment with gemcitabine or cisplatin. At least six months must have elapsed if gemcitabine or cisplatin was administered in an adjuvant treatment setting.
Prior ipilimumab treatment with the exception of adjuvant treatment completed ?6 months prior to enrollment
Prior therapy is allowed as follows:\r\n* Platinum chemotherapy in the adjuvant setting is allowed, if the last platinum dose was > 12 months before identification of metastatic disease; platinum-based chemotherapy in the metastatic setting is not permitted\r\n* History of prior anthracycline (e.g. doxorubicin, epirubicin) and taxane-based (e.g. paclitaxel, docetaxel) chemotherapy in the neo-adjuvant / adjuvant or metastatic setting is preferred, but not required\r\n* Patients with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy; endocrine therapy must have been completed at least 7 days before study treatment\r\n* Prior radiation is allowed; radiation therapy must have been completed at least 21 days before study treatment\r\n* Prior treatment with Food and Drug Administration (FDA) approved or investigational biologics (other than PARP inhibitors) and novel molecularly targeted therapies, including oral or IV formulations, shall not exclude patients from participation\r\n* For agents with ambiguous categorization, final determination of patient eligibility will be made by the protocol chair prior to enrollment\r\n* Prior PARP inhibitor use is not allowed for this study
No prior systemic treatment for unresectable locally advanced or metastatic disease for the tumor type under study. If prior systemic chemotherapy treatment was given in the adjuvant or neo-adjuvant setting or as part of radiotherapy chemotherapy treatment, disease-free interval after stop of systemic treatment must be more than 6 months for non-squamous NSCLC and more than 12 months for UC;
No prior chemotherapy for locally advanced or metastatic pancreatic cancer\r\n* Patients are eligible if they received adjuvant treatment after surgical resection with single-agent gemcitabine or gemcitabine/capecitabine or 5-fluorouracil/leucovorin that was completed > 12 months before enrollment; similarly, adjuvant radiation +/- chemosensitization with 5-fluorouracil, capecitabine, or gemcitabine is allowed if completed > 12 months before enrollment
Any prior treatment for metastatic breast cancer (excluding radiation therapy for the purpose of ovarian ablation). Note: prior adjuvant therapy with trastuzumab and pertuzumab is permitted after a 6-month window following completion of adjuvant therapy has passed
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation as described above
Must have completed definitive treatment that included surgical removal of the clinically detected MCC metastases (with/without adjuvant radiation therapy as determined by the treating investigator)
Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational agent) for MCC at any time
Previously treated with no more than one line of prior systemic therapy for stage IIIb or IV lung cancer\r\n* For patients who have previously treated one line of prior systemic therapy for stage IIIb or IV lung cancer, they must have exhibited evidence of disease progression clinically and/or radiographically on or after that treatment\r\n* Patients who previously received neoadjuvant, concurrent, or adjuvant chemotherapy for localized NSCLC and then recurred within 6 months of completing chemotherapy will be considered as having received one line of prior therapy; patients who relapse > 6 months after completing chemotherapy as part of neoadjuvant/concurrent/adjuvant therapy for localized disease, and thereafter receive additional one line of chemotherapy at the time of metastatic disease will be eligible\r\n* Maintenance therapy does not count as a separate line of therapy
One of the following must be true:\r\n* Distant disease progression during administration of combination therapy with taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) for metastatic disease; note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible\r\n* Distant disease progression during administration or within 180 days of discontinuing combination therapy with taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) in the adjuvant disease; note: patients who began treatment with this combination and discontinued taxane-based chemotherapy due to intolerability before distant disease progression are eligible\r\n* For patient who received taxane based chemotherapy and anti-HER2 therapy (trastuzumab or pertuzumab) in the neo-adjuvant setting and underwent surgical resection of primary breast disease: distant disease progression during or within 180 days of discontinuing anti-HER2 therapy (trastuzumab or pertuzumab) in the adjuvant setting
Participant has received more than 4 prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy).
First-line patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.
Have progressed during or after completion of first line systemic chemo therapy\r\n* No limit to the number of prior chemotherapy regimens\r\n* Early progression on/after adjuvant chemotherapy counts as first-line therapy
Any number of prior lines of therapy are allowed\r\n* Prior platinum based therapy is allowed in the following settings:\r\n** Treatment in the neoadjuvant and/or adjuvant setting without clear progression of disease\r\n** Treatment in the metastatic setting without clear progression of disease
Prior chemotherapy:\r\n* History of prior therapy with trastuzumab and a taxane, separately or in combination, is required\r\n* Patients must have either received one line of prior therapy for metastatic breast cancer, or have developed a disease recurrence during or within 6 months after completing adjuvant therapy\r\n* No prior treatment with T-DM1 is allowed\r\n* Last dose of chemotherapy must be at least 21 days prior to registration
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Patients may have had neo-adjuvant and/or chemotherapy that must have been completed > 3 months prior to starting first line therapy
Participants who have received prior treatment with exemestane in the metastatic setting or who have recurred within 12 months of adjuvant exemestane
RANDOMIZED PHASE II CLINICAL TRIAL: Patients may have received adjuvant or neoadjuvant chemotherapy with or without carboplatin or gemcitabine before randomization with an interval not less than 12 months since completion of adjuvant/neoadjuvant treatment
Cohort B:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM1 in neo-adjuvant, adjuvant, or metastatic setting\r\n* No limit on prior lines of therapies
Cohort C:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM1 in neo-adjuvant, adjuvant, or metastatic setting\r\n* Maximum of 5 prior lines of therapy for metastatic breast cancer\r\n* Prior treatment with fulvestrant is permitted
Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > 12 months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > 6 months from the end of previous (neo)adjuvant treatment
Must have shown disease progression according to RECIST, version 1.1, following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression according to RECIST, version 1.1, within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting. These subjects will be referred to as chemo-refractory subjects. (Subjects who have shown disease progression according to RECIST, version 1.1 following prior treatment with anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible)
No prior carboplatin unless given in neoadjuvant/adjuvant setting for curative intent and more than 6 months have elapsed since last carboplatin dose; in the case of relapsed ovarian cancer, patients are eligible if more than 6 months have elapsed since last carboplatin dose
For Parts A, B, C, D, E, G and I: Have received prior systemic chemotherapy for metastatic disease. However, the participant may have received prior systemic chemotherapy in the neoadjuvant or adjuvant setting.
For patients with MBC, prior adjuvant chemotherapy and trastuzumab more than or equal to 12 months prior to enrollment are allowed
No prior therapies (except for anti-estrogen therapy) are allowed for the treatment of the newly diagnosed metastatic breast cancer; patients are allowed to have had prior chemotherapy for breast cancer in the adjuvant setting for at least 12 months prior to enrollment into this study; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior nab-paclitaxel as part of their prior treatment regimen, and that they meet all eligibility criteria
ADJUVANT COHORT: At least 4 weeks post completion of adjuvant chemotherapy and radiation therapy if indicated
ADJUVANT COHORT: Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:\r\n* For the 26 patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD 0332991 (C1D1 Ki67 > 2.7% and C1D15 Ki67 =< 2.7%), adjuvant PD 0332991 should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated\r\n* For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD 0332991 (C1D15 Ki67 =< 10%), adjuvant PD 0332991 should be initiated within 6 months or sooner after initiation of adjuvant hormonal therapy.
Biopsy-proven metastatic pancreatic adenocarcinoma with documented radiographic disease progression on or after one or more systemic therapies. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy. Chemotherapy given for at least 4 months as adjuvant after complete response is considered as a first line therapy.
Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy.
Histologically confirmed stage IV NSCLC, with no prior systemic anti-cancer therapy of any kind (including EGFR and ALK inhibitors), prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiation (whichever was given last) occurred at least 6 months prior to enrollment; prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment
Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within 12 months of neoadjuvant/adjuvant treatment.
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive for metastatic disease; patients who have completed adjuvant or neo-adjuvant chemotherapy > 6 months ago are considered treatment naive
Part A: Subjects must have one of the histologically-confirmed solid malignancies listed below, must be clinically disease-free at study entry (i.e., subjects in the adjuvant setting). Subjects will be permitted to complete any standard of care adjuvant therapy prior to study entry, and those not eligible for any standard of care adjuvant treatment, or who decline such treatment, are permitted to consent to this study, as long as all treatment options have been transparently disclosed and documented in the Subject's medical record
progressed during or within 3 months of completing adjuvant chemotherapy. Note: Generally, treatments that are separated by an event of progression are considered different regimens.
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive; patients who have completed adjuvant or neo-adjuvant chemotherapy or immunotherapy > 6 months ago are considered treatment naive
Unresolved toxicity from all radiation, adjuvant/ neoadjuvant chemotherapy, other targeted treatment including investigational treatment
Patients may not have received prior systemic treatment (chemotherapy or targeted therapy) for advanced BTC; prior adjuvant chemotherapy is permitted provided it was completed > 6 months from registration
Prior treatment with docetaxel chemotherapy in the castration-resistant setting. Prior treatment with docetaxel in either the neoadjuvant or adjuvant setting or for hormone sensitive disease (e.g., CHAARTED population) is allowed, as long as therapy was completed > 12 months prior to study registration
Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease
Prior treatment with gemcitabine or platinum-containing compounds, including in the adjuvant setting.
Unresectable advanced and/or metastatic RCC with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic therapy, including treatment in the adjuvant setting
No limit on prior lines of therapy for metastatic disease; prior adjuvant or neoadjuvant chemotherapy does not count as a prior line of therapy as long as completion of the adjuvant or neoadjuvant therapy was more than 1 year prior to patient enrollment
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization and no lingering toxicities are present.
A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered > 6 months prior to randomization.
Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval
Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease
Patients must have failed or are intolerant to one line of systemic treatment but no more than 3 prior lines of systemic chemotherapy for advanced BTC; patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence
Platinum-resistant or -sensitive after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
SPECIFIC FOR INITIATING ADJUVANT PEMBROLIZUMAB: Patient is receiving adjuvant radiation after salvage surgery
Have received at least 1 prior systemic therapy in the metastatic or unresectable disease setting; patients who have recurred within six months of adjuvant chemotherapy are not required to have received an additional line of chemotherapy
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 must be off corticosteroid for at least for 2 weeks before the first neoadjuvant vaccine and for at least 2 weeks prior to the first adjuvant vaccine
Has received at most 1 line of prior non-gemcitabine chemotherapy for metastatic/unresectable disease\r\n* Prior adjuvant gemcitabine, if completed more than 12 months prior to enrollment is not considered as prior line of therapy\r\n* Radiosensitizing chemotherapy will not be considered a prior line of therapy
No prior adjuvant chemotherapy within 1 year of the first treatment day if there is recurrent disease
Previous chemotherapy except adjuvant treatment with progression of disease documented ? 12 months after end of adjuvant treatment
Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy; although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy +/- radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria
Subjects enrolled due to node positive (+) disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy; patients enrolling due to CA 19-9 elevations can enroll any time after adjuvant therapy has completed
Prior cetuximab is allowed in the adjuvant but not in the metastatic setting, but must have been completed at least 6 months before starting this trial
PART I: Adults with HER2+ bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):\r\n* Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor stage\r\n* Tumors that are HER2 1+, 2+ or 3+ by IHC or have a Vysis FISH result >= 1.8\r\n* Status-post primary cystectomy with curative intent\r\n* May or may not have received neoadjuvant cisplatin-based combination chemotherapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n* May or may not have received adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines\r\n* Greater than or equal to 6 weeks s/p primary surgery with curative intent
Phase I and expansion cohort: Up to two prior non-taxane chemotherapy regimens for metastatic disease are permitted for patients enrolled on the phase I portion of the trial; patients with HER2/neu positive breast cancer are not eligible; patients treated with prior anthracycline therapy as neoadjuvant, adjuvant, or metastatic therapy are not eligible unless the following conditions are met: (a) prior cumulative doxorubicin dose is =< 240 mg/m^2 (or epirubicin dose is =< 400 mg/m^2), and (b) left ventricular ejection fraction (LVEF) obtained at baseline is at least 50% (or >= 5% above lower institutional limits of normal whichever is higher); patients with estrogen receptor (ER)-positive disease are required to have relapse or progression on at least one line of endocrine therapy
Patients may have had prior adjuvant treatment for pancreatic cancer; the last dose of chemotherapy must have been > 4 months prior to study entry; patients with prior radiotherapy are acceptable; it must be at least 4 months since administration of radiation therapy and all signs of toxicity must have abated
Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
No prior chemotherapy for inoperable locally advanced or mUC. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
Patients who have received a total of at least 36 weeks of trastuzumab therapy (including neoadjuvant and adjuvant settings)
There is no restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting
Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
History of biopsy-proven HER2-overexpressing breast cancer and radiographic evidence of metastatic disease, or locally recurrent unresectable disease; the HER2 status can be determined either by immunohistochemistry (IHC) (IHC score, 3+) or by fluorescence in situ hybridization (FISH) (as defined by HER2/CEP-17 ratio >= 2.0, or HER2 copy number >= 6); patients must have received prior trastuzumab, independent of response to prior trastuzumab, and a taxane (in any disease setting, e.g. neo-adjuvant, adjuvant, metastatic)
Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
No prior chemotherapy for metastatic/recurrent disease; prior adjuvant or neo-adjuvant treatment with a fluoropyrimidine or fluoropyrimidine based regimen is allowed only if it is completed at least 6 months prior to the start of study drug, whether given alone or with radiation therapy; patients who have received prior neo-adjuvant therapy (chemotherapy and/or radiation therapy) which did not contain fluorouracil (5-FU) or capecitabine and have been diagnosed with metastatic disease (with no previous treatment in the metastatic setting) are eligible; no 6-month window is required for these patients; in the setting of metastatic disease requiring local palliation, only radiosensitizing doses of 5-FU or capecitabine monotherapy are permitted
Plans to undergo neo-adjuvant radiation and surgery with curative intent
Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis, who had obtained a best response of at least stable disease (SD) or a partial response (PR) for a period of 2 months with no further shrinkage of ? 20% on scan on their first line of chemotherapy for their advanced metastatic disease. Note: Patients that have had prior chemotherapy as adjuvant or neoadjuvant therapy are permitted.
Patients must be immunotherapy-naive. Those who have previously been treated with conventional chemotherapy for a prior history of sarcoma in the adjuvant setting may be included.
At least one prior line of systemic treatment; if the only prior line of treatment was adjuvant or neoadjuvant, patient must have completed treatment within 12 months; there is no limit to number of prior therapies
Subjects who have documented disease recurrence within 6 months of completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for study; subjects who recur greater than 6 months after completing adjuvant chemotherapy will not be eligible unless they receive additional chemotherapy for advanced disease
In dose escalation, patients must have had at least one prior line of chemotherapy for advanced disease or progressed within 6 months of adjuvant therapy (prior chemotherapy and/or anti-EGFR therapy is permitted)
Prior neoadjuvant or adjuvant systemic therapy or local intravesical chemotherapy or immunotherapy is permitted if such therapy was completed at least 12 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or stabilized or resolved
Has received prior chemotherapy for NSCLC with the exception of neoadjuvant or adjuvant platinum-based chemotherapy for NSCLC completed > 6 months prior to enrollment
The subject has demonstrated radiographic progression after front-line treatment for locally advanced or metastatic disease (prior adjuvant therapy allowed if >= 6 months elapsed between end of adjuvant therapy and metastatic relapse)
Patients who had prior carboplatin in the metastatic setting are not eligible\r\n* Note: Prior carboplatin as neoadjuvant or adjuvant treatment is permitted
Subjects must have progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic settings) for urothelial cancer
Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
Received one or more prior therapies for TNBC or inflammatory breast cancer in the metastatic setting, and prior treatment (metastatic or (neo) adjuvant) must have included a prior taxane and/or anthracycline-based therapy.
Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are not excluded.
Patients should be chemotherapy naive in the stage IV non-small cell lung cancer (NSCLC) setting, with the exception of chemotherapy for neoadjuvant or adjuvant treatment that completed at least 6 months before the study treatment
Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Prior chemotherapy:\r\n* Patients may have received 1-3 prior therapies for metastatic disease (note: for patients who have first developed recurrent/metastatic disease within 12 months of completing any (neo)-adjuvant therapy for triple-negative breast cancer, the (neo)-adjuvant therapy is counted as a prior line of therapy)\r\n* Patients must have been off treatment with myelosuppressive chemotherapy for at least 21 days or nonmyelosuppressive agents for 14 days before registration; patients should also be adequately recovered (to baseline or grade 1) from acute toxicities of prior treatment except for residual alopecia and peripheral neuropathy
Patients may have received adjuvant or neoadjuvant chemotherapy with or without trastuzumab and pertuzumab with an interval greater than 12 months since completion of adjuvant/neoadjuvant treatment
At eligibility recheck prior to vaccination, the above criteria must be met plus:\r\n* Completed adjuvant chemotherapy:\r\n** Initiation of adjuvant chemotherapy within 12 weeks of surgery\r\n** Completion of at least 4 months of adjuvant chemotherapy with gemcitabine/capecitabine or similar adjuvant chemotherapy at the discretion of the patient’s medical oncologist\r\n** Additional chemoradiation therapy as recommended by the patient’s medical oncologist\r\n** Reimaging within 4 weeks of last dose of chemotherapy demonstrates no evidence of recurrent disease and CA 19-9 is less than 92.5 u/mL\r\n** Dose modifications and/or delays in adjuvant chemotherapy is at the discretion of the treating physician\r\n* Neoadjuvant chemotherapy is exclusionary\r\n* There is a 1 week washout prior to day 1 of vaccine for patients on daily systemic steroids at doses exceeding 10 mg prednisone
Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration; most patients will undergo restaging midway through adjuvant chemotherapy and at the completion of therapy; however, timing of imaging is at the discretion of the patient’s medical oncologist
Any prior anti-vascular endothelial growth factor (VEGF) therapies (i.e., sunitinib, sorafenib, pazopanib, axitinib, cabozantinib, bevacizumab, etc.), including in the adjuvant or neoadjuvant setting
Must have radiographic disease progression after 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy
Prior chemotherapy, hormonal and radiation therapy administered in the adjuvant setting will be allowed
Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy; patients who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated; patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed in the study
Completion of neoadjuvant or adjuvant chemotherapy
Completion of adjuvant locoregional radiation, if indicated, is required prior to starting study treatment
At the time of study enrollment, patients must have at least 4 months of adjuvant trastuzumab planned
No prior line of systemic therapy for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ?3 months prior to enrollment and no lingering toxicities are present.
Prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred = or > 6 months after the last dose of the adjuvant or neoadjuvant therapy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry; all prior treatment-related toxicity must be resolved prior to study enrollment; concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines
Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration
Patients must have received standard of care therapy with chemoradiation with temozolomide followed by adjuvant chemotherapy with temozolomide. Patients may have received one additional chemotherapy regimen (other than lomustine) in addition to adjuvant temozolomide prior to study entry (patients at either first or second recurrence are eligible).
Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
Patients must have a histologically confirmed solid tumor that is surgically resected and have completed all planned adjuvant therapy or are not planned for any adjuvant therapy (including hormonal); patients must have fully recovered from surgery (i.e. sutures and drains have been removed); patients must have recovered from toxicity of prior chemotherapy and/or radiotherapy; patients may not have received chemotherapy in the prior four weeks; patients may have not received radiotherapy in the prior three weeks
Patients must have received at least one prior line of therapy for the treatment of metastatic disease with a fluoropyrimidine in combination with oxaliplatin and/or irinotecan; patients with prior adjuvant therapy who progressed within 6 months of completion of treatment may be eligible
Must have received at least 1 prior systemic therapy for advanced disease (does not include adjuvant/neoadjuvant therapy in a curative setting)
Previous disease progression on or intolerance to one line of therapy – either platinum-based or immunotherapy (pembrolizumab or nivolumab); prior chemotherapy in the induction, organ preservation, definitive or adjuvant setting permitted if it was for initial treatment of locally advanced or metastatic disease and completed more than 4 months prior to enrollment on the current study; 2-week washout period prior to treatment start will be required
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until study entry.
Prior therapies:\r\n* Patients must have previously received an aromatase inhibitor in the adjuvant, neo-adjuvant or metastatic setting\r\n* The minimum duration of aromatase inhibitor (AI) in the adjuvant setting is 2 years\r\n* There is no minimum duration of AI in the metastatic setting or neoadjuvant setting\r\n* Patients may have been previously treated with a CDK 4/6 inhibitor or mTOR inhibitor or other investigational agent in addition to an aromatase inhibitor\r\n* Prior treatment with tamoxifen is allowed in the adjuvant setting provided that it was followed by a minimum of 2 years of an AI
Patients must be in consideration for 1st line systemic therapy for recurrent IBC; NOTE: Patients must not have received chemotherapy in the metastatic setting, but adjuvant treatment after surgery is acceptable
Patients who received adjuvant or neoadjuvant chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above
Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
At least 1 prior systemic therapy for metastatic disease; adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless patients progressed within 6 months of completion of chemotherapy
History of another primary cancer diagnosis, treated with adjuvant chemotherapy
Patients must satisfy the following criteria for prior therapy:\r\n* Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment; palbociclib and AI must be the most recently received treatment prior to enrollment; up to one (1) prior line of chemotherapy for advanced/metastatic disease is allowed in addition to any number of prior lines of endocrine therapy\r\n* No prior treatment with fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway in the metastatic setting; use of these agents in the neoadjuvant and/or adjuvant settings is permitted\r\n* Patients receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Patients must have been previously treated for GBM with radiation with concurrent and adjuvant temozolomide chemotherapy.
INCLUSION CRITERIA FOR TNBC: Patients must have received standard adjuvant, neoadjuvant, and/or metastatic chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional practice; no maximum on number of prior systemic treatment regimens
Failed at least one line of chemotherapy; neoadjuvant and adjuvant chemotherapy count as a prior line of therapy
Randomized phase II: be treatment naive in the stage IV setting; subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease < 6 months of completing therapy are ineligible for this arm; subjects with recurrent disease >= 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, are eligible for this arm
Patients who received adjuvant chemotherapy plus or minus radiation and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are NOT eligible; if patients received adjuvant treatment and had disease recurrence after 6 months, patients will be eligible
Prior adjuvant chemotherapy with gemcitabine and/or docetaxel/paclitaxel is allowed
Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team)
Prior chemotherapy in the adjuvant setting is allowed
Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
Must have received at least one but no more than 3 lines of chemotherapy for advanced breast cancer\r\n* Patients who have developed metastatic disease on adjuvant hormone therapy within 24 months of completing adjuvant chemotherapy are considered to have had one line of chemotherapy and are eligible for this trial
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier\r\n* For Part I, prior adjuvant therapy with gemcitabine or a fluoropyrimidine therapy is permitted if completed > 6 months prior to recurrence; no prior PARP inhibitor therapy is allowed\r\n* For Part II, no prior PARP inhibitor therapy is permitted; up to two prior treatment regimens are permitted as follows: 1 adjuvant and 1 metastatic; 1 locally advanced and 1 metastatic; or 2 metastatic, or a variation thereof
Any neoadjuvant or adjuvant chemotherapy regimen is permitted; prior chemotherapy for the treatment of this breast cancer is not required
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
ARM A COHORT 1: Patients must not have received prior therapy for metastatic or advanced disease; adjuvant therapy that is gemcitabine based is allowed as long as the adjuvant treatment was completed >= 6 months before the diagnosis of recurrent disease
Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment
Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
Previously treated with no more than two lines of prior systemic therapy for advanced stage lung cancer\r\n* Patients who previously received neoadjuvant, concurrent, or adjuvant chemotherapy for localized NSCLC and then recurred within 6 months of completing chemotherapy may be considered as having received one line of prior therapy\r\n* Maintenance therapy does not count as a separate line of therapy
No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible. Radiation: • Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.
Patient has prior history of intolerance to adjuvant interferon-alpha therapy
Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy; subjects will be excluded if this is their first relapse and they have recurred > 6 months from completion of primary (adjuvant) chemotherapy
No plan to treat with adjuvant hormonal or radiation therapy
Patients with T3b, or T4, or node positive disease will be excluded as they will be considered for adjuvant hormone therapy
Up to 2 prior cytotoxic chemotreatment regimens in the metastatic setting are allowed; adjuvant chemotreatment will not be considered a prior line of treatment
Prior trastuzumab use in the adjuvant or metastatic setting
Either:\r\n* Patients who have received radiation therapy (RT): Previously (>= 6 months before to enrollment) completed treatment for pancreatic or periampullary adenocarcinoma consisting of either surgical resection with neoadjuvant/adjuvant conventional conformal radiation therapy (CRT) for resectable disease or conventional CRT as definitive treatment for unresectable disease; these patients who have received prior radiation therapy will constitute Cohort A and will receive SBRT as 5 Gy x 5; patients may be receiving continued chemotherapy post initial CRT; OR\r\n* Patients who have not received RT: Previously (>= 3 months before retreatment) initiated treatment for pancreatic or periampullary adenocarcinoma consisting of chemotherapy alone for unresectable disease or surgical resection with neoadjuvant/adjuvant chemotherapy for resectable disease; these patients who have not received prior radiation therapy will constitute Cohort B and will receive SBRT as 6.6 Gy x 5; patients must have attempted chemotherapy upon initial diagnosis
Patients must have received at least one, but not more than three, systemic regimens for treatment of metastatic soft tissue sarcoma; patients must have had a prior anthracycline in either the adjuvant or metastatic setting unless medically inappropriate for the patient
Adjuvant therapy will not count towards prior treatment for metastatic disease, unless the patient relapsed within 1 year of completing adjuvant therapy
Regarding prior malignancies:\r\n* Patients with a second active malignancy being actively treated at the time of screening with palliative or curative intent with cytotoxic chemotherapy, surgery, or radiation are ineligible\r\n* Patients with stage III or stage IV cancers of any type who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting within 3 years of screening are ineligible  \r\n** For these patients, if more than three years have passed from the completion of adjuvant therapy to screening for the current protocol, then the patient is eligible for enrollment\r\n* However, patients with stage I or stage II cancers of any type, and who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting by the time they are screening for the current protocol are eligible for enrollment\r\n* Patients who are being treated with adjuvant hormonal therapies, such as anti-estrogens or anti androgens, are eligible for enrollment provided they stop the hormonal therapy prior to starting the study medications\r\n* Finally, patients with cervical cancer in situ, in situ carcinoma of the bladder, or non-melanoma carcinoma of the skin that have been removed, are eligible for enrollment at any time\r\n* Questions regarding the inclusion of individual subjects should be directed to the principle investigator
No prior first line systemic treatment (prior adjuvant or neoadjuvant treatment is permitted); subjects whose disease has progressed after 6 months of last systemic chemotherapy or chemo-radiation in the adjuvant or neoadjuvant setting are eligible
Have been a participant in Hopkins Institutional Review Board (IRB) protocol (J0810) application number 00-01-58-58 entitled \A randomized three-arm neoadjuvant and adjuvant feasibility and toxicity study of a GM-CSF secreting allogeneic pancreatic cancer vaccine administered either alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas\ (the J0810 cohort), or IRB protocol (J1568) application number 00-05-05-17 entitled “A Randomized Study of a GM-CSF secreting allogeneic pancreatic cancer vaccine with or without a PD-1 Blockade Antibody (Nivolumab) for the Neoadjuvant and Adjuvant Treatment of Patients with Surgically Resectable Adenocarcinoma of the Pancreas” (the 1568 cohort) or have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation (the vaccine-naive cohort)
Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease
Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment.
Have had no prior systemic chemotherapy for metastatic disease; at least 6 months since prior adjuvant chemotherapy. Additional Inclusion Criteria for Cohort 2:
Prior chemotherapy, adjuvant therapy, or radiotherapy for gastric cancer
Patients must have received at least one prior chemotherapy regimen for metastatic disease\r\n* NOTE: Patients who received anthracycline and taxane containing adjuvant or neoadjuvant therapy and progressed within 12 months may enter this trial as their first therapy for metastatic breast cancer (MBC)
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
Patients undergoing neo-adjuvant systemic therapy.
Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Patients may not have received prior systemic chemotherapy for metastatic/advanced urothelial carcinoma; note: prior neoadjuvant/adjuvant therapy is permitted if completed >= 12 months prior to registration for protocol therapy; prior intravesical therapy is permitted
Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
Naïve patient or patient previously treated with imatinib as neoadjuvant/adjuvant who relapsed after imatinib discontinuation
Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
Must be naive to systemic treatment for NSCLC. Patients who received adjuvant or neo-adjuvant chemotherapy are eligible if at least 6 months have passed since last treatment.
Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.]
Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor
Prior therapy with a MEK-inhibitor or docetaxel for metastatic non-small cell lung cancer (docetaxel in the adjuvant setting will be allowed)
Must have completed 3 cycles of neo-adjuvant chemotherapy. Either capecitabine-oxaliplatin (CAPEOX) or leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) is allowed. Dose modifications are allowed, but all 3 cycles must have been completed.
Must be deemed as a good candidate for adjuvant chemotherapy or chemoradiation (to start within 3 months of surgery), in the opinion of the treating investigator. Plan must be to start adjuvant therapy within 90 days of surgery; adjuvant treatment cannot begin more than 90 days after surgery.
