Subjects who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Prior bisphosphonate use is permitted
Bisphosphonates will not be allowed on the study while the participant is receiving sotatercept; prior bisphosphonate use is allowed
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Have initiated treatment with bisphosphonates less than 30 days prior to study registration; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to study registration
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study; patients wanting to initiate bisphosphonate therapy may do so
Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Patients who are currently receiving bisphosphonate derivatives are not eligible
Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Initiating bisphosphonate, or RANKL antibody therapy or adjusting the dose/regimen within 30 days prior to cycle 1 day 1 is prohibited; patients on a stable bisphosphonate regimen are eligible and may continue
Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment
Use of bisphosphonate therapy for osteoporosis will be allowed if started prior to study enrollment
Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)
Has received prior bisphosphonate therapy
Treatment within the past two years with a bisphosphonate or a Rank ligand inhibitor
Concurrent bisphosphonate therapy is not excluded, however patients should not start bisphosphonate therapy while on this study; those patients already receiving bisphosphonate therapy should continue at the same dosing and schedule as prior to study entry
Concurrent bisphosphonate or receptor activator of nuclear factor kappa-B (RANK)-ligand directed therapy for prevention of skeletal related events or treatment of osteoporosis is allowed
Have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228); concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Initiation or discontinuation of bisphosponate use within past 14 days\r\n* Continuation of use is allowed but patients must continue bisphosphonate throughout the treatment and follow up period until disease progression
Active intravenous (IV) bisphosphonate use in the last 3 months
Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine, or St. John’s wort is not permitted; concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; bisphosphonate therapy may not be initiated after study entry
Concurrent use of bisphosphonates is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted
Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa-? ligand inhibitor) must be on stable doses for ?4 weeks prior to first dose of study therapy
Participants receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to treatment allocation.
If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
Prior or ongoing bisphosphonate (e.g,. zoledronic acid) or RANKL inhibitor (e.g. denosumab) use is NOT allowed except when used solely for osteoporosis and strictly per guidelines for that indication. Bisphosphonate or RANKL inhibitor cannot be initiated for any indication during protocol specified therapy without consent of the sponsor-investigator of the study.
No current anti-myeloma bisphosphonate therapy (however, prior bisphosphonates and/or bisphosphonate therapy due to osteoporosis is allowed)
Patients may have initiated bisphosphonate therapy prior to start of protocol therapy; bisphosphonate therapy may continue during protocol treatment; such patients will have bone lesions considered evaluable for progression
Current or previous chemotherapy or bisphosphonate therapy is permissible
Patient can be receiving bisphosphonate therapy per the treating oncologist's discretion.
Patients may have initiated bisphosphonate therapy prior to start of protocol therapy; bisphosphonate therapy may continue during protocol treatment; such patients will have bone lesions considered evaluable for progression
Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to the first infusion with ipilimumab
Bisphosphonate or receptor activated of nuclear factor kappa-B (RANK) ligand inhibitor therapy for bone metastases is allowed; prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted
Patients may receive a bisphosphonate.
Patients may not initiate bisphosphonate therapy while receiving treatment on this study; patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Prior or current IV bisphosphonate administration
Bisphosphonate therapy currently or within the past 12 months
Concurrent bisphosphonate treatment
No radiation therapy to targeted (most painful) lesion in the past two weeks Bisphosphonate intake should remain stable throughout the study duration.
