Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events of these therapies (other than alopecia); prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 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 0-4 prior therapies\r\n* Prior chemoembolization or local ablative therapies are permitted if completed >= 6 weeks prior to study enrollment\r\n* Prior temozolomide is permitted
Receipt of treatment with immunotherapy, biological therapies, targeted small molecules, hormonal therapies within 3 weeks of scheduled C1D1 dosing.
Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry
No limit on number of prior therapies
Co-administration of anti-cancer therapies other than those administered in the study
Must have been treated with at least 2 prior systemic therapies.
Participants are permitted to have any number of prior therapies prior to enrollment
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.
Any number of prior chemotherapies and targeted therapies are allowed
Melanoma after failure of available therapies
Any number of prior systemic therapies.
Discontinuation of previous cancer therapies at least four (4) 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 30 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.
At least one line of prior systemic therapy for metastatic or recurrent breast cancer (there is no limit to the number of prior 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
two prior hormonal therapies;
No limit to number of prior therapies
There is no limit to number of prior therapies
Patients who have received other cell therapies
Part C) Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
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)-2, or vaccine therapies or herbal therapies
Patients may not receive any other anti-cancer therapies, within 28 days prior to registration and throughout the duration of this trial
PHASE I: No limit on the number of prior systemic therapies for metastatic disease
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
There is no limit on the number of prior therapies
Must have received first line chemotherapy; no upper limit to number of prior therapies
Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer.
There is no limit on prior systemic or IT therapies
Patients with a history of prior adoptive cell therapies.
Received chemotherapy, radiotherapy, immunotherapy, or any investigational cancer therapies within 28 days prior to the first dose of enzalutamide and/or CORT125281, or treatment with such therapies is planned during protocol treatment
The participant may have no more than 2 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 ? 3 weeks (21 days) prior to first dose of study drug.
Any number of prior therapies are allowed
EXCLUDED THERAPIES AND MEDICATIONS FOR CANCER
There are no specific restrictions for therapies to treat cGVHD
Patients can have any number of prior therapies and any amount of time period from the last therapy as long as they have complete response as seen in PET/CT at the time of enrolment
Prior systemic, regional and radiation anticancer therapies must have been completed at least three months prior to enrollment; prior therapies (including anti-PD-1 inhibitors) is allowed provided three months have elapsed from last dose
Any number of prior therapies is allowed
Unlimited prior therapies allowed
Patients may have received an unlimited number of prior therapies
Relapse following first line immunotherapy or chemoimmunotherapy; there is no upper limit to the number of therapies received prior to study entry; prior therapies may include high-dose therapy with autologous stem cell rescue
Patients may or may not have received prior therapy for their recurrent/metastatic disease\r\n* NOTE: There is no limit to the number of prior therapies for stage IV disease\r\n* NOTE: Patients should not be a candidate for curative surgical treatment or radiation (palliative radiotherapy is permitted)
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
There is no limit on number of prior therapies
Hormonal tumor therapies should not be administered within 14 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
The number of prior therapies is restricted as follows:\r\n* Zero or one prior therapies during the preceding one year; this serves to limit the treatment cohort to patients with either only slowly progressive disease, or up to one prior therapy\r\n* No prior PD-1 or PD-L1 antibody therapies are allowed\r\n* Prior IL-2 is allowed, if it finished more than 1 year prior
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 19 targeted therapies, chimeric antigen receptor T-cell or other cellular therapies for the treatment of their lymphoma .
Any prior number of prior therapies, including prior immunotherapy, is allowed
Any number of prior therapies (including none) is permitted; the last dose of systemic therapy (include targeted therapies) must have been given at least 4 weeks prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
Patients may be treatment naive or have received any number of prior therapies\r\n* NOTE: Prior immunotherapy is contraindicated and not permitted
Patients may not have received prior HER2 directed therapies
Receipt of therapies or procedures prior to first dose including:
Prior use of other retinoid therapies in the 3 months prior to enrollment in the study
Any number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteria
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)
Subject who received any therapies intended to treat malignancy within 21 days of first receipt of DS-3032b
Required washout period for prior therapies Topical therapy: 2 weeks
Co-administration of anti-cancer therapies other than those administered in this study
Any number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteria
Patients may be previously untreated or have received up to 3 prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use in the adjuvant or metastatic disease settings is permitted (in this trial interferon is mainly used to enhance or initiate immune responses to MK-3475); vaccine therapy will not be counted as systemic therapy; all prior therapies must have been discontinued for at least 4 weeks; a 2 week washout for kinase inhibitors is acceptable
Patients may have had any number of prior systemic therapies; patients need not have exhausted standard therapy for their disease, but must be stable and must not have actively progressing
Any number of prior therapies is allowed
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 6 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 6 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 14 days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy\r\n*** However, at least 28 days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n*** Additionally, at least 28 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 1
No limitations on prior therapies
Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN
MDS at any stage; prior therapies allowed
First or later relapse AND has received at least 2 prior therapies (one of which can be frontline therapy) or
Receipt of all standard therapies for the tumor type:
Refractory disease, having failed available therapies
Arm 1: 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)
Any previous antitumor therapies for the current cancer event
Failed >= 2 prior systemic therapies
Prior treatment within 21 days of the first dose of study drug with any other chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment, or failure to recover from adverse effects of prior therapies administered over 4 weeks prior to study day 1; all toxicities from prior therapies must be =< grade 1 (or =< grade 2 for alopecia or peripheral neuropathy); prior systemic treatment in the adjuvant setting is allowed
Participants requiring the use of anti-tumor necrosis factor (anti-TNF) therapies, such as infliximab, or has received treatment with anti-TNF therapies within 5 half-lives of the drug
Any number of prior endocrine therapies is allowed and must be discontinued prior to randomization
Any number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed >= 28 days prior to randomization
No more than two (2) prior anti-cancer therapies for aBC
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 30 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 1, with the exception of stable chronic grade 2 that is not overlapping with presumed toxicities of olaparib
There is no limit to number of prior therapies
Discontinuation of other therapies (except corticosteroids) for the treatment of NF2\n             and resolution of any acute toxic effects of prior therapies
Progression on, or intolerance of, or ineligibility for all standard therapies
There is no limit to the number of prior therapies
Patients treated with other secondary hormonal therapies
Patients with prior investigational therapies within 4 weeks before treatment with\n             APC-100
1c. 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 1 or 2 prior anti-angiogenic therapies.
Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).
at least 2 HER2-directed therapies for advanced disease
Inadequate response, relapse, and/or unacceptable toxicity with ? 1 prior systemic, surgical, or radiation cancer therapies.
Use of certain investigational therapies within 21 days prior to enrollment
Participants in Stage 1 (Safety Evaluation) receiving erlotinib: No limit to the number of prior therapies (except for EGFR TKIs).
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)
Any number of prior therapies is allowed
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 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* 5-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
Patients must have received at least 2 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
Failure, ineligible or intolerant of approved therapies; any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma; this includes chemotherapy, immunotherapy, pathway inhibitors, biochemotherapy, or investigational treatments; patients may also have received therapies in the adjuvant setting
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
May have received prior therapies for advanced or metastatic disease
Received any of the following prescribed medications or therapies in the past:
Must have received at least 2 prior approved therapies
Any number of prior therapies other than oxaliplatin is allowed
Herbal therapies, with an antitumor effect.
Ongoing or planned administration of anti-cancer therapies other than those specified in this study
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.
Participants are permitted to have any number of prior therapies prior to enrollment
Other available therapies have failed to cure the cancer
Taking investigational or commercial agents or therapies with the intent to treat the subject's malignancy other than those therapies permitted
RESTRICTED THERAPIES:
At least 1 prior treatment (no restriction to number of prior therapies)
Participants may have received any number of prior therapies as long as they have adequate performance status and meet all other eligibility criteria
Patients may have received any number of prior CNS directed therapies - there are no limitations
Patients must have received at least one prior line of therapy for their advanced lung cancer but there is no restrictions on the maximum number of prior therapies allowed
Prior treatment with embolization of ablative therapies is allowed if measurable disease remains outside of the treated area or if there is definite progression of the treated lesions; there is no limit on the number of prior procedures
Must have received first line chemotherapy; no upper limit for the number of prior therapies
Participants may have received up to 2 prior cytotoxic chemotherapies; there is no limit to the number of lines of prior biologic or hormonal therapies they may have had; patients must be platinum resistant
Participants may have received any number of prior cytotoxic chemotherapies; there is no limit to the number of lines of prior biologic or hormonal therapies they may have had; patients may be platinum-sensitive or resistant or refractory
Received any of the following antitumor therapies
Prior therapies:
Received other therapies as follows:
Must have received at least 2 prior therapies approved for CRPC; including a prior AR inhibitor (e.g., enzalutamide or apalutamide). (Part 1 only)
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 28 days or 5 half-lives, whichever is shorter, prior to the first dose of MEDI-551
Patients may have received any number of prior therapies, including monotherapy with liposomal doxorubicin or bevacizumab
Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
At least three weeks from any non-anti-EGFR therapy prior to start of study treatment; any number of prior therapies is permitted
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 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject. DLBCL Dose Expansion Arm:
1 to 2 prior therapies
Excluded previous therapies and medications:
At least 14 days between ibrutinib initiation and last cancer therapy; any number of prior cancer therapies is permitted; patients otherwise fit for blood or marrow transplantation (BMT) should receive second-line chemotherapy before considering enrollment
Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy
For Phase Ib, there is no restriction on the number of prior therapies for recurrent or metastatic disease
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.
< 28 days for any antibodies or biological therapies
Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.
Use of antineoplastic therapies within 21 days before day 1.
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 3 weeks of scheduled dosing day 1.
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 ? 3 weeks before Visit 2
No limitations on prior systemic or intrathecal therapies
Subject has not discontinued all previous systemic therapies for cancer including chemotherapy, immunotherapy, or biological therapies for at least 14 days prior to the initiation of ASP4132.
Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
Being treated with other anti-cancer therapies (approved or investigational)
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Co-administration of anti-cancer therapies other than those administered in this study
Received and failed all known effective therapies for their disease;
Anticipated or ongoing administration of anti-cancer therapies other than those administrated in this study
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
Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:
Received prior therapies including:
Less than 4 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 1
6-60 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
No limit on number of prior therapies
Have received more than 2 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.
Any number of prior therapies are allowed
Completed treatment for breast cancer (except hormonal therapies) within 12 months.
Subject has not started any new systemic immunosuppressive therapies within 2 weeks prior to enrollment
Failure of previous HCV therapies
Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
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
Has undergone ? 2 prior standard therapies
There is no limit to the number of prior therapies