More than one prior taxane regimen at any stage of the disease under study (“taxane” refers to paclitaxel, docetaxel, abraxane and cabazitaxel); adjuvant and/or neoadjuvant treatments are considered together as one prior regimen
Prior adjuvant chemotherapy is allowed, as long as a minimum of 3 months (for pancreatic cancer) and 6 months (for colorectal cancer) has passed between the completion of adjuvant therapy and the start of first line therapy
Cholangiocarcinoma cohort specific criteria:\r\n* Patients must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible\r\n* Patients must have failed at least one (but no more than 2) prior line of systemic therapy in the advanced disease setting\r\n* Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; in this case, the adjuvant therapy will count as the minimum required one prior line of therapy; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence\r\n* If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be =< 2.5 x IULN; stability is defined as the second measurement being no more than one point higher than the first
Adjuvant systemic treatment for colorectal cancer within last 12 months
Prior treatment may include a taxane as per the following criteria:\r\n* Prior taxane (including paclitaxel) in the adjuvant or neoadjuvant setting is allowed, provided that the interval between the completion of (neo)adjuvant therapy and disease recurrence is > 12 months\r\n* Prior taxane in the metastatic setting is allowed, provided that the agent administered in the metastatic setting was not standard paclitaxel
Prior chemotherapy or immunotherapy for metastatic urothelial cancer; prior neoadjuvant or adjuvant chemotherapy with first progression > 12 months is allowed; prior intravesical treatments such as Bacillus Calmette-Guerin (BCG) are allowed, however no BCG is allowed within 4 weeks prior to initiation of study treatment
No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Completed last cycle of chemotherapy (which can be given in the adjuvant and/or neoadjuvant setting) >= 60 days but not >= 365 days prior to randomization
Had at least one prior line of systemic chemotherapy for metastatic disease; adjuvant therapy would not count toward first-line therapy unless patient recurs less than 6 months after completion of that regimen
For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted; for patients with metastatic disease, prior treatment for non-metastatic disease with 5-fluorouracil (5-FU) or gemcitabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no >= grade 2 treatment-related toxicities are present
Eligible for and willing to undergo a course of adjuvant endocrine therapy
Prior therapy: Eligible subjects must have had 1 line of systemic cytotoxic treatment; this may be adjuvant therapy with documented progression within 12 months of completion, or 1 line of cytotoxic therapy for metastatic disease; NOTE: eligible patients are allowed up to 2 lines of systemic cytotoxic treatment, of which only 1 line is allowed for metastatic disease; the acceptance of progression within 12 months of adjuvant is part inclusion to not require patient to re-challenge with chemotherapy (chemo) if they progressed soon after adjuvant therapy; prior hormonal therapy for metastatic/recurrent disease is also allowed; prior targeted therapy not directed against cMET or vascular endothelial growth factor (VEGF) pathways is allowed
Patients must have received at least one prior line of chemotherapy, for ULMS (either in the adjuvant or metastatic setting)
Prior therapy:\r\n* At least 1 prior chemotherapy regimen for treatment of metastatic breast cancer, and/or\r\n* Recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy, and/or\r\n* For patients with inflammatory breast cancer but no distant metastases, progression through standard (anthracycline- and taxane-based) neoadjuvant chemotherapy is required
Subject has had prior progression on treatment with fulvestrant (prior adjuvant treatment or brief exposure in the advanced setting is allowed)
Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior\n             neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial\r\n* NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy
Prior treatment with cytotoxic chemotherapy is not a requirement, but allowed only if used in neoadjuvant, adjuvant or for bladder preserving protocols, as long as was administered > 6 months prior to starting study
Prior treatment with any cytotoxic chemotherapy in metastatic setting; prior treatment with cytotoxic chemotherapy is allowed only if used in neoadjuvant, adjuvant or for bladder preserving protocols, as long as was administered > 6 months prior to starting study
PRE-MENOPAUSAL ELIGIBILITY: \r\n* Premenopausal women who received adjuvant aromatase inhibitor and ovarian suppression (AI + OS) in the adjuvant setting and completed at least 12 months of hormonal therapy\r\n* Pre-menopausal women with de novo metastatic disease are eligible if they have had no prior endocrine therapy\r\n* Premenopausal women who have not received tamoxifen in the metastatic setting, but have received up to two lines of chemotherapy
POSTMENOPAUSAL ELIGIBILITY: \r\n* Postmenopausal women who have progressed on first-line or second line therapy with an aromatase inhibitor in the metastatic setting\r\n* Postmenopausal women who have recurred while on or after completion of adjuvant treatment with aromatase inhibitors (they have completed at least one year of AI in the adjuvant setting before progression on AI)\r\n* Postmenopausal women who are not considered candidates for treatment with an aromatase inhibitory by their oncologist, patients not willing to go on AI, or patients who were intolerant to AI\r\n* Postmenopausal women are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase; for the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable
Patient has received tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on tamoxifen in the adjuvant setting
All patients should have received at least one line of chemotherapy in either the advanced or adjuvant setting and hormonal therapy (where appropriate)
Previous neo-adjuvant or adjuvant treatment is allowed provided that it was given >= 6 months prior to registration
PHASE II: Previous neo-adjuvant or adjuvant treatment is allowed provided that there was no evidence of recurrent disease for at least 6 months after completion of neo-adjuvant/adjuvant treatment
Study participants must have completed any prior treatment at least 3 weeks prior to treatment on this protocol; prior treatments may have included chemotherapy however may not have included BRAF or MEK inhibitors or immunotherapies (interleukin-2, ipilimumab, anti-programmed death [PD]1 antibodies etc.) excluding vaccine therapy; prior treatment with interferon in the adjuvant setting is allowed, though prior treatment with ipilimumab in the adjuvant setting is not; prior radiation therapy is allowed though must have included no more than 3000 centigray (cGy) to fields including substantial marrow
Must have received trastuzumab (neoadjuvant, adjuvant or metastatic setting)
No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy
Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
No prior neoadjuvant/adjuvant therapy for DCIS diagnosis
Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
Has received prior systemic therapy for Stage IV colorectal cancer. May have received prior adjuvant chemotherapy for colorectal cancer as long as it was completed at least 6 months prior to randomization on this study
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.
Subjects who received prior adjuvant therapy for melanoma will not be excluded (including, but not limited to, interferon, ipilimumab, limb infusion/perfusion, or use of investigational agents in the adjuvant setting) with the exception that prior adjuvant therapy with inhibitors of programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) is not allowed. However, if the subject received adjuvant therapy, the subject must have completed therapy at least 28 days prior to enrollment.
Any prior chemotherapy; the only exception will be patients with a history of stage I seminoma treated with adjuvant carboplatin for 1 of 2 cycles
Approved adjuvant therapies, which may include molecularly-targeted agents, IFN ?, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have a 6 month washout before receiving any dosing on this study
Patients may have received prior androgen deprivation therapy (ADT) - neoadjuvant and/or adjuvant setting only, but it must not have lasted for more than 36 months (note that this is NOT the same as “late induction” as described in Section 5.1b above); single or combination therapy allowed; at least 6 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting, and serum testosterone must be > 50 ng/dL (non-castrate levels) within 28 days prior to registration for early induction patients; Note: serum testosterone assessment is required for eligibility for only those with prior treatment with ADT
Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; at least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting
Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
At least 3 weeks (21 days) must have passed since the completion of adjuvant chemotherapy or radiotherapy
Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ? 4 cycles or ? 12 weeks which included taxanes prior to screening
Patient has completed adjuvant radiotherapy (if indicated) prior to screening
Previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participant may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization
Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.
Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2
Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration
Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.
Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
Patient must not have received any prior or concurrent systemic therapy for RCC; adjuvant placebo administration is permitted
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
Have received prior systemic taxane therapy for transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic).
nab-Paclitaxel + Nivolumab and nab-paclitaxel, Gemcitabine and Nivolumab: Subjects must have received no previous systemic chemotherapy or investigational therapy for the treatment of pancreatic adenocarcinoma, including neo-adjuvant or adjuvant therapy, with the exception of prior treatment administered as a radiosensitizer concomitant with radiotherapy in the adjuvant setting. In this case, ? 6 months must have elapsed since completion of the last dose and no lingering toxicities may be present. Initial diagnosis of metastatic disease must have occurred ? 6 weeks prior to randomization in the study.
Subjects must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Adjuvant, neo-adjuvant chemotherapy or chemoradiotherapy is permitted providing cytotoxic chemotherapy was completed > 12 months prior to randomization, without disease recurrence or progression during those 12 months.
If subject has received solvent-based paclitaxel (TAXOL) or docetaxel as adjuvant chemotherapy, subject must not have relapsed with breast cancer within 12 months of completing said therapy.
Patients must have completed a course of prior adjuvant trastuzumab or experienced side effects that resulted in early discontinuation of trastuzumab that have since resolved
All patients should have received at least one line of chemotherapy in either the advanced or neo/adjuvant setting and hormonal therapy (where appropriate); participants who have previously been treated with endocrine therapy only, and later develop triple negative disease are eligible as long as they have had one line of chemotherapy in either the advanced or neo/adjuvant setting
Prior systemic therapy for this type of sarcoma; neoadjuvant or adjuvant therapy more than two years prior would not apply
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Participants may have received 0-1 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to registration; no prior platinum in the metastatic setting is allowed; prior platinum in the neo/adjuvant setting is permissible, if at least 12 months elapsed since the end of adjuvant therapy to the development of metastatic disease; all toxicities related to prior chemotherapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grade 1 or lower; if a patient recurs within 12 months of neoadjuvant or adjuvant chemotherapy, this will be counted as one line of therapy for metastatic disease
Has received no prior systemic therapy for advanced RCC. Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed >12 months prior to allocation.
No more than one prior line of systemic treatment for glioblastoma. Concurrent and adjuvant TMZ-based chemotherapy, including the combination of TMZ with an investigational agent, is considered one line of therapy.