Patients undergoing bisphosphonate therapy are allowed
More than 1 previous dose of IV bisphosphonate administration
Patients with current or previous bisphosphonate therapy
Patients who have initiated treatment with bisphosphonates less than 30 days prior to the first administration of MLN0128 (TAK-228) are ineligible; concurrent bisphosphonate use is only allowed if the bisphosphonate was initiated at least 30 days prior to the first administration of MLN0128 (TAK-228)
Patients currently using oral bisphosphonate therapy
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registration
Patients may be treated with bone modifying agents such as bisphosphonates or RANK-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g., denosumab) who cannot discontinue it before treatment with atezolizumab
Patients must not require treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Denosumab or zoledronic acid are allowed
Is expected to require any other form of anti-cancer therapy while in the trial. Zoledronic acid or denosumab as supportive care for bone metastases will be allowed if started prior to study enrollment
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Bone metastases with prior history of pathologic fracture, lytic lesions requiring an orthopedic intervention, or not receiving bisphosphonates or denosumab
Radiation therapy, chemotherapy, immunotherapy, investigational therapy or corticosteroid use within 2 weeks of or after eligibility-defining bone marrow biopsy. Bisphosphonates and denosumab are permitted if subject has been receiving for at least 90 days
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Initiation of bisphosphonate/denosumab therapy during the study; subjects on stable doses of bisphosphonates or the tumor necrosis factor receptor superfamily member 11a, subfamily L (RANK-L) inhibitor, denosumab, which have been started no less than 4 weeks prior to registration, may continue on this medication
Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
The use of raloxifene, denosumab, or bisphosphonates for bone health is allowed
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Concurrent treatment with bisphosphonates or denosumab is required
Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation; bisphosphonates or denosumab are allowed
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to denosumab are not eligible (i.e. same class of drugs) (Note: prior bisphosphonates are allowed; patients could have received bisphosphonates or be bisphosphonate-naive; patients who were previously on bisphosphonates can be enrolled in the study, as long as they have a wash-out period of 2 weeks prior to registration)
Subject has started treatment with denosumab < 1 month prior to study entry; subjects are allowed to be on bisphosphonates or denosumab provided they are on a stable dose for >= 4 weeks before administration of study drug
Treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) within 2 weeks of first study dose
Prior chemotherapy for castration resistant disease; chemotherapy given in the hormone-sensitive setting is permissible if stopped at least 4 weeks prior to registration\r\n* Note: Patients can receive a stable dose of bisphosphonates for bone metastases, including zoledronic acid, or denosumab before and during the study as deemed appropriate by the treating physician
UROTHELIAL CARCINOMA EXPANSION COHORT: Bisphosphonates and denosumab are permitted if on a stable dose for >= 4 weeks
INCLUSION CRITERIA FOR TNBC: Patients may receive agents to protect against skeletal related complications such as zoledronic acid or denosumab
Patients who are or are not receiving bisphosphonates or denosumab are eligible; bisphosphonates or denosumab should not be initiated after registration and during active treatment
If a subject is currently receiving bisphosphonates or denosumab, the subject must have received the bisphosphonates or denosumab for at least four weeks before starting study treatment. (Initiation of bisphosphonates or denosumab during the study may be allowed provided the subject completes the first cycle of treatment without any DLT and the Investigator rules out tumor progression.)
Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
Patients requiring treatment with a receptor activator of nuclear factor kappa-? ligand (RANKL) inhibitor (e.g., denosumab) who cannot discontinue it before initiation of study treatment
Bisphosphonates and/or denosumab are allowed
Concomitant use of bisphosphonates, receptor activator of nuclear factor kappa-? ligand (RANKL) antibody, and ovarian suppression is allowed
Patients receiving bone loss prevention treatment with bone-modifying agents (e.g. denosumab, zoledronic acid) must be on stable doses for at least 4 weeks prior to randomization
Treatment with bisphosphonates or denosumab is allowed and recommended per the standard of care
Prior administration of denosumab
Clinically significant hypersensitivity to denosumab or any components of denosumab 120 mg
Treatment with denosumab (or other receptor activator of nuclear factor kappa-B ligand [RANKL] inhibitor) 4 weeks before the first dose and for 10 weeks after the last dose of atezolizumab
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
The subject has started treatment with drugs used to control loss of bone mass (eg, bisphosphonates or denosumab) within 4 weeks prior to the first dose of study treatment
Subject that started a bone modifying agent (e.g. bisphosphonates, denosumab) ? 28 days of study drug initiation (note: ongoing bone modifying agents administered > 28 days are allowed).
Participants on bisphosphonates or receptor activator of nuclear factor kappa B (RANK) ligand inhibitors may continue receiving therapy during study treatment
Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and/or during the trial, unless there is a contraindication or subject intolerance to these therapies. For patients who are normocalcemic, therapy can be initiated at the time the patient initiates study drug
Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis
Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
Oral examination and appropriate preventive dentistry will be performed prior to the initiation of denosumab therapy.
