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Search Results Within Category "Cancer"

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Suggestions within category "Cancer"

118 Study Matches

MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study

The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).

Punita Grover
Not specified
This study is NOT accepting healthy volunteers
STUDY00014365
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Inclusion Criteria:

• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Cancer
Clinics and Surgery Center (CSC), Acute-graft-versus-host Disease, aGVHD, HCT, Hematopoietic Cell Transplant
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A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy

This study is trying a new treatment (Xaluritamig) for men whose prostate cancer returned after the first treatment, but has not spread. The objective is to determine if Xaluritamig is safe and works well without causing negative side effects seen in other treatments. Participants will get Xaluritamig through a vein in their arm over six times with doctors observing for side effects and to see how the cancer reacts.

Nicholas Zorko
18 years and over
This study is NOT accepting healthy volunteers
STUDY00022748
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate
• treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both with intention of cure
• PSA has doubled in 12 months or less
• normal testosterone level (greater than 150ng/dL)
• must be able to walk, carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:
evidence of metastatic disease in conventional CT scan and/or bone scan (positive on PSMA PET scan only is permitted)
• prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer
• prior systemic biologic therapy, including immunotherapy, for prostate cancer
• men with a female partner of childbearing potential or who are pregnant, who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of xaluritamig
Cancer
Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer, Prostate Cancer
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A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019273
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Inclusion Criteria:

• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
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MT2023-05: GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)

The primary purpose of this study is to identify a safe dose of GTB-3650. The study also provides preliminary disease response information for larger future studies. GTB-3650 is designed to target CD33 on leukemia/MDS cells. Cancer cells must overexpress CD33 (also referred to as CD33+), a marker found in some blood/bone marrow cancers. Based on similar studies and lab studies, it is felt there is a chance of benefit from the study treatment but the duration of benefit is unknown.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00022729
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Inclusion Criteria:

• at least 18 years old
• diagnosis of refractory or relapsed myeloid cancer
• not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are usually given for treatment
• sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the last dose of study drug
• for the Dose Finding Component Only: must agree to stay within a 60 minute drive of the Study Center through the last study visit after the first dose (29 days)
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• candidate for hematopoietic stem cell transplant (HSCT)
• known history of HIV
• active Hepatitis B or Hepatitis C
• known autoimmune disease requiring active treatment
Cancer
Acute Myeloid Leukemia, AML, Myelodysplastic Syndromes, Myeloid Malignancy
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HM2024-11: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLATUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA

The purpose of this study is to compare the efficacy and safety of glofitamab, a novel cluster of differentiation (CD) 20/CD3 bispecific antibody, in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola‑R‑CHP) versus Pola‑R‑CHP in patients with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Sanjal Desai
18 years and over
This study is NOT accepting healthy volunteers
STUDY00022042
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Inclusion Criteria:

• 18 to 80 years old
• have not received any treatment for Large B-Cell Lymphoma
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior solid organ transplantation
• history of significant cardiovascular disease
• current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• clinically significant liver disease
• chronic hepatitis B infection, hepatitis C, or HIV
Cancer
Clinics and Surgery Center (CSC), Large B-Cell Lymphoma, LBCL, lymphoma
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MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T(TM)

This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.

Benjamin Manning
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019932
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Inclusion Criteria:

• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
Cancer
Clinics and Surgery Center (CSC), advanced cancer, cancer, metastatic cancer, solid tumors
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HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts

There are certain genetic changes in the leukemia cell thought to drive the disease in patients with acute myeloid leukemia. Ziftomenib is an investigational drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. The purpose of this study is to determine the safe dose of an investigational new drug (ziftomenib) used in combination with other study drugs i.e., venetoclax and azacitidine, to treat cancer. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and how ziftomenib works in combination with the other study drugs (venetoclax and azacitidine).

Mark Juckett
18 years and over
This study is also accepting healthy volunteers
SITE00001987
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Inclusion Criteria:

• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• other types of leukemia
• active involvement of central nervous system
• clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• women who are pregnant or breast feeding
• additional criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, AML, Leukemia
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A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour (TANGENT)

We are conducting research on a new drug called emactuzumab. Emactuzumab is a new type of monoclonal antibody. An antibody is a protein produced by the body’s immune system to detect harmful substances. A monoclonal antibody is an artificially created protein that acts like a human antibody. Each antibody is specific for a single substance. Emactuzumab antibodies are aimed at blocking a type of protein called “CSF-1 receptors” from being able to work and to stop a tumor from growing. We will also examine how long this response will last, the impact on movement and quality of life. We will also examine whether participants need surgery during treatment with emactuzumab. In this study, we will also examine the safety of emactuzumab.

Keith Skubitz, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00022604
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Inclusion Criteria:

• at least 12 years old
• diagnosis of local or diffuse TGCT where surgery is not a good option
• women who are of child bearing age must agree to use a highly effective method of contraception
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• women who are pregnant or breast feeding
• medical conditions, including auto-immune, that require systemic immunosuppression
• current or chronic history of liver disease
• significant heart disease
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), bone cancer, joint cancer, Tenosynovial Giant Cell Tumor, TGCT
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MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)

CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.