Prior neoadjuvant, adjuvant, or palliative chemotherapy for ATC is allowed.
Histologically confirmed GBM at first or second recurrence after concurrent or adjuvant chemotherapy or radiotherapy (must have received temozolomide).
Women must have received ? 1 prior hormonal treatment(s) in the metastatic or adjuvant setting. If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be ? 6 months. If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be ? 3 years
Have received a second line chemotherapy after progressing on or not tolerating treatment with FOLFIRINOX as a first line. Prior adjuvant/neoadjuvant gemcitabine or gemcitabine-based radiation will not be counted as first line therapy.
Have received Gemcitabine for palliative treatment or progressed while receiving it or is within 3 months of completion in the adjuvant setting.
For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
Completed primary treatment (surgery and radio/chemotherapy in adjuvant and/or neo-adjuvant setting) <360 days prior to first vaccination.
Prior treatment\r\n* No more than two prior chemotherapy regimens in the metastatic setting\r\n* Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required\r\n* Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus or cyclin dependent kinase (CDK) 4/6 inhibitor (such as palbociclib, abemaciclib or ribociclib) containing regimen\r\n* Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within 1 year of stopping tamoxifen\r\n* No prior treatment with tamoxifen in the metastatic setting\r\n* No prior treatment with endoxifen\r\n* Patients who have not fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment are not eligible to participate in this study\r\n** EXCEPTION: neuropathies-if grade 2 neuropathies have been stable for at least 3 months since completion of prior treatment patient is eligible
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
For Part B - Subjects must not have received any prior systemic treatment for metastatic MCC. Prior chemotherapy treatment in the adjuvant setting (no clinically detectable disease; no metastatic disease) is allowable if the end of treatment occurred at least 6 months prior to study start)
Patients must have had prior treatment with anthracyclines and/or taxanes (resistant) or platinum including adjuvant or neoadjuvant therapy
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If ? 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence the therapy will not be considered a line of therapy in the locally recurrent or metastatic TNBC setting.
The interval between completion of standard adjuvant chemotherapy and randomization must be less than or equal to 60 days.
Patients who received Gemcitabine-based therapy in an adjuvant setting will be allowed to be enrolled on Arm A of the trial (Gemcitabine with nab-Paclitaxel) as long as their last Gemcitabine administration was at least 6 months prior to the first dose of BBI608.
Recurrence while on, or within 12 months of end of adjuvant treatment with letrozole or anastrozole, or
Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
Previous adjuvant endocrine therapy for initial breast cancer was allowed but had to be discontinued at least 1 week before receiving the study drug
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
Received a radiosensitizer or any additional adjuvant therapy during radiation therapy.
Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)
Any prior androgen-deprivation therapy or finasteride as neoadjuvant or adjuvant therapy or for biochemical recurrence must have been discontinued at least 6 months prior to registration.
Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
Must have started adjuvant FOLFOX chemotherapy within 8 weeks of resection for colorectal carcinoma
relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor) for advanced/metastatic disease
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Has received reradiation to recurrent disease (other than standard frontline adjuvant radiation therapy)
Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
Received at least one prior pemetrexed-based chemotherapy for unresectable disease, unless within 3 months of receiving platinum-pemetrexed therapy for neoadjuvant or adjuvant treatment that has been unsuccessful
Patients who received (neo) adjuvant therapy for breast cancer are eligible
Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment\r\n* There is no limit to the number of prior lines of treatment a patient has received\r\n* No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less
Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ?12 months from completion of treatment
Patients must have had one or two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease; (a maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment); prior treatment with irinotecan is allowed; prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
Prior Therapy:\r\n* No more than two regimens in the metastatic setting as long as patients have adequate performance status; patients with no prior chemotherapy for metastatic disease may be included in the trial if they received anthracyclines and taxanes in the adjuvant or neoadjuvant settings; chemotherapy naïve patients with metastatic disease must have failed anthracyclines and taxanes\r\n* Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry\r\n* Patients must have completed radiation therapy at least 21 days prior to beginning protocol treatment
No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting
Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ? 12 months from completion of treatment until randomization.
Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.
Prior therapy with interferon alfa (in neoadjuvant, adjuvant, or metastatic settings) (Part 1A only)
Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy that included a taxane and/or anthracycline, if not contraindicated.
Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a. Hormone receptor positive patients must also have hormone resistant disease (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ? 12-months from completion of treatment.
Either treatment naïve or received only one line of systemic anticancer therapy if v-raf murine sarcoma viral oncogene homolog B1 (BRAF) wild-type or up to two lines of systemic anticancer therapy including one BRAF inhibitor-containing regimen if BRAF mutant. Treatments given in an adjuvant setting (eg, interferon, radiotherapy, isolated limb perfusion, or investigational agents) are not considered as prior lines of therapy. No prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines are allowed, even if given in the adjuvant setting.
A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy)
Patients must have undergone prior standard therapy of radiation therapy, and adjuvant chemotherapy
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization
Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization
Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ? 2 weeks prior to randomization
Prior chemotherapy or immunotherapy for metastatic urothelial bladder cancer; prior neoadjuvant or adjuvant chemotherapy with first progression > 12 months is allowed
Disease that progressed during treatment or within 12 months of completion of adjuvant therapy with tamoxifen and/or an aromatase inhibitor (AI).
Received non-oncology vaccine therapy for prevention of infectious diseases during the 4-week period prior to first dose of nivolumab therapy. Patients may not receive any non-oncology vaccine therapy during the period of NEO-PV-01 + adjuvant or nivolumab administration and until at least 8 weeks after the last dose of the booster vaccine. Annual influenza vaccines are allowed during screening and pre-treatment but not during nivolumab or NEO-PV-01 + adjuvant dosing.
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and at least six months earlier); prior topical fluoropyrimidine use is allowed
Patients must have had one prior systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix (e.g.; paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab), at least one which must have contained bevacizumab\r\n* NOTE: Patients are allowed to receive 1-2 prior regimens for management of recurrent, persistent or metastatic carcinoma of the cervix; patients who have received more than two prior systemic regimens for management of recurrent, persistent or metastatic carcinoma of the cervix are NOT eligible\r\n* NOTE: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy (e.g., paclitaxel and carboplatin for up to 4 cycles)
No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed)
Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted therapies), and at least one regimen must have been platinum-based; immunotherapy will not be counted as a prior regimen; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) >= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered
Any prior systemic or investigational therapy for metastatic pancreatic cancer; systemic therapy administered alone or in combination with radiation in the adjuvant or neoadjuvant setting is permissible as long as it was completed > 6 months prior to the time of study registration
Patients who have been previously treated in the adjuvant setting for melanoma will be eligible for treatment after a 28 day wash-out period
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
No more than two prior lines of chemotherapy for metastatic sarcoma are allowed; neoadjuvant/adjuvant chemotherapy with definitive therapy (radiation, surgery or radiation and surgery) will not be counted as one of these prior lines of therapy; non-cytotoxic therapies will not be counted as one of these prior lines of therapy
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.
The participant has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
May not have received prior chemotherapy; if patient has received prior adjuvant therapy, must be > 6 months from treatment
ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed)
Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents).
Patient has had prior systemic therapy for MCC\r\n* Note: prior systemic cytotoxic chemotherapy will be allowed if it was administered in the adjuvant setting (no clinically detectable MCC at the time) and treatment concluded more than 6 months prior to beginning study treatment
Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
Prior treatment with trastuzumab + pertuzumab (HP)-based or pertuzumab-based therapy in the neoadjuvant/adjuvant, unresectable, locally advanced, or metastatic setting
Patients are allowed to have had a maximum of 1 prior chemotherapy regimen for metastatic disease; patients are allowed to have a maximum of two prior regimens if they previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for their initial localized disease
One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Prior therapies:\r\n* All women: at least one prior line of hormonal therapy for de novo disease (stage IV metastatic at diagnosis, no prior adjuvant therapy) or relapse > 1 year after completion of adjuvant therapy; relapse on adjuvant hormonal therapy will count as the one prior line of therapy\r\n* All women: at least 1 prior line of chemotherapy in the adjuvant and/or metastatic setting, but not more than 2 regimens in the metastatic setting
Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted
Prior treatment in the adjuvant or metastatic setting with any of the following:\r\n* Agents disrupting VEGF activity or targeting vascular endothelial growth factor receptor (VEGFR);\r\n* Ipilimumab;\r\n* Or taxane based chemotherapy regimens (including paclitaxel, docetaxel, cabazitaxel or nab-paclitaxel)
• Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
Patients must have failed no more than 2 prior line of systemic chemotherapy for advanced biliary cancer; patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one line of systemic chemotherapy used to treat the disease recurrence
Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.
relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor
Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Patients previously treated with chemotherapy for mCRPC; at least 12 months must have elapsed from chemotherapy given in the adjuvant or neo-adjuvant setting
Subjects in the dose-escalation component can have had up to 1 prior line of systemic therapy. Subjects with pancreatic carcinoma to be enrolled in the MTD expansion cohort must have untreated, measurable metastatic disease. Subjects for the MTD cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than 6 months has elapsed following completion of adjuvant therapy.
Planning to initiate adjuvant or neoadjuvant anthracycline (AC) chemotherapy (doxorubicin [doxorubicin hydrochloride] 60 mg/m^2 and cyclophosphamide 600 mg/m^2 every 2-3 weeks x 4 cycles)\r\n* Note: \r\n** Participants may be planning to receive additional adjuvant therapy after the completion of AC chemotherapy\r\n** Receipt of all standard chemotherapy and/or targeted therapy regimens after AC that deemed clinically appropriate by the treating physician are permitted; for example, patients may receive taxanes or carboplatin/paclitaxel; Her2 positive patients may receive trastuzumab with or without pertuzumab\r\n** HER2 positive patients must be planning to initiate trastuzumab therapy after AC chemotherapy
Progression after neoadjuvant or adjuvant platinum based chemotherapy if the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months since the last administration of such therapy.
Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy, for non-metastatic disease but it must not have lasted for more than 36 months; at least 12 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting
Patients with a history of prior neoadjuvant/adjuvant hormone therapy are eligible provided they have received twenty four or less months of hormone treatment (single or combination treatment, excluding orchiectomy); neoadjuvant/adjuvant hormone therapy must have been discontinued at least 6 months prior to registration; this is intended to exclude patients who might have been rendered indirectly androgen insensitive
Patients with breast cancer may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for metastatic or locally recurrent disease; subjects with ovarian cancer may have had two regimens for advanced or persistent disease
Participants may or may not have received (neo) adjuvant chemotherapy, but must be at least 30 days after last dose of chemotherapy and/or biologic therapy, with no more than grade 1 residual toxicity at the time of screening
Patients must have had progression on a trastuzumab and/or taxane-based chemotherapy regimen: \r\n* Metastatic patients must have progressed during or after trastuzumab and/or taxane treatment (at any time)\r\n* Locally advanced patients must have progressed within 6 months after trastuzumab and/or taxane treatment \r\nNote: patients who had prior trastuzumab and/or taxane-based chemotherapy in the adjuvant setting only may still be eligible if, in the opinion of the treating investigator, the patient is not an appropriate candidate to receive trastuzumab/pertuzumab/docetaxel as a first-line regimen for their metastatic disease
COHORT B: Prior radiotherapy to the prostate (adjuvant or salvage radiotherapy) is allowed
Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer
Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Prior treatment with trastuzumab and/or lapatinib or trastuzumab and pertuzumab in the neo-adjuvant or adjuvant setting is allowed but not required\r\n* Lapatininb has to be discontinued > 21 days before the initiation of the T+P study treatments; prior lapatinib in combination with hormonal therapy for treatment of MBC is allowed but not required as long as the other eligibility criteria are met
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
Unless either drug is medically contraindicated, patients must have received oxaliplatin and irinotecan as part of standard chemotherapy regimens. (This includes adjuvant therapy.)
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization.
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Participants who received preoperative therapy as part of a clinical trial may enroll. Participants may not have received adjuvant chemotherapy after surgery prior to randomization. Bisphosphonate use is allowed.
Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer
Participants must have received prior therapy with the following agents in any combination, and in setting (i.e., neoadjuvant, adjuvant, metastatic, etc.); these therapies do not need to be the most recent line of therapy\r\n* Trastuzumab\r\n* Pertuzumab\r\n* Ado-trastuzumab emtansine (T-DM1)
Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
Any number of prior chemotherapy regimens; up to two prior chemotherapy regimens in the palliative setting will be allowed in the expansion cohort; prior gemcitabine-based regimens in the palliative setting are permitted if no evidence of progression on therapy or at least 6 months after discontinuation of gemcitabine-based treatment; prior gemcitabine in the adjuvant setting is permitted if last treatment was greater than 6 months prior to registration
Participants must have received at least 1 line of chemotherapy for advanced or metastatic breast cancer and/or relapse/progressed while on or within 6 months of completion of neoadjuvant or adjuvant trastuzumab/pertuzumab; prior pertuzumab is allowed for Cohort B but not Cohort A
Participants must have had prior trastuzumab therapy (either in the adjuvant or metastatic setting)
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 number of prior endocrine therapies (including tamoxifen, fulvestrant and/or aromatase inhibitors in either the adjuvant or metastatic setting) and any number of prior chemotherapy regiments; anti-cancer systemic therapy, such as chemotherapy or biologics or endocrine therapy, other than the AI, must be discontinued for >= 3 weeks prior to starting study treatment
Active second cancer other than specified; active cancer refers to cancer that requires systemic chemotherapy or biological therapy within 6 months of the study entry; patients who have received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 6 months may participate in this study
Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.
Any previous chemotherapy, biologic therapy, or investigational agent, except for adjuvant therapy or as radio-sensitizing agents limited to 5-fluorouracil/capecitabine and gemcitabine; patient must have completed adjuvant therapy no less than six months prior to accrual
Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable
Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable stage III or stage IV disease; prior ipilimumab in metastatic setting is not allowed; prior therapy may include one line of targeted therapy for metastatic disease i.e. v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase kinase (MEK) inhibitor; at least 3 weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment; prior adjuvant interferon is permitted; prior cytotoxic therapy in adjuvant or metastatic setting is not allowed; prior ipilimumab in adjuvant setting is not allowed; prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed; prior palliative radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity
Any number of prior endocrine therapies in the metastatic setting are allowed. The patient must not have received any prior chemotherapy agents in the metastatic setting. Prior treatment with adjuvant docetaxel or paclitaxel is allowed if disease relapse occurred greater than 12 months from the completion of adjuvant therapy.
Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (>) 6 months prior to randomization and the Screening serum testosterone level is greater than or equal to (?)150 ng/dL
PRE-REGISTRATION INCLUSION CRITERIA: Planning to receive best practice adjuvant or neoadjuvant chemotherapy according to institutional guidelines; adjuvant tamoxifen or aromatase inhibitors treatment will be allowed for hormone receptor-positive patients; patients who have failed neoadjuvant endocrine therapy will also be eligible
Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy and/or ? 2 prior chemotherapy regimens (such as neoadjuvant/adjuvant treatment), however only 1 chemotherapy regimen in the metastatic setting is allowed.
Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic setting; post-operative adjuvant therapy for previously resected NSCLC is allowed as long as the last dose was given greater than 1 year before study entry, and there is current evidence of disease progression
Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
A minimum of 1 and a maximum of 3 prior chemotherapy regimens, including adjuvant and neo-adjuvant therapy for the treatment of sarcoma; patients eligible for an anthracycline should have received a prior anthracycline containing regimen; patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment
Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier); prior topical fluoropyrimidine use is allowed; prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil (fluorouracil) or known dihydropyrimidine dehydrogenase (DPD) deficiency
Endocrine resistant breast cancer, defined as either:\r\n* Relapsed while on adjuvant endocrine therapy or within 1 year of completion of adjuvant endocrine therapy or\r\n* Progression through at least one line of endocrine therapy for metastatic or locally advanced breast cancer; there is no limit on the number of prior endocrine therapies received
No prior systemic treatment for advanced or metastatic colorectal cancer is allowed; prior regional chemotherapy (e.g., hepatic arterial infusion) is also not allowed; patients may have received previous neoadjuvant or adjuvant chemotherapy and/or chemoradiation per institutional standard of care; the last course of adjuvant therapy must have been concluded > 12 months prior to colorectal cancer recurrence
Prior chemotherapy, other systemic therapy, or any investigational agent for treatment of advanced or metastatic colorectal cancer; patients who completed adjuvant or neoadjuvant chemotherapy > 12 months prior to colorectal cancer recurrence are eligible
Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier); prior topical fluoropyrimidine use is allowed; prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase (DPD) deficiency
Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
Subjects must have previously untreated locally advanced or metastatic pancreatic adenocarcinoma; patients newly diagnosed with metastatic recurrence after history of adjuvant therapy for resected disease are eligible, if completion of adjuvant therapy was greater than 8 months ago
One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ? 6 months after the last dose of the adjuvant or neoadjuvant therapy
Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
Patients with a histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract and hepatobiliary system, including patients with any of the following diagnoses and settings who are candidates to receive radiation with concurrent continuous infusion 5-FU or oral capecitabine chemotherapy:\r\n * Pancreatic adenocarcinoma (unresected or adjuvant)\r\n * Duodenal adenocarcinoma (unresected or adjuvant)\r\n * Extra-hepatic cholangiocarcinoma (unresected or adjuvant)\r\n * Gastric adenocarcinoma (unresected or adjuvant)\r\n * Gastroesophageal junction adenocarcinoma (adjuvant)
Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
Documentation of positive diagnosis for any of the following:\r\n* Non metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radio/chemotherapy \r\n*Stage II or III colorectal adenocarcinoma following appropriate surgery and adjuvant chemotherapy or following appropriate neoadjuvant chemoradiation/surgery and adjuvant chemotherapy\r\n* Stage II bladder carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant chemotherapy; patients with recurrent tumors are not eligible\r\n** “Appropriate therapy” for each disease must be consistent with the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
Previous immunotherapy treatment for metastatic disease in the preceding 2 months; Note: immunotherapy in the adjuvant setting is allowed
Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
No prior systemic therapy; prior adjuvant therapy with interferon does not count
Patient must have received =< 3 prior cytotoxic regimens for metastatic breast cancer; this does not include cytotoxic regimens used in the adjuvant setting
Prior taxane therapy in the adjuvant or metastatic setting is allowed
No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago
Prior progression on or intolerance to treatment with a fluoropyrimidine and oxaliplatin; recurrence of disease within 6 months from the completion of adjuvant therapy with both a fluoropyrimidine and oxaliplatin is considered progression
Chemotherapy or trastuzumab or bevacizumab in the adjuvant setting is allowed but must have been completed at least 4 weeks prior to study registration; other prior non-hormonal investigational agents in the adjuvant setting must have completed at least 4 weeks prior to study registration and should be discussed with the study principal investigator (PI)
Prior aromatase inhibitors (e.g. anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant setting
Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
Patients who have received other agents that modulate or downregulate the estrogen receptor (e.g. raloxifene, fulvestrant) in the adjuvant setting are eligible if they were on treatment for at least 6 months prior to disease progression in the locally advanced or metastatic setting
If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
Prior treatments:\r\n* Subjects should have received at least two approved HER2-targeted agents (trastuzumab, pertuzumab, or TDM-1) in the course of their disease\r\n* Subjects should have had at least 1 line of prior HER2-targeted therapy in the metastatic setting, with the exception of asymptomatic subjects with oligometastatic or bone/soft tissue only disease who, on investigator opinion, are appropriate for a single agent antiendocrine therapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n*Subjects who have had up to 2 lines of prior endocrine therapy in the metastatic setting are allowed; prior adjuvant and/or neoadjuvant endocrine regimens are allowed and not counted towards this limit
Patients may have received no prior chemotherapy for stage IV disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration
Patients who have progressed/recurred following neoadjuvant/adjuvant chemotherapy for earlier stage disease, if completed within the previous 6 months, are eligible.
