[c09aa8]: / clusters / 9knumclustersv2 / clust_2529.txt

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Patients must not have had systemic chemotherapy or immunotherapy, including, but not limited to interferon alfa-b, high dose interleukin (IL-), pegylated interferon (PEG-IFN), anti-programmed cell death protein (PD-), anti-PD-L, intra-tumoral, or vaccine therapies within weeks prior to cycle , day ; patients must not have received or be planning to receive any of the prohibited therapies during protocol treatment; prior intravesical interferon therapy is allowed
No concurrent treatment with other cytotoxic drugs or targeted therapies
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for weeks prior to the initiation of study treatment and must have recovery =< grade from any adverse events of these therapies (other than alopecia); prior treatment with any PARP inhibitor or any anti-PD-/anti-PD-L antibody is NOT allowed
Patient has persistent toxicities from prior MDS therapies which are determined to be relevant by the Investigator.
Patients may have had - prior therapies\r\n* Prior chemoembolization or local ablative therapies are permitted if completed >= weeks prior to study enrollment\r\n* Prior temozolomide is permitted
Receipt of treatment with immunotherapy, biological therapies, targeted small molecules, hormonal therapies within weeks of scheduled CD dosing.
Co-administration of anti-cancer therapies other than those administered in the study
Must have been treated with at least prior systemic therapies.
Patients currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, ALT- and supportive care therapies.
Patients are eligible for available approved standard therapies
Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)
Not amenable to approved therapies
Have discontinued all previous therapies for cancer.
Discontinuation of previous cancer therapies at least four () weeks prior to treatment in this study.
Other therapies: Prior experimental (non-Federal Drug Administration [FDA] approved) therapies (other than drugs that share the same target) and immunotherapies are allowed; patients must not have received these therapies for days or five half-lives of the drug (whichever is less) prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
Active residual toxicity from prior therapies.
Treatment with any of the following prior therapies:
All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
Prior anti-cancer therapies for current malignancy
Patients with known oncogenic mutations for which there are approved therapies must have documented intolerance or disease progression for the approved therapies for their mutation. For Other Indications
Female or male subjects whose advanced HER expressing cancer has failed standard of care treatments, or for whom such therapy is not acceptable to the subject. Subjects with advanced breast and gastric cancer who test positive for HER by ASCO/CAP criteria (either IHC or FISH) must have received prior treatment with a trastuzumab containing therapy. Subjects who have been previously treated with pertuzumab, TDM-, lapatinib, or other available and accessible HER-directed therapies or investigational therapies are eligible.
two prior hormonal therapies;
Men and Women > years of age with Eastern Cooperative Oncology Group (ECOG) performance status < ; a. Eligibility: U.S. Sites Includes subjects with loco-regional disease that have relapsed/recurred within months of chemo-radiation and who have no standard of care. Includes patients (subjects) with metastatic disease having injections into only superficial lesions that have failed (includes progression, relapse or intolerance) or not be a candidate for approved therapies. Note, patients (subjects) that have approved therapies available, which might confer clinical benefit, may be enrolled as long as the physician properly explains the nature of the treatment, and obtains consent \. Includes patients (subjects) with metastatic disease having at least one deep tumor injection who have failed (includes progression, relapse or intolerance) all approved lines of therapy prior to enrollment unless they are not an appropriate candidate for a particular approved therapy or no approved therapy exists. Note: There is no limit on the number of prior therapies that a patient (subject) may have received prior to enrollment in any cohort. b. Eligibility: Canadian Sites Subjects with advanced or metastatic solid tumors that have disease progression after treatment with approved, available therapies (in site's country) for the cancer type or for whom available therapies have limited benefit and the subject refuses the available therapy. Includes subjects with locoregional disease that have relapsed/recurred within months of chemo-radiation; or who have no standard of care or beneficial options. No limit on the number of prior treatments;
Patients who have received other cell therapies
Part C) Triple-negative disease and received - prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
At least weeks post any treatments/therapies at the time of first dose.
Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-, or vaccine therapies or herbal therapies
Patients may not receive any other anti-cancer therapies, within days prior to registration and throughout the duration of this trial
Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
Patients are not eligible if they are using any other approved or investigational anti-neoplastic therapies or any other investigational therapies for any other reason.
Not amenable to approved therapies
Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer.
PART II: Recurrent or progressive metastatic disease after standard of care HER-targeted therapies i.e. trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb), ado-trastuzumab emtansine (TDM) (Kadcyla) or other HER-directed therapies
There is no limit on prior systemic or IT therapies
Insufficient recovery from all active toxicities of prior therapies
Patients with a history of prior adoptive cell therapies.
