Received systemic anticancer therapy or an investigational agent <2 weeks prior to Day 1 (washout from prior immune based anticancer therapy is 4 weeks). In addition, the first dose of study treatment should not occur before a period ?5 half-lives of the investigational agent has elapsed.
Receipt of systemic anticancer therapy, including investigational agents, within 5 times the agent's elimination half-life of starting study treatment
Prior anticancer systemic therapy
Receipt of any other systemic anticancer therapy with the exception of hormonal therapy for a hormonally sensitive (e.g. breast or prostate) cancer (for treatment phase)
Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose.
Ongoing treatment with an anticancer agent.
Research participants receiving any other anticancer or investigational drug therapy
Systemic therapy (standard or an investigational or biological anticancer agent)
Treatment with anticancer/investigational drugs, therapy ? 4 weeks prior to first dose of SC-002
Ongoing treatment with an anticancer agent not contemplated in this protocol.
Received systemic anticancer therapy within the previous 21 days
Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days before the first dose of the IMP. Hormonal therapy may be administered up to 7 days prior to the first dose of the IMP.
Received prior anticancer therapy within 21 days of first dose
Patients receiving any other anticancer or investigational drug therapy
Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for advanced NSCLC used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry.
Patients who received any of the following within the 14 days before initiating study treatment: major surgery, radiation therapy, and/or systemic therapy (standard or an investigational or biological anticancer agent).
Treatment with any anticancer therapy
Anticancer chemotherapy or immunotherapy during the study or within 5-halflives prior to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within 6 weeks before starting to receive study treatment or within 6 weeks of pre-treatment biopsy for biomarker (p-ERK1/2) studies
Patients who received any systemic anticancer therapy within 2 weeks before randomization.
STRATUM A: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
STRATUM B: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
STRATUM C: Participants must have received their last dose of anticancer therapy (including experimental) at least 4 weeks prior to study enrollment
Immunotherapy and/or investigational anticancer therapy with agents including mAbs : ?4 weeks
Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.
Concomitant use of any anticancer therapy or use of any investigational agent(s).
Receiving any anticancer therapy for biliary tract cancer =< 21 days prior to registration
The subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer, localized prostate cancer on active surveillance, or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years i.e., while the subject may be taking study treatment
Receipt of systemic anticancer therapy, including investigational agents, within 28 days prior to study treatment (Note: If anticancer therapy was given within 28 days prior to starting study treatment, patients are not excluded if ? 5 times the elimination half-life of the drug has elapsed.)
Patients who are actively receiving any other anticancer therapy
Any prior anticancer therapy for this diagnosis
Patients who are receiving any other anticancer agents.
Receipt of anticancer chemotherapy within 4 weeks before the administration of study drug
Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug
Patients who are receiving any other anticancer therapy
Any anticancer therapy or investigational agent within prior 3 weeks.
Systemic anticancer therapy within 21 days of the first dose of study drug\r\n* All adverse events from prior systemic therapy must have either stabilized or returned to baseline
Any investigational anticancer therapy received within 28 days prior to the first dose of durvalumab and tremelimumab
Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids.
Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry
Any prior anticancer therapy
No previous anticancer therapy (radiation therapy or chemotherapy) other than use of corticosteroids
No previous anticancer therapy (radiation therapy or chemotherapy) other than the use of corticosteroids
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment
Receipt of a large molecule anticancer agent (e.g., antibody), including an investigational anticancer antibody, within 28 days of starting study treatment
Patient is receiving concomitant standard and/or investigational anticancer therapy; local palliative radiotherapy is permissible upon discussion with the principal investigator
Treatment for malignancy with anticancer therapy, including cytotoxic agents, hormonal agents, or immunotherapy, within 5 years of enrollment
Patients who are receiving any other anticancer or investigational drug therapy are not eligible
Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
Anticancer Agents: participants who are currently receiving other anticancer agents
Any systemic anticancer therapy within 3 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, or anticancer immunotherapies, a washout period of 6 weeks is required. For patients in Cohort 2, this does not apply to the most recently received hormone therapy.
?3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-neoplastic investigational agents
Received prior systemic anticancer treatment (chemotherapy, targeted therapies including kinase inhibitors, antibodies, etc) less than 5 half-lives before the first dose of study drug or radiotherapy within 30 days; toxicity of the anticancer treatment must have recovered to grade 1 or less.
Need for other anticancer treatment
Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or treatment with any anticancer medications or investigational drugs within the protocol-defined intervals.
Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization
Anticancer therapy within 14 days of first G1T48 dose or within 28 days for antibody-based therapy
Investigational agent, anticancer therapy, or major surgery within 14 days (2 weeks) prior to C1D1
Any non-investigational anticancer therapy within prior 2 weeks
Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies
Not currently receiving any anticancer therapy
The subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years i.e., while the subject may be taking study treatment. However, subjects with low-risk prostate cancer, e.g.:
Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).
No other current active malignancy requiring anticancer therapy.
Receipt of anticancer medications or investigational drugs within protocol-specified intervals
Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
A minimum of 1 week since the last dose of prior therapy (a minimum of 4 weeks since anticancer immune therapy or bevacizumab +/- interferon).
Patients who received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration
Any type of anticancer agent (including investigational) within 2 weeks before randomization.
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
Concomitant use of any other investigational or anticancer agent(s).
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment
Receipt of systemic anticancer therapy, including investigational agents, within 28 days of starting study treatment. If anticancer therapy was given within 28 days of starting study treatment, patients may be included if 5 times the elimination half-life of the drug has passed. a biologic anticancer agent (e.g., antibody), including an investigational anticancer antibody, within 28 days of starting study treatment
Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
Completion of all prior anticancer therapy before first ACP-196 dose.