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used > 12 months prior to enrollment
Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
Patients may have received no prior chemotherapy for metastatic or unresectable disease; patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration; patients may not have received prior docetaxel or cisplatin
Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
Patients undergoing preoperative or adjuvant chemotherapy
Adjuvant chemotherapy more than 12 months prior to study enrollment.
Patients must have undergone a radical cystectomy (reconstructed urinary diversion may be non-continent diversions (eg, ileal conduits) or continent non-orthotopic catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg, Studer pouch or neobladder) for urothelial bladder carcinoma within 105 days prior to registration; final cystectomy pathology must be either pure urothelial carcinoma or dominant urothelial carcinoma with admixture of other histologies excluding small cell variants\r\n* Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the bladder cancer is permitted; however, all patients, even those who will receive adjuvant chemotherapy must be registered within 105 days after completing cystectomy regardless of whether adjuvant chemotherapy has started; patients who will then receive adjuvant (postoperative) chemotherapy will be randomized within 28 days of completing chemotherapy
Patients must have progressed on, or be intolerant to pertuzumab in the LABC/MBC setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ? 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
No prior therapy for metastatic disease except \r\n* For Group A: > 6 months since completion of adjuvant chemotherapy\r\n* For Group B: those patients who enroll just after completing bevacizumab plus either FOLFOX or FOLFIRI
Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy
For subjects receiving adjuvant therapy only, subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment
Subjects with histologically confirmed stage IV or recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer classification squamous or nonsquamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease\r\n* Prior adjuvant or neoadjuvant chemotherapy is permitted as long as the last administration is at least 2 months prior to enrollment\r\n* Prior definitive chemoradiation for locally advanced disease is also permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 2 months prior to enrollment
No previous radiotherapy, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Naïve to targeted therapy (e.g., BRAFi, MEKi) for advanced disease; prior immune-based therapy in the adjuvant setting or for advanced disease (e.g. interferon alfa, ipilimumab, anti-programmed cell death protein 1 [PD-1], vaccine) will be allowed if > 2 weeks from study entry; prior adjuvant treatment with BRAFi or MEKi will not be allowed
Subject must have received no prior therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. If a subject received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least 6 months after completing the last dose of gemcitabine.
Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
Have received at least 3 months ,of neoadjuvant, adjuvant, or perioperative chemotherapy, including a fluoropyrimidine and either oxaliplatin or irinotecan or both for subjects with initial Stage IV CRC which were treated with surgery with curative intent for both primary and metastatic lesions. The total chemotherapy administered, including that administered prior to and after liver resection, should not exceed 9 months. OR Have received surgery with curative intent for primary CRC and at least 3 months ,of neoadjuvant, adjuvant, or perioperative chemotherapy for the primary tumor, including a fluoropyrimidine or a fluoropyrimidine and either oxaliplatin or irinotecan or both
Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
At least 4 weeks since last adjuvant therapy or other cancer treatment
Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
Patients with unresected metastases from colorectal cancer; patients may be either untreated with chemotherapy or currently receiving first-line 5-FU based chemotherapy (folinic acid-fluorouracil-irinotecan hydrochloride [FOLFIRI], capecitabine-irinotecan hydrochloride [CAPIRI], fluorouracil-leucovorin calcium-oxaliplatin [FOLFOX], or capecitabine-oxaliplatin [CAPOX] with or without bevacizumab) within 10 months of beginning ADAPT therapy with at least stable disease radiographically; patients who received prior adjuvant chemotherapy with 5-FU, capecitabine, or FOLFOX are eligible if adjuvant therapy was completed greater than 6 months ago
Prior 5-FU-based adjuvant chemotherapy less than 6 months prior to beginning ADAPT therapy and any residual neuropathy > grade 2
A subject with non-metastatic castration-resistant prostate cancer (CRPC) may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting > 24 months ago and may not have received prior zoledronic acid or denosumab
Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
Any prior radiotherapy, chemotherapy, surgery, or investigational therapy for adjuvant or metastatic pancreatic cancer
Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1.
For urothelial cancer patients, no prior combination systemic chemotherapy for metastatic disease, except:\r\n* Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy\r\n* Prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided it was completed >= 6 months prior to the diagnosis of metastatic disease\r\n* Prior intravesical therapy is permitted
Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
Adjuvant chemotherapy
Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy
Less than 6 months since prior adjuvant chemotherapy.
No more than two prior chemotherapy regimens administered for the treatment of pancreatic cancer in the adjuvant or advanced/metastatic setting
Prior adjuvant therapy for current melanoma diagnosis;
For all subjects, prior post-operative adjuvant administration of anti-HER2 therapy is permissible.
Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
Adjuvant or neoadjuvant therapy for AGC is allowed.
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
A single measurement greater than 150 ng/dL or 5.2 nmol/L within 3 months of enrollment ii) Subjects with a history of androgen deprivation therapy (either in adjuvant or biochemical relapse setting):
Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least 6 weeks prior to Study enrollment;
Currently receiving adjuvant trastuzumab (Herceptin)
Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion. Prior docetaxel in hormone sensitive setting is allowed if completed >1 year before randomization. Prior immunotherapy is allowed.
The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
No prior anti-cancer therapy for the treatment of metastatic disease at the time of signing the ICF. Adjuvant treatment is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
A single course of gemcitabine and/or docetaxel as adjuvant therapy that was completed at least 6 months prior to planned first dose
Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting.
- oxaliplatin: Patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease
Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation.
Adjuvant therapy < 6 months prior to study day 1.
Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
'Adjuvant therapy' will constitute a prior treatment regimen
Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1)
relapsed while receiving adjuvant therapy with an AI or,
Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
Patients must have completed a course of radiation therapy and at least 2 adjuvant cycles of temozolomide for the phase 2 component.
Patients may or may not have had adjuvant chemotherapy
Has received systemic therapy for the treatment of advanced stage NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease
Patients may not have received more than two prior systemic treatment regimens for distant metastatic disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon, interleukin-2, filgrastim (GM-CSF), ipilimumab, anti-programmed death (PD)1 or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin +/- paclitaxel
Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer; care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (6-9 cycles of platinum and taxane based therapy)
Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)
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.
EXPANSION COHORT A ONLY: more than one prior cytotoxic chemotherapy regimen in the setting of recurrent and/or metastatic disease (cytotoxic chemotherapy given as part of neoadjuvant therapy, adjuvant therapy, or concurrent chemoradiation for curative intent is not included in this exclusion item); this does not apply to expansion cohort B
A patient may be treatment naïve; however, up to two prior regimens for metastatic melanoma are allowed; prior adjuvant interferon (IFN)-alpha is allowed; no prior therapy with bevacizumab, aflibercept or interleukin-2 (IL-2)
Has received ? 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
initial definitive therapy such as surgery with or without adjuvant radiation
Patient may not have previously received chemotherapy for metastatic disease, except adjuvant therapy completed at least 6 months before the first evidence of metastasis
The subject is a candidate for neo-adjuvant chemoradiation therapy
Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
Prior taxanes (except for adjuvant or neoadjuvant therapy more than 6 months prior to treatment day 1) (phase II)
Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
Patient has completed adjuvant radiotherapy (if indicated) according to the institutional guidelines prior to screening
Phase II: Patient who recurs with metastatic disease =< 6 months of completing adjuvant chemotherapy after curative-intent surgical resection is not eligible; patients who recur with metastatic disease > 6 months after completion of adjuvant chemotherapy are eligible
Prior hormonal therapy for recurrent prostate cancer (hormonal therapy given in a neoadjuvant or adjuvant setting and > 6 months before entry is acceptable)
Patients must have completed planned local therapy (i.e., definitive surgery and radiation therapy) and adjuvant chemotherapy for breast cancer prior to registration; in addition, any prior local therapy and adjuvant chemotherapy should be completed prior to participant completion of baseline Patient Reported Outcomes (PRO) instruments (i.e., Health Assessment Questionnaire [HAQ], PROMIS Physical Function, Functional Assessment of Cancer Therapy [FACT] Breast and Endocrine Symptoms [ES], etc.) and collection of optional blood for banking for future research
Patients must not have received prior AI therapy with exemestane, letrozole, or anastrozole as preoperative/adjuvant therapy or for prevention of breast cancer; prior tamoxifen is allowed
Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (ongoing herceptin or other chronic human epidermal growth factor receptor [HER] 2 directed therapies are allowed)
Has received adjuvant endocrine therapy (selective estrogen receptor modulator [SERM] alone, gonadotropin-releasing hormone [GnRH] analogue plus SERM or aromatase inhibitors [AI]) for >= 18 months but =< 30 months for early breast cancer\r\n* Note: patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible
Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)
Planning to undergo adjuvant or neoadjuvant chemotherapy for stage I-III breast cancer
Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense doxorubicin, cyclophosphamide, and paclitaxel (ACT)
In active cancer treatment or have completed active cancer treatment within 12 months of obtaining consent (with the exception of adjuvant hormonal therapy)
Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines
Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting (AC may be administered every 2 or 3 weeks, and may be preceded by or followed by paclitaxel planned to be given at 80 mg/m^2 weekly or 175 mg/m^2 every 2-3 weeks, per standard treatment plan) OR metastatic prostate adenocarcinoma for which docetaxel will be administered (between 60 mg/m^2 to 75 mg/m^2 every 3 weeks)
Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy
Neo-adjuvant systemic therapy
Cohort 1: First-line soft tissue sarcoma of intermediate or high grade. Adjuvant or neoadjuvant chemotherapy allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
Cohort 2: Soft tissue sarcoma of intermediate or high grade with evidence of disease progression by either CT or MRI scan, or clinical judgment on or after the last cancer therapy within 6 months prior to the start of study treatment. Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation. Patients who have previously received anthracyclines are eligible if cumulative exposure is <375 mg/m2 for doxorubicin and liposomal doxorubicin or <675 mg/m2 for EPI.