Christen Ebens
Not specified
This study is NOT accepting healthy volunteers
SITE00001764
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Inclusion Criteria:

• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
Cancer, Rare Diseases
Clinics and Surgery Center (CSC), CGD, Chronic Granulomatous Disease, Gene Therapy, GT, HCT, Hematopoietic Cell Transplant
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PEPN2312; A Phase 1 study of GRN163L (Imetelstat, IND# 170891, NSC# 754228) in combination with fludarabine and cytarabine for patients with acute myeloid leukemia that is in second or greater relapse or that is refractory to relapse therapy; myelodysplastic syndrome or juvenile myelomonocytic leukemia in first or greater relapse or is refractory to relapse therapy

This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.

Robin Williams
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00022789
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Inclusion Criteria:

• Between 1 year and less than 18 years of age at enrollment
• Patients, with or without Down syndrome (DS), and with de novo acute myeloid leukemia, therapy-related AML, MDS or JMML.
• In second or greater relapse or refractory AML or First or greater relapse of MDS, or First or greater relapse of JMML
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Pregnant or breast-feeding
• Currently receiving investigational drugs or other anti-cancer agents
Cancer
acute myeloid leukemia, AML, JMML, juvenile myelomonocytic leukemia, MDS, myelodysplastic syndrome
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A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.

Boris Winterhoff
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014893
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Inclusion Criteria:

• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
Exclusion Criteria:

• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019229
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Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
Cancer
Solid Tumors, Clinics and Surgery Center (CSC)
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MT2024-06: Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation

To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) after allogeneic hematopoietic cell transplantation (alloHCT)

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00021822
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Inclusion Criteria:

• at least 18 years old
• relapsed following hematopoietic cell transplant (HCT)
• unable to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, such as light house work, office work
• Original alloHCT donor is available and willing to undergo apheresis
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• patients who have undergone more than one alloHCT
• ongoing active acute or chronic Graft vs Host Disease (GVHD) and are taking systemic immunosuppressive agents
• active CNS disease
• active or uncontrolled viral, bacterial, or fungal infection
• history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Acute Leukemia, AML, Leukemia, Myeloid
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Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

FT536 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells. FT536 is produced by growing cells that come from a healthy human donor. The primary purpose of this study is to identify a safe dose of FT536 cells when given alone (monotherapy).

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021809
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Inclusion Criteria:

• epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has recurred after treatment (no limit to the maximum number of prior treatments)
• must have received prior bevacizumab
• if there is a BRCA mutation, must have received a prior PARP inhibitor
• agree to the have an intraperitoneal catheter placed before the 1st dose of study drug
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months
• active autoimmune disease requiring systemic immunosuppressive therapy
• history of severe asthma and currently on chronic medications (more than inhalers)
• received enoblituzumab
• CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or needing medications for these conditions in the past 2 years
Cancer, Women's Health
Clinics and Surgery Center (CSC), Fallopian Tube Cancer, Gynecologic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.

Marie Hu
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015805
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Inclusion Criteria:

• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), B-Cell Non-Hodgkin Lymphoma, B-NHL
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MT2023-27: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer

This is an early study of TAK-280 for people diagnosed with a type of cancer that cannot be treated or removed by surgery and the tumor is growing or has spread during or after other standard cancer treatment.

Nicholas Zorko
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019687
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Inclusion Criteria:

• at least 18 years of age
• confirmed, locally advanced or metastatic cancers that can not be treated surgically
• unable to do strenuous activity but can walk and is able to do light work such as house work, office work
Exclusion Criteria:

• history of an autoimmune disease
• major surgery or traumatic injury within 8 weeks before the first dose of the study medication
• unhealed wounds from surgery or injury
• ongoing or active infection
• contact study staff for additional requirements
Cancer
Clinics and Surgery Center (CSC), Unresectable Locally Advanced or Metastatic Cancer
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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

David Potter
18 years and over
This study is NOT accepting healthy volunteers
SITE00001846
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Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Cancer, Women's Health
Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.

Manish Patel
18 years and over
This study is NOT accepting healthy volunteers
SITE00002088
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Inclusion Criteria:

• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Metastatic Cancer, Solid Tumor Cancer
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MT2023-38 Monitoring of Immune Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies

The purpose of this research is to collect and store specimens and information about the recovery of the immune system following a stem cell transplant (HCT) or immunotherapy to treat a cancer or blood disease. Samples from many people are being collected and stored so they can be used for research now and in the future.