Received chemotherapy, radiotherapy, immunotherapy, or any investigational cancer therapies within days prior to the first dose of enzalutamide and/or CORT, or treatment with such therapies is planned during protocol treatment
The participant may have no more than prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ? weeks ( days) prior to first dose of study drug.
EXCLUDED THERAPIES AND MEDICATIONS FOR CANCER
There are no specific restrictions for therapies to treat cGVHD
Prior systemic, regional and radiation anticancer therapies must have been completed at least three months prior to enrollment; prior therapies (including anti-PD- inhibitors) is allowed provided three months have elapsed from last dose
Phase : Received prior therapies with eribulin mesilate or irinotecan.
Unlimited prior therapies allowed
Patients who are currently undergoing other anti-tumor therapies or have concurrent active cancer
Patients on bisphosphonates or RANK-L inhibitors may continue receiving these therapies during study treatment; there is no washout period required between the last dose of these therapies and the start of abemaciclib
Ongoing or planned administration of anti-cancer therapies other than nivolumab
Any other previous antitumor therapies for the current cancer event; this exclusion does not apply to phase Ib part of cohort
Hormonal tumor therapies should not be administered within days of registration; exceptions may be discussed with the PI
PCSPES or PCx products; other herbal therapies or supplements will be considered by the principle investigator on a case-by-case basis based on their potential for hormonal or anticancer therapies
Subjects must have received no prior therapies for this disease
Symptomatic subjects who accept treatment with approved palliative or life-prolonging systemic therapies, including docetaxel and cabazitaxel chemotherapy; (Note: subjects who refuse chemotherapy or are not symptomatic or in immediate need for standard systemic therapies may be included)
Subjects who have received anti-CD targeted therapies, chimeric antigen receptor T-cell or other cellular therapies for the treatment of their lymphoma .
Patients may not have received prior HER directed therapies
Prior use of other retinoid therapies in the months prior to enrollment in the study
Histiocytic disorder must be (a) multi-system disease or (b) disease that is recurrent or refractory to standard therapies, or (c) single-system disease that is unlikely to benefit from conventional and less toxic therapies, based on the best available evidence (for example, central nervous system [CNS] or cardiac infiltration, retroperitoneal fibrosis, prior chemotherapy, or other medical history or co-morbidities, etc)
Required washout period for prior therapies Topical therapy: weeks
Co-administration of anti-cancer therapies other than those administered in this study
Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
Patients with previously untreated AML (by the World Health Organization [WHO] criteria, i.e. >= % blasts); prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents -azacytidine or decitabine; patients must have been off such therapy for week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease; hydroxyurea, and a single dose of cytarabine up to g/m^, is permitted for control of counts prior to treatment
Prior therapies:\r\n* For patients stratified to the untreated arm:\r\n** Untreated patients should have received zero prior therapies for metastatic disease\r\n** They may have received prior adjuvant chemotherapy and/or radiation therapy, but not within months prior to treatment\r\n** They may have received prior palliative radiation therapy for unresectable disease, but without any systemic chemotherapy, even as a radiosensitizer\r\n* For patients in the previously treated arm:\r\n** Previously treated patients may have received any number of prior therapies\r\n** Patients who received prior adjuvant chemotherapy and/or radiation therapy within months of treatment will be considered previously treated\r\n*** Patients may have received any prior therapies EXCEPT prior therapy with a PARP inhibitor\r\n** Timing of prior therapies:\r\n*** At least days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy\r\n*** However, at least days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n*** Additionally, at least days must have passed since any prior investigational agent\r\n*** All patients must have completely recovered from all transient side effects related to prior therapies\r\n**** However, any side effects that are expected to be more durable or even permanent (e.g., neurotoxicity or ototoxicity) must have resolved to at least grade
No limitations on prior therapies
Arms B-B: Has undergone - previous regimens of cytoreductive chemo-therapies Arm B: with no prior exposure to anti-PD-(L) therapies and have received no prior systemic treatment for RM SCCHN
Insufficient recovery from all active toxicities of prior therapies
First or later relapse AND has received at least prior therapies (one of which can be frontline therapy) or
Arm : Subjects must have received at least one prior therapy and a maximum of three prior therapies
Failed available therapies (pancreatic cancer may be treated without previous therapies)
Prior toxicity to anti-FGFR-directed or anti-PIK-directed therapies leading to treatment discontinuation (previous exposure is allowed in other circumstances).
Any previous antitumor therapies for the current cancer event
Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last years.
Patient has any prior use of anti-androgen therapies.