Participants must have already received or been intolerant to at least two lines of hormonal therapies (including the adjuvant or metastatic setting) or be appropriate candidates for chemotherapy
Subject must have previously received or be intolerant to anthracycline based therapy for advanced (metastatic or inoperable) disease. Subjects who received neoadjuvant/adjuvant anthracycline based therapy and progressed within 6 months of completion of therapy will be eligible
First-line cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior = adjuvant therapy if completed >= 6 months prior to start of first line chemotherapy for metastatic disease)
Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy
Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy
Post neoadjuvant or adjuvant chemotherapy, if prescribed
Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
Treatment plan that doesn’t include neo-adjuvant radiation and surgical excision
Stage I-III breast cancer\r\n* Treatment status: At least 6 months and no more than 5 years after the conclusion of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered\r\n*NOTE: Adjuvant HER2-targeted therapy and endocrine therapy may still be ongoing at the time of study enrollment; those on endocrine therapy must have been on their current endocrine regimen for at least four weeks prior to study enrollment and must not have plans to change endocrine regimens during the study period
Prior chemotherapy in the neoadjuvant or adjuvant setting
No plan for adjuvant endometrial cancer therapy
Patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment
4) Patients on adjuvant hormone therapy for less than 2 months.
Participants will have completed surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy and with or without radiation
Have completed primary treatment for their cancer; primary treatment will be defined as having completed all (a) definitive cancer surgery, (b) (neo)adjuvant chemotherapy, and/or (c) (neo)adjuvant radiation; breast cancer patients still receiving adjuvant endocrine or human epidermal growth factor receptor 2 (HER2) targeted therapies are eligible, as would colon cancer patients receiving a targeted agent; if there is any question whether a patient meets this eligibility requirement, Dr. Tevaarwerk (co-I, Oncology) will adjudicate
Treatment plan that includes any neoadjuvant or adjuvant therapy (either in the context of standard treatment or a clinical trial and including chemotherapy, treatments targeting the human epidermal growth factor receptor protein 2 [HER2]), hormonal therapy, or radiation; patients can receive any/all of these therapy components while on study in any combination
Planned primary or adjuvant chemoradiation therapy
BRAIN CANCER: Starting adjuvant temozolomide therapy
Planned (neo)adjuvant therapy with trastuzumab (Herceptin) plus chemotherapy
Completed neo-adjuvant or adjuvant chemotherapy
Currently take adjuvant AI therapy
Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as > 12 months [mo])
Currently receiving taxane-based chemotherapy (either adjuvant or neoadjuvant)
> 6 months post local and/or adjuvant therapy
Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org); patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
Cases with stage I-IIIB breast cancer that have completed neoadjuvant or adjuvant treatment with anthracyclines and/or taxanes + or – radiation therapy within past 6 months (+/- 7 days) (subjects on concurrent endocrine therapy [tamoxifen (TAM), aromatase inhibitors] are also eligible to participate)
Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
Have completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation; participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible
Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
Currently receiving or have plans for adjuvant radiation or chemotherapy
Potential participants are women who have a diagnosis of invasive breast cancer (stage I-III) and are anticipated to start neo-adjuvant or adjuvant chemotherapy with an anthracycline and/or a taxane lasting 18-24 weeks with or without ovarian suppression
Women enrolled at Kansas University Medical Center (KUMC), should be willing to undergo brain magnetic resonance imaging (MRI) at baseline prior to starting neo-adjuvant or adjuvant chemotherapy, again just before starting the first dose of the last cycle of neo-adjuvant chemotherapy prior to scheduled surgery or 3 weeks after the last cycle of adjuvant chemotherapy, and ~6 months after completion of neo-adjuvant or adjuvant chemotherapy, unless one of the following circumstances apply: 1) claustrophobia, 2) medical contraindication, 3) metal implants, or 4) cannot be scheduled prior to scheduled start of neo-adjuvant or adjuvant chemotherapy; women will be screened by the study coordinator and staff at the Hoglund Brain Imaging Center for final eligibility to undergo fMRI (e.g., no metal implants, claustrophobia, medical contraindications); note that women declining an fMRI or in whom MRI cannot be scheduled prior to start of neo-adjuvant therapy will still be able to participate in the rest of the study but will not have a subsequent research related MRI
For patients not receiving adjuvant therapy, end of therapy will be defined as six months post diagnosis (patient)
Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab; participants must be within their first two rounds of chemotherapy
Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting aim 1
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
Diagnosis of breast cancer with adjuvant chemotherapy treatment
SCREENING PHASE: Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel
INTERVENTION PHASE: Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane
Planned paclitaxel at a dose of 80 mg/m^2 intravenously (IV) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities present
Stage I-III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
Completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or human epidermal growth factor receptor 2 (HER-2) directed therapy
Scheduled to undergo adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy
Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to 60 Gy in 30 fractions in the adjuvant or definitive setting
Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin
Scheduled to receive adjuvant or neoadjuvant trastuzumab therapy            \r\n* Anthracycline-containing regimens allowed\r\n* Patients receive trastuzumab with their chemotherapy allowed for eligibility work-up\r\n* Taxanes are allowed\r\n* Trastuzumab therapy may be given with or after primary chemotherapy
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
Patients who are receiving a course of radiation therapy for curative or adjuvant intent
Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only)
Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies
Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
Receiving definitive or post-operative adjuvant radiotherapy
Completed chemotherapy > 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion)
In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:\r\n* If no adjuvant therapy, register patient within 75 days following surgery\r\n* If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery\r\n* If adjuvant chemotherapy and radiation, register patient within 285 days following surgery
Scheduled to receive adjuvant therapy consisting of doxorubicin followed by trastuzumab
Completed an approved regimen of neoadjuvant or adjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy with plan for completion of one year of trastuzumab therapy.
Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled
Neoadjuvant or adjuvant therapy of any kind
Participants must not have received either chemotherapy or radiotherapy within the previous 6 months; Note: participants receiving long-term adjuvant hormonal therapy (such as tamoxifen or aromatase inhibitors for breast cancer) are allowed
Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program
Subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable provided it was administered at least 1 year prior to study entry.
Patient may have had any number of prior chemotherapy regimens in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior treatments with anti-HER2 strategies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior hormonal therapies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment.
Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
Patients with adenocarcinoma arising from the esophagus, gastroesophageal junction, or stomach must also meet the following criteria: a. Must have received prior treatment with a platinum/fluoropyrimidine-based therapy with or without an anthracycline in the metastatic setting; or, in the adjuvant setting if recurrence occurred within 6 months of completing systemic adjuvant treatment; b. Patients with HER2 positive tumors must have had prior treatment with a Her2 inhibitor (e.g. trastuzumab or lapatinib); c. Patients who have received prior taxane therapy may be enrolled.
Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
Participants may or may not have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose of chemotherapy and/or biological therapy, with no more than grade 1 residual toxicity at the time of screening
Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
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).
Operable and necessitates adjuvant or neo-adjuvant treatment
Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated > 2 years prior to diagnosis of metastatic disease\r\n* Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline
No prior history of androgen deprivation therapy within the last month; however patients who will receive neoadjuvant and concurrent and adjuvant hormonal therapy will be eligible
Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed)
No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2 years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES.
Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
The patient must have completed adjuvant chemotherapy more than 6 months ago, but no more than 36 months prior to initial study scan
Neo-adjuvant hormonal therapy
Subjects who have received prior adjuvant therapy for pancreatic adenocarcinoma are eligible if neoadjuvant and adjuvant therapy (including chemotherapy and/or radiotherapy) was fully completed more than 4 months before the start of study treatment. In this case, prior Gem and/or NP is allowable
No prior treatment with carboplatin in the metastatic setting; carboplatin in neoadjuvant/adjuvant setting may be allowed if prior treatment with carboplatin was completed at least one year prior to initiation of this study and after discussion with the study chair
Gastric Carcinoma (including Gastro-Esophageal Junction Adenocarcinoma): progression following at least one prior line of standard therapy that contained a fluoropyrimidine and/or platinum and/or taxane agent; prior adjuvant or neoadjuvant therapy is counted as one regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy; HER2 negative subjects (defined by HER2 ? 2+ by IHC) by medical history; archival tissue or fresh tumor biopsy
Patients must have received at least one prior therapy for unresectable disease; patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy may be considered as having received one prior therapy for unresectable disease
Clinical need for adjuvant chemotherapy
Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject
For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
Received any adjuvant chemotherapy
For adjuvant setting patients, any treatment received after surgery
No neoadjuvant endocrine therapy or chemotherapy within 12 months
Prior history of cancer, neo-adjuvant chemotherapy and radiation therapy
Have a primary diagnosis of non-metastatic colorectal cancer and have had surgery and are now receiving adjuvant chemotherapy
Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted; this treatment may be neoadjuvant or adjuvant chemotherapy; patients must not be receiving or planning to receive concurrent radiation during systemic treatment
Completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
Neo-adjuvant hormonal therapy
Previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy
Prior treatment with gemcitabine-containing therapy for advanced disease (adjuvant therapy is allowed, provided not more than six cycles were administered and relapse occurred more than six months after the last drug administration), and/or:
any neo-adjuvant therapy
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
They show evidence of disease progression during or within 12 months of the end\n                  of adjuvant ET.
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
For Adjuvant Treatment: No prior treatment with BTZ, CFZ, or IXZ
For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.
Prior treatment must include an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting with the exception for participants who are clinically contraindicated for these chemotherapies.
Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
Women more than 180 days out from primary breast surgery or adjuvant chemotherapy