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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Ph I Dose Escalation & Cohort Expansion Study of TSR-042 in Pts w/ Advanced Solid Tumors

    Protocol: OSU-16293

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Ph 1, BXQ-350 as a Single Agent by IV w/ Advanced Solid Tumors and Recurrent High-Grade Gliomas

    Protocol: OSU-16182

    Principal Investigator: Vinay K Puduvalli, MD

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  • open for enrollment

    Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

    Protocol: OSU-15172

    Eligibility:

    Inclusion Criteria:

    Histologically- or cytologically-confirmed diagnosis of locally advanced or

    metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

    Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a

    gene rearrangement of interest may be eligible provided they meet all other

    inclusion/exclusion criteria

    For patients enrolled via local molecular testing, an archival or fresh tumor tissue

    (unless medically contraindicated) is required to be submitted for independent

    central molecular testing at Ignyta's CLIA laboratory post-enrollment

    Measurable or evaluable disease

    Patients with CNS involvement, including leptomeningeal carcinomatosis, which is

    either asymptomatic or previously-treated and controlled, are allowed

    Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,

    or ALK inhibitors in patients who have tumors that harbor those respective gene

    rearrangements)

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior

    chemotherapy or small molecule targeted therapy

    At least 4 weeks must have elapsed since completion of antibody-directed therapy

    Prior radiotherapy is allowed if more than 14 days have elapsed since the end of

    treatment

    Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life

    expectancy of 4 weeks

    Adequate organ function as defined per protocol

    Ability to swallow entrectinib intact

    Other protocol specified criteria

    Exclusion Criteria:

    Current participation in another therapeutic clinical trial

    Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in

    patients who have tumors that harbor those respective gene rearrangements

    Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged

    NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are

    prohibited.

    History of other previous cancer that would interfere with the determination of

    safety or efficacy

    Incomplete recovery from any surgery

    History of non-pharmacologically induced prolonged QTc interval

    History of additional risk factors for torsade de pointes

    Peripheral neuropathy Grade ≥ 2

    Known active infections

    Active gastrointestinal disease or other malabsorption syndromes

    Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase

    inhibitor-induced pneumonitis

    Other protocol specified criteria

    Principal Investigator: Gregory A Otterson, MD

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  • open for enrollment

    A Randomized Phase 2 Trial of Cisplatin/Gemcitabine w/ or w/o VX-970 in Meta Urothelial Carcinoma

    Protocol: OSU-17029

    Principal Investigator: Amir Mortazavi, MD

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  • open for enrollment

    Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

    Protocol: OSU-16090

    Eligibility:

    Inclusion Criteria:

    Histological proof of muscle-invasive transitional cell carcinoma of the bladder

    (stage II-IIIb). Patients with evidence of metastatic nodal disease to the obuturator

    or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of

    fixation of the pelvic sidewall are not eligible.

    Patient must have residual visible tumor following TURBT measuring no less than 3-cm.

    Adequate laboratory parameters.

    Subjects must be willing to undergo a cystoscopy on study for investigational product

    removal.

    Eligible for and willing to undergo radical cystectomy per the attending urologist.

    Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by

    the attending medical oncologist.

    Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy

    who refuse this therapeutic option and understand the risks and benefits of doing so.

    Prior radiation therapy is allowed provided that no radiation therapy was

    administered to the urinary bladder.

    Written informed consent and HIPAA authorization for release of personal health

    information.

    Age > 18 years at the time of consent.

    Exclusion Criteria:

    A history of prior malignancy, however the following are allowed:

    1. non-muscle invasive transitional cell carcinoma

    2. adequately treated basal cell or squamous cell skin cancer

    3. in situ cervical cancer

    4. Gleason < grade 7 prostate cancers

    5. Other cancer for which the subject has been disease-free for at least 5 years

    Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other

    prior systemic chemotherapy for a non-urothelial carcinoma must have been completed >

    5 years prior to initiation of study.

    Previous exposure to gemcitabine instillations.

    Currently receiving other intravesical chemotherapy.

    Concurrent clinically significant infections as determined by the treating

    investigator.

    Presence of any bladder or urethral anatomic feature that in the opinion of the

    investigator may prevent the safe placement, indwelling use or removal of GemRIS.

    Documented history of vesicoureteral reflux or the presence of an indwelling ureteral

    stent or nephrostomy tube at the time of screening.

    Pelvic radiotherapy administered within less than 6 months prior to enrollment.