Participants requiring the use of anti-tumor necrosis factor (anti-TNF) therapies, such as infliximab, or has received treatment with anti-TNF therapies within half-lives of the drug
No more than two () prior anti-cancer therapies for aBC
Plan to receive anti-myeloma therapies
Not eligible for cytotoxic therapies
All patients must have received, and be relapsed/refractory to at least one line of systemic therapy\r\n* NOTE: This does not include surgery or radiation alone; patients may have received any number of systemic therapies\r\n* NOTE: For patients with aggressive lymphoma, there should be no other standard therapies that would confer survival benefit
Subjects must have progressive cancer at the time of study entry; prior experimental (non-Food and Drug Administration [FDA] approved) therapies (other than drugs that share the same target) and immunotherapies are allowed; patients must not have received these therapies for days or five half-lives of the drug (whichever is less) prior to the initiation of study treatment; toxicities from these therapies should have recovered to =< grade , with the exception of stable chronic grade that is not overlapping with presumed toxicities of olaparib
Discontinuation of other therapies (except corticosteroids) for the treatment of NF\n and resolution of any acute toxic effects of prior therapies
Patients with prior investigational therapies within weeks before treatment with\n APC-
c. Colorectal Cancer -Enrollment Completed Metastatic or recurrent; prior treatment progression during, after, or intolerant following the last administration of approved standard therapies (required therapies apply).
Must have received or prior anti-angiogenic therapies.
Use of any monoclonal based therapies within - weeks prior to the first dose of study treatment.
No more than prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK/ inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL or VEGF)
at least HER-directed therapies for advanced disease
Inadequate response, relapse, and/or unacceptable toxicity with ? prior systemic, surgical, or radiation cancer therapies.
Use of certain investigational therapies within days prior to enrollment
Patients must not have received neoadjuvant treatment for their melanoma; patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-b, high dose IL-, pegylated (PEG)-IFN, anti-PD-, anti-PD-L intra-tumoral, or vaccine therapies; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
Inadequate response, relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, and for whom curative standard therapy is not an option (except patients with NSCLC who must have experienced either an inadequate response, relapse, and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies)
Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX), as follows:
Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
Subjects of years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
Any prior use of hormonal therapy, including:\r\n* Gonadotrophin releasing hormone (GNRH) agonists or GNRH antagonists (e.g., leuprorelin, degarelix)\r\n* Antiandrogens (e.g., bicalutamide, flutamide, nilutamide)\r\n* Novel androgen-directed therapies (e.g., abiraterone, enzalutamide)\r\n* Any estrogen containing compounds\r\n* -alpha reductase inhibitors (e.g., finasteride, dutasteride)\r\n* PC-SPES or PC-x products; other herbal therapies or supplements will be considered by the principle investigator on a case by case basis based on their potential for hormonal or anti-cancer therapies
Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= year prior to randomization) a) <= years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Patients must have received at least prior therapies.
Other investigational therapies
Any other previous antitumor therapies for the current cancer event
Have mCRC that has been treated with currently approved standard therapies
Current or recent treatment with biologic anticancer therapies
Ongoing AEs from prior anticancer therapies
Co-administration of anti-cancer therapies other than those administered in this study
Ongoing or planned administration of anti-cancer therapies other than those specified in this study
Received any of the following prescribed medications or therapies in the past:
Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
Must have received at least prior approved therapies
Herbal therapies, with an antitumor effect.
Prior therapy with axitinib as well as any prior therapies with other VEGF pathway inhibitors.
Ongoing or planned administration of anti-cancer therapies other than those specified in this study
Hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards line limit considerations
Insufficient recovery from all side effects of previous anticancer therapies
Progression on at least lines of anti-HER-targeted therapies for metastatic breast cancer (MBC)
Patient must have received at least one, and no more than two prior systemic therapies for metastatic cancer
Patients who have received previous systemic therapies including TKI inhibitors are eligible.
Taking investigational or commercial agents or therapies with the intent to treat the subject's malignancy other than those therapies permitted
RESTRICTED THERAPIES:
Patients must be off all other anti-tumor therapies (including immunologic or hormonal agents) for at least four weeks prior to study registration
Cancer vaccines and convection-enhanced therapies: interval >= month before study enrollment
Received any of the following antitumor therapies
Investigational or biologic therapies within weeks of CD
Prior therapies:
Plan for chemotherapy or targeted therapies during WBRT or over the subsequent days
Received other therapies as follows:
Patients who have received more than two prior therapies
Receipt of any biological or immunological-based therapies (including experimental therapies) for leukemia, lymphoma, or myeloma (including, but not limited to, MAb therapy such as rituximab, or cancer vaccine therapies) within days or half-lives, whichever is shorter, prior to the first dose of MEDI-
At least weeks post any treatments/therapies at the time of first dose.
Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
days for non-cytotoxic cancer therapies and radiotherapy
Immunosuppressant therapies other than allowed background therapy
Most prior therapies and prior targeted therapy are allowed and these specific therapies are detailed in the protocol.
