Prior treatment with nab-P for the treatment of metastatic disease.
Patient must not have had prior treatment with paclitaxel or nab-paclitaxel
Patients for whom paclitaxel (or nab-paclitaxel) is being used in the curative setting, either adjuvant or neoadjuvant, and patients who would receive paclitaxel (or nab-paclitaxel) as first line therapy in a tumor type in which paclitaxel (or nab-paclitaxel) has a proven survival benefit for metastatic disease
Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim
Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator.
For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for days after the final dose of nab-paclitaxel and gemcitabine or for days for female patients and for days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered.
Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for weeks after the last dose of napabucasin or while undergoing treatment with nab-paclitaxel and gemcitabine and for days after the last dose of nab-paclitaxel and gemcitabine.
Has a known sensitivity to any component of carboplatin or paclitaxel or nab-paclitaxel.
Patients with advanced or metastatic solid tumors who have disease progression after treatment with available therapies and for whom nab-paclitaxel treatment is appropriate.
Participants who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or to nab-paclitaxel and any of the excipients
Prior treatment with gemcitabine and/or nab-paclitaxel in the adjuvant setting is allowed, provided at least months have elapsed since completion of the last dose and no lingering toxicities are present.
History of allergic reactions or hypersensitivity to the study drugs (hydroxychloroquine, gemcitabine, nab-paclitaxel, avelumab)
Completion of at least months, but no more than months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably with a washout period no longer than weeks.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to nab-paclitaxel or anti-PD/PDL or human albumin
Prior treatment with nab-paclitaxel (abraxane)
Received prior treatment with nab-paclitaxel.
Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
No more than one prior line of non-gemcitabine/nab-paclitaxel containing systemic therapy for metastatic/locally advanced pancreatic cancer
Known hypersensitivity to nintedanib, gemcitabine and nab-Paclitaxel, peanut or soy or any other trial drug, their excipients
Completion of at least months, but no more than months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within - weeks but no longer than weeks
FOR PARTICIPANTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B SINGLE AGENT LEAD-IN)
No treatment with paclitaxel or nab-paclitaxel within months prior to initiation of study therapy
FOR PARTICIPANTS WHO WILL NOT RECEIVE NAB-PACLITAXEL (ARM B SINGLE AGENT LEAD-IN ONLY)
EXCLUSION CRITERIA SPECIFIC TO PATIENTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B SINGLE AGENT LEAD-IN)
Participants with contra-indication and/or history of severe hypersensitivity reactions to nab-paclitaxel
Subjects must not have received paclitaxel or nab-paclitaxel within months prior to initiation of study therapy
Participants with contra-indication and/or history of severe hypersensitivity reactions to nab-paclitaxel
The patient must be eligible for standard of care treatment with gemcitabine +nab-paclitaxel.
Known hypersensitivity to any of the components of atezolizumab or nab-paclitaxel
ARM A COHORT : Patients must not have prior nab-paclitaxel exposure
Allocated to receive Gemcitabine + nab-Paclitaxel as first line treatment.
Known hypersensitivity to nab-paclitaxel or any of its excipients
For gynecologic cancer cohort only recurrent or progressive disease within days of the last dose of weekly paclitaxel or nab-paclitaxel
Subject has previously been treated with nab-paclitaxel\t\r\n* NOTE: Subjects who have had previous treatment with nab-paclitaxel will NOT be excluded if given in the adjuvant or neoadjuvant setting\r\n* Only in the metastatic setting, will subjects previously treated with nab-paclitaxel be excluded from this trial; exceptions may be made for subjects who discontinued treatment with a previous nab-paclitaxel inhibitor for reasons other than progression and as long as it has been > months since discontinuation of the previous nab-paclitaxel; this exception will require prior approval from the study principal investigator (PI) at University of Kansas Medical Center (KUMC)
Subject has a known hypersensitivity to any of the excipients of nab-paclitaxel or BYL/alpelisib
PHASE II: Patients must NOT have received gemcitabine or nab-paclitaxel in a metastatic setting
Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)
History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. . Currently enrolled in any other clinical protocol or investigational trial that involved administration of experimental therapy and/or therapeutic devices.
nab-Paclitaxel and Nivolumab: Subjects must have received prior systemic chemotherapy regimen for locally advanced or metastatic disease.
nab-Paclitaxel + Nivolumab and nab-paclitaxel, Gemcitabine and Nivolumab: Subjects must have received no previous systemic chemotherapy or investigational therapy for the treatment of pancreatic adenocarcinoma, including neo-adjuvant or adjuvant therapy, with the exception of prior treatment administered as a radiosensitizer concomitant with radiotherapy in the adjuvant setting. In this case, ? months must have elapsed since completion of the last dose and no lingering toxicities may be present. Initial diagnosis of metastatic disease must have occurred ? weeks prior to randomization in the study.
