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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

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    Protocol: OSU-15244

    Eligibility:

    Inclusion Criteria:

    Histologically or cytologically-documented, advanced solid tumor of one of the

    following types:

    Anal Carcinoma

    Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or

    extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)

    Neuroendocrine Tumors (well- and moderately-differentiated) of the lung,

    appendix, small intestine, colon, rectum, or pancreas

    Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)

    Cervical Carcinoma

    Vulvar Carcinoma

    Small Cell Lung Carcinoma

    Mesothelioma

    Thyroid Carcinoma

    Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)

    OR

    Any advanced solid tumor, with the exception of colorectal carcinoma (CRC),

    which is Microsatellite Instability (MSI)-High (MSI-H)

    Progression of tumor or intolerance to therapies known to provide clinical benefit.

    There is no limit to the number of prior treatment regimens

    Can supply tumor tissue for study analyses (dependent on tumor type)

    Radiologically-measurable disease

    Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)

    Performance Scale

    Life expectancy of at least 3 months

    Adequate organ function

    Female participants of childbearing potential must be willing to use adequate

    contraception for the course of the study through 120 days after the last dose of

    study medication

    Male participants with partners of must childbearing potential must be willing to use

    adequate contraception for the course of the study through 120 days after the last

    dose of study medication

    Exclusion Criteria:

    Currently participating and receiving study therapy or has participated in a study of

    an investigational agent and received study therapy or used an investigational device

    within 4 weeks of the first dose of study medication

    Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form

    of immunosuppressive therapy within 7 days prior to the first dose of study

    medication

    Active autoimmune disease that has required systemic treatment in the past 2 years

    Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or

    not recovered from an adverse event caused by mAbs administered more than 4 weeks

    earlier

    Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2

    weeks of study Day 1 or not recovered from adverse events caused by a previously

    administered agent

    Known additional malignancy within 2 years prior to enrollment with the exception of

    curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the

    skin and/or curatively resected in situ cancers

    Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

    Has known glioblastoma multiforme of the brainstem

    History of non-infectious pneumonitis that required steroids or current pneumonitis

    Active infection requiring systemic therapy

    Known psychiatric or substance abuse disorders that would interfere with cooperation

    with the requirements of the study

    Pregnant, breastfeeding, or expecting to conceive or father children within the

    projected duration of the study, starting with the screening visit through 120 days

    after the last dose of study medication

    Previously participated in any other pembrolizumab (MK-3475) study, or received prior

    therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1),

    anti-PD-L2, or any other immunomodulating mAb or drug specifically targeting T-cell

    co-stimulation or checkpoint pathways

    Known history of Human Immunodeficiency Virus (HIV)

    Known active Hepatitis B or C

    Received live vaccine within 30 days of planned start of study medication

    Principal Investigator: Manisha H Shah, 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

    Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

    Protocol: OSU-16147

    Eligibility:

    Inclusion Criteria:

    Subject is age 18 years or older;

    Subject must have histologically or cytologically confirmed solid tumor;

    Subject must have locally advanced or metastatic solid tumor;

    Subjects who have progressed or have been intolerant to any standard treatment

    regimen or refused standard treatment, or for which adequate standard therapy does

    not exist.

    Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in

    Solid Tumors (RECIST) version 1.1.

    Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0

    or 1;

    If the subject is a woman of child-bearing potential or man who is sexually active

    with woman of child-bearing potential, the subject agrees to use adequate

    contraception from signing of the ICF, for the duration of study participation; and

    for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of

    IMP for men;

    Subjects who have adequate hematological, renal, hepatic and respiratory functions

    defined.

    The subject is willing to undergo tumor biopsy during the Screening period, or if the

    tumor is inaccessible for biopsy, archived tumor material must be available for

    submission;

    Subjects who voluntarily signed and dated Institutional Review Board approved

    informed consent form in accordance with regulatory and institutional guidelines.

    Exclusion Criteria:

    Female subject who is pregnant or breast-feeding, or any subject expecting to

    conceive or father a child during this study;

    Subjects with uncontrolled and significant inter-current illness.

    Subjects has psychiatric illness/social situations that in the opinion of the

    investigator would limit compliance with study requirements;

    Subjects with known central nervous system (CNS) metastases and/or carcinomatous

    meningitis.

    Subject has received prior therapy for cancer or major surgery within 28 days, or 42

    days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1;

    Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day

    1;

    Subject has been previously treated with an anti-PD-1, anti-PD-L1, anti-PD-L2,

    anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically

    targeting T-cell co-stimulation or checkpoint pathways;

    Subject has been previously treated with mogamulizumab;

    Subject has a history of allergy or hypersensitivity to study drug components;

    Subject has received a live, attenuated vaccine within 28 days prior to Cycle 1 Day

    1;

    Subject has a history of organ transplant or allogeneic bone marrow transplant;

    Subject has any unresolved toxicity Grade > 1 from previous anti-cancer therapy

    Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.

    Subjects who have known active autoimmune disease or a history of autoimmune disease

    which may affect vital organ function or require immune suppressive treatment

    including systemic corticosteroids;

    Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;

    Subjects who have a history of inflammatory bowel disease, Crohn's disease,

    ulcerative colitis, celiac disease, or Wegener's granulomatosis;

    Subject has primary or acquired immunodeficiency or known history of testing positive

    for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;

    Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C

    RNA indicating acute or chronic infection;

    Subject has another active malignancy requiring concurrent intervention;

    Subject who is receiving any other investigational agents;

    Subject has another condition that, in the opinion of the Investigator and/or

    Sponsor, would interfere with evaluation of the IMP or interpretation of subject

    safety or study results;

    Subject has a history of pneumonitis or interstitial lung disease.

    Principal Investigator: Gregory A Otterson, MD

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