Patient must have received at least one line but less than three lines of prior systemic therapies and have either progressed or intolerant to prior therapies; patients who have received adjuvant/neoadjuvant therapy within last one year will be eligible as well
Must have received at least prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD targeted therapy. At least prior therapies where CD targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject. DLBCL Dose Expansion Arm:
to prior therapies
Excluded previous therapies and medications:
Prior treatment with any investigational or targeted therapies
Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within days prior to first dose of TH-.
Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
For investigational anti-cancer therapies, the interval will be determined in consultation with the Medical Monitor.
No other systemic therapies for prostate cancer within days prior to initiation of this protocol
< days for any antibodies or biological therapies
Standard therapies are considered intolerable
Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.
Use of antineoplastic therapies within days before day .
Receipt of treatment with immunotherapy (including interferons, interleukins, immunoconjugates), biological therapies (including monoclonal antibodies or other engineered proteins), targeted small molecules (including but not limited to kinase inhibitors), hormonal therapies (except for gonadotropin releasing hormone agonists/antagonists for prostate cancer which may be continued while on study) within weeks of scheduled dosing day .
Being treated with other anti-cancer therapies (approved or investigational).
Concurrent administration of any anti-cancer therapies other than those administered in this study
Discontinuation of all other therapies for treatment of iNHL ? weeks before Visit
Subject has not discontinued all previous systemic therapies for cancer including chemotherapy, immunotherapy, or biological therapies for at least days prior to the initiation of ASP.
Has received other anti-cancer therapies other than IMO- since enrolling in Protocol -.
Being treated with other anti-cancer therapies (approved or investigational)
Treatments in this category include chemotherapy and targeted therapies not targeting VEGF; days must have elapsed since discontinuation of prior chemotherapeutic treatments for glioma and study treatment
Must have received or may still be receiving one or more therapies including octreotide or serotonin synthesis inhibitor (SSI) or other somatostatin analogues
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Histologically or cytologically confirmed gastrointestinal (GI) carcinoma, which has progressed on standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy), for which effective therapy is not available or for which patients are not a candidate for or intolerant of such therapies.
Co-administration of anti-cancer therapies other than those administered in this study
Anticipated or ongoing administration of anti-cancer therapies other than those administrated in this study
No limit to prior therapies with last anti-cancer treatment >= weeks from initiation of WBRT; please note: there is no washout period required for trastuzumab and pertuzumab
Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
Must not be receiving other anti-cancer therapies (except somatostatin analogues, which may be allowed)
Some prior cancer therapies are not consistent with eligibility; specifically:
May have up to three biological therapies
Patients planning on receiving other anti-cancer therapies while on this study
Patient has received any of the following therapies:
Patients receiving other investigational therapies
Received prior therapies including:
Concurrent use of alternative cancer therapies
Prior warfarin-based therapies within days of capecitabine treatment
Less than prior systemic cancer therapies (with the exception of hormonal agents), including experimental agents, prior HER-family TKI therapies, and prior docetaxel and other taxane therapy; there are no limits to the number of prior therapies for Part
- months post-treatment (surgery, chemotherapy, radiation therapy, and/or maintenance therapies) for cancer; time frame applies to most recent completion of treatment if participant had a cancer recurrence; it is acceptable to be on hormonal therapies
COHORT A SPECIFIC INCLUSION: Histologically confirmed IDHwt, retinoblastoma (RB) intact, grade II or III glioma that has recurred after first line therapy (consisting of at least maximum feasible surgical resection and radiation therapy); there is no limit on the number of prior therapies or types of therapies patients can have received
Have received more than prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
Patients on anti-hormonal therapies (e.g., anti-estrogens for breast cancer) or other maintenance therapies will be eligible.
Plan to receive or is receiving primary frontline anti-myeloma therapies
Completed treatment for breast cancer (except hormonal therapies) within months.
Are not within months of completing treatment for breast cancer (except hormonal therapies) at the time of recruitment;
Subject has not started any new systemic immunosuppressive therapies within weeks prior to enrollment
Failure of previous HCV therapies
History of serious side effects from nicotine or from any nicotine replacement therapies
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
Patients may be enrolled between - months from completion of standard primary breast cancer therapies
No limit to prior therapies with last anti-cancer treatment >= weeks from initiation of WBRT; please note: there is no washout period required for trastuzumab, pertuzumab for patients who have developed new parenchymal brain metastases while on these agents
Prohibited treatments and/or therapies:\r\n* Prior history of breast cancer surgery and/or radiotherapy
Patients can have had any number of prior therapies, including but not limited to molecularly targeted therapies and anti-angiogenic therapies, however they must have had prior chemotherapy with either temozolomide or lomustine
Patients must not have received any study therapies prior to registration
Patients on any experimental anti-EGFR targeted therapies
Has undergone ? prior standard therapies