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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 1b/II BGB-290 in comb w/ radiation and/or temozolomide w/ recurrent/refractory glioblastoma

    Protocol: OSU-17310

    Principal Investigator: Vinay K Puduvalli, MD

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  • open for enrollment

    Nivolumab and Ipilimumab in Treating Patients with HIV Associated Solid Tumors That are Metastatic or Cannot Be Removed by Surgery

    Protocol: AMC-095

    Eligibility:

    Inclusion Criteria:

    Participants must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; participants with uncontrolled Kaposi sarcoma are permitted (KS must be increasing despite HAART and HIV suppression for greater than or equal to 2 months, or stable KS despite HAART for greater than or equal to 3 months)

    HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant’s relevant medical history and/or current management of HIV infection

    Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration; Note: for participants with Kaposi sarcoma, the following apply: at least five measurable cutaneous KS lesions or any number of lesions with systemic unresectable disease with no previous local radiation, surgical, or intralesional cytotoxic therapy that would prevent response assessment

    Prior therapy for metastatic disease permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least 4 weeks prior to registration

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

    Leukocytes >= 2,000/mm^3

    Absolute neutrophil count >= 1,000/mm^3

    Platelets >= 75,000/mm^3

    Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilbert’s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation and must have a total bilirubin less than 3.0 mg/dL

    Serum lipase and amylase < 1.5 x ULN

    AST (serum glutamic oxaloacetic transaminase [SGOT])/ALT (serum glutamate pyruvate transaminase [SGPT]) =< 3 X ULN

    Creatinine < 1.5 UNL or creatinine clearance (CrCl) > 50 ml/min

    Hemoglobin >= 9 g/dL

    Serum albumin >= 2.8 g/dL

    HIV plasma HIV-1 ribonucleic acid (RNA) below detected limit obtained by Food and Drug Administration (FDA)-approved assays (limit of detection: 75) within 4 weeks prior to registration

    CD4 counts:

    For Stratum 1: CD4+ cell count greater than 200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent

    For Stratum 2: CD4 cell count between 100-200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent

    Expansion Cohort: CD4 cell count for this cohort will be specified once Stratum 1 and Stratum 2 have completed enrollment

    Participants must be purified protein derivative (PPD) negative; PPD positive participants are permitted if prophylaxis has been completed prior to enrollment

    Women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 72 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately

    Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment

    Participants who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV RNA) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided total bilirubin is =< 1.5 x institutional ULN, and AST (SGOT) and ALT (SGPT) must be =< 3 X institutional upper limit of normal, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/mL (if hepatitis B positive) within 2 weeks prior to enrollment

    Ability to understand and to sign a written informed consent document

    Criteria for Solid Tumor Expansion Cohort:

    Inclusion and exclusion criteria for this cohort are the same as above, with the following rule for CD4 count based on tolerability in Phase I; if, participants with lymphocyte T CD4 count between 100-200/mm^3 (Stratum 2) are shown to tolerate treatment in the Phase I dose de-escalation portion at the same dose level as those with CD4 counts > 200/mm^3 (Stratum 1), participants in the expansion cohort with CD4 counts >= 100/mm^3 are permitted; otherwise, only participants with CD4 count > 200/mm^3 will be enrolled in this cohort; the expansion is limited to only participants with Kaposi sarcoma, lung cancer, and anal cancer

    Exclusion Criteria:

    Participants who have received any other investigational agents within the 4 weeks prior to enrollment; concurrent radiation therapy is not permitted, except palliative (limited-field) radiation therapy, if all of the following criteria are met:

    Repeat imaging demonstrates no new sites of bone metastases

    The lesion being considered for palliative radiation is not a target lesion

    Participants with known brain metastases or leptomeningeal metastases must be excluded unless they qualify for enrollment as described below because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; participants with brain metastases are permitted if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks or more after treatment is complete and within 4 weeks prior to the first dose of nivolumab administration