Received any anticancer medication or therapy in the 21 days prior to study Day 1
Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration.
Systemic treatment with anticancer therapy within 3 weeks before study drug treatment
not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
The subject has received chemotherapy, immunotherapy, or any other systemic anticancer therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days prior to the Day 1 visit.
Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment or receipt of a biologic anticancer agent (e.g., antibody) within 28 days of starting study treatment.
Participants who have received any anticancer treatment within 3 weeks or any investigational agent within 30 days before the first dose of study drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.
Receipt of anticancer therapy:
Prior anticancer or investigational drug treatment within the following windows:
Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration.
Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.
Receipt of anticancer medications or investigational drugs within the Protocol-defined intervals before the first administration of study drug.
The patient has received treatment with an investigational systemic anticancer agent within 14 days prior to study therapy administration.
Is receiving other concomitant anticancer treatment
Patients who are receiving any other investigation agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration
Subject has received chemotherapy, immunotherapy or any other systemic anticancer therapy (including sorafenib) or any other investigational drug within 14 days prior to the Day 1 visit.
Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment;
Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating esophagogastric cancer; last prior therapy must have been completed at least 2 weeks (14 days) prior to starting nintedanib
Receipt of anticancer therapy within 28 days prior to the first dose of Investigational Product
Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment
Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
Received systemic anticancer therapy or radiation therapy within the previous 14 days
Subjects who received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration.
Prior mifepristone use for anticancer therapy is not allowed
Systemic chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy intended to treat underlying malignancy, within 3 weeks before the first dose or 6 weeks for antibody therapy
Radiotherapy or systemic therapy (standard or an investigational or biologic anticancer agent) within 14 days of initiation of study drug treatment
Patients who are receiving any other anticancer therapy
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation; previous systemic treatment is allowed with a 2 week washout period prior to registration
Subjects may not be receiving any other standard or investigational anticancer agents, with the exception of hormonal therapy
Must have received at least one prior systemic anticancer therapy for NSCLC
Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
No expectation of further effects of prior anticancer therapy
Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol
Currently receiving anticancer therapy
Anticancer chemotherapy or immunotherapy: Anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints
Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed.
Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
Other concomitant anticancer treatment
Patients who are receiving any other investigational agents for anticancer treatment within 3 weeks of starting study medication
Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
Active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. Concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)
Previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. Hormonal therapy and bone metastases treatment (example, bisphosphonates, denosumab, etc) are not considered forms of systemic anticancer therapy.
Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
Recent therapy with any active anticancer agent within 4 weeks of the 1st dose of the study drugs
Systemic anticancer therapy within 4 weeks of study entry, except for subjects with anaplastic/undifferentiated thyroid cancer who may be enrolled immediately after discontinuation of previous therapy
Received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration
Has received treatment with any systemic anticancer therapy, wide-field radiation, or experimental agent within 4 weeks of receiving cyclophosphamide on Day -3, with the exception of anticancer hormonal therapy, which may not be given within 2 weeks of receiving cyclophosphamide on Day -3. All residual toxicity related to prior anticancer therapies (excluding vitiligo, endocrinopathies on stable replacement therapy, alopecia and Grade 2 fatigue) must resolve to Grade 1 severity or less or return to baseline prior to receipt of study treatment.
Receipt of anticancer therapy:
Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug
Systemic anticancer therapy within 28 days
Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
Any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection
Anticipated ongoing concomitant anticancer therapy during the study.
Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
Currently receiving anticancer therapy or have received anticancer therapy within the past 28 days or 5 half-lives of the anticancer therapy
Anticancer chemotherapy, experimental cancer therapy, or cancer immunotherapy within 4 weeks prior to first dose study drug. Anticancer therapy is defined as any agent or combination of agents with clinically proven anti tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints.
Receipt of other anticancer therapy within 2 - 6 weeks, depending on the treatment
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
Need for concomitant anticancer therapy (surgery, radiation therapy, chemotherapy, immunotherapy, radiofrequency ablation) or other investigational agents during the study treatment period.
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, low dose cytarabine and intrathecal chemotherapy
Participated in a prior anticancer investigational study =< 30 days prior to enrollment, or =< 5 half-lives of the anticancer investigational product, whichever is longer (treatment with somatostatin analogue [SSTa] while on dovitinib is allowed provided patient’s tumor has progressed on therapy prior to initiating dovitinib treatment)
Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
Toxicity from previous anticancer treatment.
Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of durvalumab and IPH2201
Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
Patients who have declined further anticancer therapy will be excluded
Use of other anticancer therapy within 15 days before the first dose of M3541 administration and should not be within the \at risk follow-up period\ for that specific anticancer therapy. The use of any investigational agent is not allowed within 28 days before the first dose of M3541
On any new anticancer therapy (GnRH analog allowed) while on the study
Treatment with anticancer chemotherapy or biologic therapy or with an experimental anticancer agent within 28 days of the initial dose of study drug.
Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents; <=8 weeks for cell-based therapy or anti-tumor vaccine), or not recovered from the reversible effects of prior anticancer therapy.
Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
Participants who have received any anticancer treatment within 21 days or any investigational agent within 30 days (or 5 half-lives) prior to the first dose of study drug and should have recovered from any toxicity related to previous anticancer treatment. This does not apply to the use of TSH suppressive thyroid hormone therapy.
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
Receipt of systemic anticancer therapy, including investigational agents, within 28 days of starting study treatment. If anticancer therapy was given within 28 days of starting study treatment, patients may be included if 5 times the elimination half-life of the drug has passed