Jeffrey Miller, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00021493
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Inclusion Criteria:

• planning to have a Hematopoietic Cell Transplant (HCT), gene therapy or other cell therapy or immunotherapy
• allogeneic related donors
Cancer
Clinics and Surgery Center (CSC), cell therapy, gene therapy, HCT, Hematopoietic Cell Transplant, immunotherapy
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize your cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Half of women in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00002052
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Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer: Ovarian cancer includes ovarian, fallopian tube and primary peritoneal cancers
• must have undergone an attempt at maximal cytoreductive surgery and a bilateral salpingo-oophorectomy
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• surgery no more than eight weeks before starting the study
• able to take medications by mouth
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease
• received previous hormone therapy for the treatment of this disease
• history of severe cardiac disease
• central nervous system metastases
• active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection
• neuropathy causing more than moderate pain and affecting daily activity
Cancer, Women's Health
Fallopian Tube Serous Cancer, Ovarian Low Grade Serous Cancer, Peritoneal Serous Cancer, Clinics and Surgery Center (CSC)
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A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer

The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001947
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Inclusion Criteria:

• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:

• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)
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Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC) therapy in subjects with inoperable, advanced, somatostatin receptor expressing (SSTR+), well-differentiated gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1) (ACTION-1)

The main purpose of this the study is to find out if a new investigational drug RYZ101 more effectively treats your cancer than the standard therapy, and to see if it is safe, tolerable, and to learn the pharmacokinetics (PK).

Edward Greeno, M.D.
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021459
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Inclusion Criteria:

• diagnosis of inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine cancer
• able to walk and complete all self care but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• significant cardiovascular disease such as heart failure
• hypertension that isn't controlled by medication
• uncontrolled diabetes
• history of liver cirrhosis
Cancer
Clinics and Surgery Center (CSC), Gastric Cancer, Neuroendocrine tumors, Pancreas, Pancreatic Cancer, Stomach Cancer
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MT2022-49: Early identification of cognitive side-effects of immunotherapy

This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019811
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Inclusion Criteria:

• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
Exclusion Criteria:

• presence of speech or hearing problem
• diagnosis of cognitive impairment
Cancer
Clinics and Surgery Center (CSC), CAR-T, Chimeric Antigen Receptor T-Cell Therapy
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Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR (VAPOR 2)

The purpose of this study is to determine the safety and efficacy of the Vanquish System treatment in men who have intermediate risk prostate cancer. In this study, the Vanquish System will be used to destroy cancerous tissue in the prostate. After treatment, participants will undergo tests that will assess presence of prostate cancer.

Christopher Warlick, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019145
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Inclusion Criteria:

• 50 years or older
• PSA no more than 15 ng/ml
• cancer stage less than or equal to T2c
• had a multiparametric MRI within the last 12 months and MRI software guided fusion biopsy of the prostate within the last 6 months
Exclusion Criteria:

• prior surgery, intervention, or minimally invasive therapy, for the prostate cancer or bladder neck
• taking medications that have hormonal effects on the prostate or PSA or or testosterone supplement
• significant medical or mental health diagnosis (study staff will review)
Cancer, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Prostate Cancer, Prostate Cancer
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A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer (ARASTEP)

ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.

Emmanuel Antonarakis
18 years and over
This study is NOT accepting healthy volunteers
SITE00001890
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Inclusion Criteria:

• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Cancer
Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
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Phase 1, Multi-Center, Open-Label Study of VT3989 in Patients with Refractory Locally Advanced or Metastatic Solid Tumors Enriched for Tumors Harboring Mutations of the Neurofibromatosis Type 2 Gene (mutant NF2 or mNF2)

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Robert Kratzke
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019430
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Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.

Gautam Jha
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018433
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Inclusion Criteria:

• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
Cancer
Urothelial Carcinoma
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MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021552
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Inclusion Criteria:

• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
Cancer
blood cancer, hematopoietic stem cell transplantation (HSCT)
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MT2023-10: A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma

We are studying FT522 - a new product that is made by modifying cells in a laboratory - both with and without additional drugs, to see if it can help treat people with B-cell lymphoma. This study is for people who have had at least one treatment for their lymphoma, but the cancer either returned or did not respond to the treatment. We are testing this product to see what side effects it might have, as well as to see whether it is effective at treating B-cell lymphoma.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001976
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Inclusion Criteria:

• diagnosis of B-cell lymphoma (BCL)
• at least 1 prior systemic regimen of treatment
• men and women participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
Exclusion Criteria:

• women who are pregnant or breastfeeding
• capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• body weight less than 50 kg (110 lb.)
• additional medical diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lymphoma, Relapsed/Refractory B-Cell Lymphoma
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OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

We are doing this study because we want to find out if observation is as good as the usual care for breast cancer. The usual approach for patients with early-stage triple-negative breast cancer (TNBC) who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery. Participants will either get pembrolizumab for up to 27 weeks, or will not receive any treatment and will be observed for up to 27 weeks. We will continue to follow participants every 6 months for 5 years and watch for side effects or cancer coming back. After that, participants will be checked every year for a total of 10 years after the study.

Anne Blaes, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00021547
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Inclusion Criteria:

• at least 18 years old
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• no cancer remaining in the breast or lymph nodes after the completion of neoadjuvant therapy (complete response)
• Estrogen (ER) and progesterone (PR) no more than 10% and HER2-negative
• if cancer was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors/breasts
• must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles
• not pregnant and not nursing
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stage IV (metastatic) breast cancer
• known active liver disease -medical conditions that require chronic systemic steroids (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years
Cancer
Breast Cancer, TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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