Suitable candidate for single agent nab-paclitaxel as assessed by the investigator.
SUB-PROTOCOL AIM A: Any of the following treatments:\r\n* Chemotherapy within weeks before treatment with nab-rapamycin\r\n* Hormonal therapy within weeks before treatment with nab-rapamycin (with the exception of leuprolide, degarelix, or goserelin)\r\n* Immunotherapy within weeks before treatment with nab-rapamycin\r\n* Radiotherapy within weeks before treatment with nab-rapamycin \r\n* Treatment with nitrosoureas, mitomycin, or extensive radiotherapy within weeks before treatment with nab-rapamycin\r\n* Immunosuppressive agents within weeks before treatment with nab-rapamycin (except corticosteroids used as antiemetics)\r\n* Use of prior mTOR pathway inhibitor therapy
For dose escalation phase (Phase Ib) or prior lines of chemotherapy for advanced pancreatic cancer. Prior gemcitabine is allowed, however prior nab-paclitaxel is not allowed.
No known hypersensitivity to gemcitabine or nab-paclitaxel
Patients enrolling onto Arm A (Gemcitabine and nab-Paclitaxel) or Arm B (mFOLFIRINOX) are allowed to have up to two prior lines of systemic therapy, with adjuvant therapy counted as one line of therapy as long as disease recurrence occurred > months of last dose of therapy. Prior systemic therapy in the metastatic setting is allowed for as long as the therapy contained BBI in combination with either Gemcitabine and nab-Paclitaxel or mFOLFIRINOX. Toxicities related to prior therapy must have completely resolved (except for alopecia and anemia), or be deemed irreversible.
Patients enrolling onto Arm A (Gemcitabine with nab-Paclitaxel) are allowed to have prior mFOLFIRINOX in combination with BBI in the metastatic setting.
Patients enrolling onto Arm B (mFOLFIRINOX) are allowed to have prior Gemcitabine with nab-Paclitaxel in combination with BBI in the metastatic setting.
Non-pregnant and non-nursing. The effect of nab-paclitaxel and nivolumab on the fetus is unknown.
Prior nab-paclitaxel chemotherapy excluded.
Known hypersensitivity to any of the components of ipilimumab, bevacizumab, or nab-paclitaxel
Prior treatment with nab-paclitaxel.
Patient must not have previously received nab-paclitaxel
History of hypersensitivity to nab-paclitaxel or paclitaxel
Known hypersensitivity to nab-paclitaxel or to gemcitabine or to any of the excipients.
Eligible for treatment with nab-paclitaxel and gemcitabine on Days , , and in -day cycles as standard therapy
Currently or previously treated with conventional chemotherapy, or other agents for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + nab-paclitaxel only)
Known hypersensitivity to nab-paclitaxel (Arm: idelalisib + nab-paclitaxel), their metabolites, or formulation excipients
Patients with contra-indication and/or history of severe hypersensitivity reactions to gemcitabine and/or nab-paclitaxel as mentioned in the locally approved label
Subject has a history of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.
Completion of at least months, but no more than months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, preferably within - weeks but no longer than weeks
History of or suspected allergy to nab-paclitaxel, carboplatin and human albumin or any other platinum-based therapy.
Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel).
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nab-paclitaxel through days after the last dose; men should be advised to not father a child while receiving treatment with nab-paclitaxel; appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator
A history of a severe hypersensitivity reaction to nab-paclitaxel
History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
Prior therapy allowed but, no prior therapy with nab-paclitaxel, paclitaxel, temozolomide, dacarbazine or bevacizumab
Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based resulting in disease progression
The patients previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team
Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components.