History of hypersensitivity to denosumab.
Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
Patients who have previously received denosumab
Patients receiving bisphosphonates
Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
Plans to begin bisphosphonates or denosumab after registration or began therapy regiment =< 30 days from registration\r\n* NOTE: patients on a stable dose of bisphosphonates or denosumab > 30 days prior to registration are acceptable
Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 days prior to randomization
Patients currently receiving bone loss prevention treatment (e.g. bisphosphonates, denosumab, etc.) must be on a stable dose for at least 4 weeks prior to starting study treatment
Bisphosphonate (e.g. zoledronic acid) and receptor activator of nuclear transcription factor kappa-B (NF-kappaB) ligand (RANKL) inhibitor (e.g. denosumab) use for bone metastasis is permitted
At least a 4 week interval from previous prostate cancer treatment other than LHRH agonist/antagonist therapy, bisphosphonates, denosumab to the start of protocol therapy
Participants receiving bisphosphonates therapy or denosumab can be maintained on this therapy; if participants have not started bisphosphonates, it is recommended that they start treatment after the first (optional) biopsy
Zometa or denosumab can be continued as per standard of care as long as started before the study treatment is started
At least a 4 week interval from previous prostate cancer treatment other than LHRH agonist/antagonist therapy, bisphosphonates, or denosumab to enrollment
Participants receiving bisphosphonates therapy or denosumab can be maintained on this therapy; if participants have not started bisphosphonates or denosumab, it is recommended that they start treatment after the first biopsy
Participants may not be receiving any other investigational agents; concurrent treatment with bisphosphonates or denosumab is allowed
Patients on stable doses of bisphosphonates or denosumab which have been started prior to registration may continue on this medication, patients who are not on bisphosphonates or denosumab are eligible as long as they initiate therapy prior to registration
Any experimental drug while on this study; however, concomitant bone targeted therapy (bisphosphonates or the anti-tumor necrosis factor receptor superfamily, member 11a, NFKB activator [RANK] ligand denosumab) is allowed
Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
For patients receiving bone-loss prevention treatment (e.g., bisphosphonates or denosumab), the patient must be on stable dose ?4 weeks prior to start of study drug.
Patients may or may not have started bisphosphonates
Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and during the trial, unless there is a contraindication or subject intolerance to these therapies
Currently receiving anti-cancer therapy. Exceptions: Zoledronic acid and denosumab to treat bone metastasis are allowed.
Prior administration of denosumab
Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ? 28 days prior to Day 1 of Cycle 1.
Bisphosphonates and denosumab are permitted, if on a stable dose for >= 4 weeks
Patient may receive bisphosphonates/denosumab for the palliation of bone metastases
Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ?28 days prior to day 1 of cycle 1.
Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.
Prior and ongoing zoledronic acid or denosumab therapy is allowed
Bisphosphonates/tumor necrosis factor receptor super family, member 11a (RANK)-ligand inhibitor allowed if started prior to study treatment
Patients who have not discontinued all prior medical therapy for breast cancer (with the exception of bisphosphonates or denosumab) at least 21 days prior to first dose of orteronel; this includes patients who have received other investigational agents within 21 days prior to the first dose of orteronel
Prior and/or planned concomitant medical therapy during the study period (through day 360 post-HCT) with other bisphosphonates, denosumab, or teriparatide
Be diagnosed with bone metastases subsequent to breast (female subjects only) or prostate carcinoma, and will have received zoledronate or denosumab therapy for at least 3 months at the time of enrollment
Prior administration of denosumab
Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy and may continue throughout duration of study
Participants must be willing to take supplemental oral calcium 1000 mg and vitamin D3 1000 IU daily for six months (which will be supplied by the research study) after receiving denosumab treatment or no treatment
History of allergic reactions or hypersensitivity attributed to denosumab or any components of denosumab or compounds of similar chemical or biologic composition to denosumab, such as other RANKL inhibitors
Subjects must be on therapy with bisphosphonates or denosumab for at least 1 month before start of study treatment.
Patients on stable doses of bisphosphonates or the receptor activator of RANK-L inhibitor, denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/denosumab therapy during the study
Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or denosumab)