    Subjects who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no

    cystoscopic evidence or symptoms of radiation cystitis.

    Bladder Post-Void Residual Volume (PVR) of > 250-mL.

    Active, uncontrolled urogenital bacterial, viral or fungal infections, including

    urinary tract infection. Subject must not have a UTI within one month prior to GemRIS

    Insertion Visit, Study Day 0. Skin/nail fungal infections are not exclusionary.

    Subjects with active shingles (varicella zoster infection) will be excluded from the

    study.

    History or presence of any significant cardiovascular, pulmonary, hepatic, renal,

    gastrointestinal, gynecological, endocrine, immunological, dermatological,

    neurological or psychiatric disease or disorder that, in the opinion of the

    investigator, contraindicates participation.

    History of diagnosis of neurogenic bladder.

    Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors,

    within 2 weeks of Study Day 0.

    Difficulty providing blood samples.

    Unwilling or unable to provide informed consent or comply with the requirements of

    this protocol, including the presence of any condition (physical, mental or social)

    that is likely to affect the subject's return for scheduled visits and follow-up.

    Other unspecified reasons that, in the opinion of the investigator or TARIS, make the

    subject unsuitable for enrollment.

    Principal Investigator: Kamal S Pohar, MD

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  • open for enrollment

    A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors

    Protocol: OSU-16195

    Eligibility:

    Inclusion Criteria:

    For Dose Escalation:

    Subjects with any previously treated advanced (metastatic or refractory) solid

    tumor

    For Cohort Expansion:

    Subjects must have a previously treated advanced solid tumor to be eligible

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

    Women of child-bearing potential and men must use an acceptable method of

    contraception during treatment and for 23 weeks after treatment for women and 31

    weeks for men

    Exclusion Criteria:

    Known central nervous system metastases or central nervous system as the only source

    of disease

    Other concomitant malignancies (with some exceptions per protocol)

    Active, known or suspected autoimmune disease

    Uncontrolled or significant cardiovascular disease

    History of active or chronic hepatitis (e.g. Hep B or C)

    Impaired liver or bone marrow function

    Major surgery less than 1 month before start of the study

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    A Phase III Study of Atezolizumab Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]

    Protocol: OSU-16078

    Eligibility:

    Inclusion Criteria:

    Age >/= 18 years

    Histologically or cytologically confirmed muscle-invasive TCC of the bladder

    (excluding TCC of renal pelvis, ureters, or urethra) which is PD-L1 positive

    For patients who have not received prior neoadjuvant chemotherapy, refusal of or

    ineligibility for cisplatin-based adjuvant chemotherapy

    Representative tumor specimens as specified by the protocol

    Absence of residual disease and absence of metastasis, as confirmed by a negative

    baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the

    pelvis, abdomen, and chest no more than 6 weeks prior to randomization

    Full recovery from cystectomy and randomization within 12 weeks following surgery

    Eastern Cooperative Oncology Group (ECOG) performance status of </= 2

    Life expectancy >/= 12 weeks

    Adequate hematologic and end-organ function

    For women who are not postmenopausal or surgically sterile: agreement to remain

    abstinent or use single or combined contraceptive methods that result in a failure

    rate of <1% per year during the treatment period and for at least 90 days after the

    last dose of study drug

    Exclusion Criteria:

    Any approved anti-cancer therapy within 3 weeks prior to initiation of study

    treatment

    Adjuvant chemotherapy or radiation therapy for urothelial carcinoma (UC) following

    cystectomy

    Treatment with any other investigational agent or participation in another clinical

    trial with therapeutic intent within 28 days prior to enrollment

    Malignancies other than UC within 5 years prior to Cycle 1, Day 1

    Pregnancy or breastfeeding

    Significant cardiovascular disease

    Severe infections within 4 weeks prior to randomization

    Major surgical procedure other than for diagnosis within 4 weeks prior to

    randomization

    History of severe allergic, anaphylactic, or other hypersensitivity reactions to

    chimeric or humanized antibodies or fusion proteins; known hypersensitivity or

    allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any

    component of the MPDL3280A formulation

    History of autoimmune disease

    Prior allogeneic stem cell or solid organ transplant

    History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced

    pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening

    chest CT scan

    Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis

    Administration of a live, attenuated vaccine within 4 weeks prior to randomization

    Prior treatment with CD137 agonists or immune checkpoint blockade therapies,

    including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

    Principal Investigator: Amir Mortazavi, MD

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