    History of allergic reactions attributed to compounds of similar chemical or biologic composition to ipilimumab, nivolumab, or other agents used in study, or history of severe hypersensitivity reaction to any monoclonal antibody

    Participants should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration; these drugs may interfere with the activity of ipilimumab and nivolumab if administered at the time of the first ipilimumab dose; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if >= 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted; use of anabolic steroids is permitted

    Participants with clinical or radiographic evidence of pancreatitis are excluded

    Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    Participants should be excluded if they have had prior treatment with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), anti-programmed cell death ligand 2 (PD-L2), anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways; prior immune modulating therapy including vaccines may be eligible; prior immune events must be evaluated and the risk for new events which may represent continued sub clinical disease or a new process at previously damaged site or immune potentiation (e.g. ipilimumab followed by IL2 causing bowel perforation, ipilimumab followed by indoleamine 2,3-dioxygenase [IDO] inhibitor resulting in clinical hypophysitis); please keep in mind that inflammatory events may occur weeks to months following the last dose of ipilimumab and possibly nivolumab; assessment of potential effects of prior therapy should include:

    Immune status

    Organ damage

    Risk of autoimmunity

    Immunopotentiation

    The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except =< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs)

    The subject has a primary brain tumor

    Participant has >= grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative)

    Opportunistic infection within the last 3 months

    Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; participants with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and participants with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

    Participants who have had evidence of Clostridium (C.) difficile infection, active or acute diverticulitis, intra-abdominal abscess, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis, which are known risk factors for bowel perforation, should be evaluated for the potential need for additional treatment before coming on study

    Principal Investigator: Robert A Baiocchi, MD, PhD

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  • open for enrollment

    A Pilot Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas

    Protocol: AMC-101

    Principal Investigator: Robert A Baiocchi, MD, PhD

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  • open for enrollment

    Study Ovarian Ca Pts Evaluating Rucaparib and Nivo Rx Following Response Platinum-Based Chemo

    Protocol: OSU-18133

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy

    Protocol: OSU-13211

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically confirmed advanced solid tumor that is

    metastatic or unresectable and for which standard curative or palliative measures do

    not exist or are no longer effective, or for whom regimens containing gemcitabine,

    cisplatin, and/or etoposide might be considered, and with measurable disease

    according to RECIST criteria

    Part C1:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    Measurable disease according to RECIST criteria

    -Part C2:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen

    receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)

    negative breast cancer.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    Hematological and biochemical indices within protocol specified ranges at screening.

    Exclusion Criteria:

    Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or

    chemotherapy during the previous 4 weeks (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    Parts A and B:

    Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.

    (a) History of prior dose reductions or dose interruptions while receiving

    cisplatin or carboplatin due to toxicity from the platinum or intolerance to

    either agent.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Exclusion Criteria:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically confirmed advanced solid tumor that is

    metastatic or unresectable and for which standard curative or palliative measures do

    not exist or are no longer effective, or for whom regimens containing gemcitabine,

    cisplatin, and/or etoposide might be considered, and with measurable disease

    according to RECIST criteria

    Part C1:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    Measurable disease according to RECIST criteria

    -Part C2:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen

    receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)

    negative breast cancer.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    Hematological and biochemical indices within protocol specified ranges at screening.

    Exclusion Criteria:

    Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or

    chemotherapy during the previous 4 weeks (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    Parts A and B:

    Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.

    (a) History of prior dose reductions or dose interruptions while receiving

    cisplatin or carboplatin due to toxicity from the platinum or intolerance to

    either agent.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Principal Investigator: Robert Wesolowski, MD

    Learn More
  • open for enrollment

    Ph III Randomized Mk-3475In Muscle Invasive And Locally Advanced Urothelial Carcinoma Versus Observa

    Protocol: ALLIANCE-A031501

    Principal Investigator: Amir Mortazavi, MD

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