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Results: 264
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Primary Investigator
Buchakjian, Marisa
Secondary Protocol No
HUM00185486
NCT Number
NCT04333537
UM Number
2020.170
Phase
II
III
Status
OPEN TO ACCRUAL
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Primary Investigator
Jasty-Rao, Rama
Secondary Protocol No
HUM00190152
NCT Number
NCT04322318
UM Number
2020.161
Phase
II
Status
OPEN TO ACCRUAL
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Primary Investigator
Vaishampayan, Ulka
Secondary Protocol No
HUM00191651
NCT Number
NCT04510597
UM Number
2020.175
Phase
III
Status
OPEN TO ACCRUAL
This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.
Primary Investigator
Walling, Emily
Secondary Protocol No
HUM00192397
NCT Number
NCT04546399
UM Number
2020.178
Phase
II
Status
OPEN TO ACCRUAL
The purpose of this study is to find new tests that could help determine if the newly infused bone marrow cells are growing well after bone marrow transplantation or if new bone marrow cells are needed. In this study we will use FLT imaging which is an investigational imaging test, and collect blood samples to investigate if the cells are growing well.
Primary Investigator
Yanik, Gregory
Secondary Protocol No
HUM00180979
NCT Number
NCT03541889
UM Number
2021.067
Phase
I
Status
OPEN TO ACCRUAL
This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.
Primary Investigator
Koschmann, Carl
Secondary Protocol No
HUM00193644
NCT Number
NCT04732065
UM Number
2021.047
Phase
I
Status
OPEN TO ACCRUAL
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Primary Investigator
Chugh, Rashmi
Secondary Protocol No
HUM00202966
NCT Number
NCT03715933
UM Number
2021.045
Phase
I
Status
OPEN TO ACCRUAL
The primary objectives of the study are:

In the phase 1 portion of the study: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5458 as monotherapy in patients with relapsed or refractory multiple myeloma (MM).

In the phase 2 portion of the study: To assess the anti-tumor activity of REGN5458 as measured by objective response rate (ORR) and as determined by an Independent Review Committee (IRC).

The secondary objectives of the study are:

In the phase 1 dose escalation portion:

To assess the preliminary anti-tumor activity of REGN5458 as determined by the investigator and measured by ORR, duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS)
To evaluate the pharmacokinetic (PK) properties of REGN5458
To characterize the immunogenicity of REGN5458 In the phase 2
To assess the anti-tumor activity of REGN5458 as measured by: ORR, DOR, PFS, as determined by an IRC and the investigator, rate of MRD negative status and OS
To evaluate the effects of REGN5458 on health-related quality of life (HRQoL) and patient-reported functions and symptoms
To evaluate the safety and tolerability of REGN5458
To evaluate the PK properties of REGN5458
To characterize the immunogenicity of REGN5458
Primary Investigator
Pianko, Matthew
Secondary Protocol No
HUM00196645
NCT Number
NCT03761108
UM Number
2021.031
Phase
I
II
Status
OPEN TO ACCRUAL
This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry.

The patient population will be separated into two cohorts:

Cohort A: Patients with poor response to prior abiraterone defined as:

Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: < 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or;
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone

Cohort B: Patients with response to prior abiraterone, defined as:

Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: >= 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL, or;
Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: >= 6 months duration on abiraterone and confirmed PSA50 response
Primary Investigator
Alumkal, Joshi
Secondary Protocol No
HUM00199477
NCT Number
NCT04986423
UM Number
2021.043
Phase
II
Status
OPEN TO ACCRUAL
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
Primary Investigator
Franson, Andrea
Secondary Protocol No
HUM00196820
NCT Number
NCT04576117
UM Number
2021.059
Phase
III
Status
OPEN TO ACCRUAL