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Search Results Within Category "Cancer"

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Suggestions within category "Cancer"

169 Study Matches

MT2016-11 :Autologous Stem Cell Transplant In Patients with Hodgkin Lymphoma (HL) and Non-Hodgkin Lymphomas (NHL)

The treatment (chemotherapy and transplant procedures) is considered standard clinical care that are usually given to the patients with this disease. The research aspect of this study is to collect data on the patients who are being treated on this plan. Patients will be followed throughout the course of their clinical care and for three years after their transplant.

Principal Investigator: Veronika Bachanova, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1611M99805
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• up to 75 years of age
• diagnosis of Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Mature B cell Lymphoma, or Mature T cell Lymphoma
• at least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• chemotherapy resistant disease
• unrelated active infection
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
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A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma

This study compares treatment with niraparib to temozolomide in adult participants who have newly-diagnosed, MGMT unmethylated glioblastoma.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024466
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly-diagnosed intracranial Glioblastoma (GBM)
• unmethylated MGMT promoter
• no prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy
• not pregnant, planning to get pregnant, or breastfeeding
• for participants of child bearing age, highly effective birth control is required
• normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg)
• able to swallow oral medications whole
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• metastatic or predominant leptomeningeal disease
• Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study
• gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels
• cirrhosis or current unstable liver or biliary disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Brain Tumor, GBM, Glioblastoma
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A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)

The purpose of this research is to collect information about the safety and tolerability of the study drug ACE-232, along with how well it works to control metastatic castration-resistant prostate cancer (mCRPC).

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024643
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Metastatic Castration-resistant Prostate Cancer (MCRPC) with - ongoing androgen deprivation therapy (ADT) or had bilateral orchiectomy
• difficult to treat or intolerant to standard treatment
• may be restricted in physically 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:

• spinal cord compression or known brain metastases
• severe cardiovascular disorders
• known gastrointestinal (GI) disorder or GI procedure
• poorly controlled diabetes
• active or uncontrolled autoimmune disease
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), MCRPC, Metastatic Castration-resistant Prostate Cancer, Prostate 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.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015805
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-Cell Non-Hodgkin Lymphoma, B-NHL
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A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies

This study is testing the study drug BDTX-4933 in people with locally advanced (unresectable) or metastatic solid tumors that are characterized by a KRAS, BRAF, or NRAS mutation/alteration(s). The primary objective of the study is to assess how well participants tolerate the drug and if it is effective.

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021016
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• recurrent or advanced (unresectable) or metastatic solid tumors or histiocytic neoplasms with documented RAS or BRAF mutations
• exhausted all available standard-of-care therapies
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• cancer that has a known MEK1/2 mutation
• ongoing anticancer or radiation therapy
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), metastatic cancer, RAS or BRAF mutations, Recurrent cancer
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COG ACNS1833 - A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

The overall goal of this phase 3 non-inferiority study is to assess if selumetinib works as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with low-grade glioma (LGG).

Principal Investigator: Clay Hoerig
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000799
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 21 years old
• all tumors considered low-grade glioma or low-grade astrocytoma
• patients with metastatic disease or multiple independent primary LGG are eligible
• patients must have the ability to swallow whole capsules
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
Conditions: Cancer
Keywords: Brain Cancer, Low Grade Astrocytoma, Low Grade Glioma
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A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023107
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
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DAS181-3-01: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

This research study is for participants who have a weakened immune system (are immunocompromised), have a lower lung infection and are currently using a machine or device to help them breathe. The study will look at whether the study drug, DAS181, works and how safe it is compared with a placebo in adults who have a weakened immune system (immunocompromised) and a parainfluenza virus (PIV) infection of the lower respiratory tract. A placebo looks the same as the study drug but does not contain any active ingredients.

Principal Investigator: Jo-Anne Young, MD
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00005735
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• needs supplemental oxygen ≥2 liters/minute due to low oxygen levels
• immunocompromised, as defined by one or more of the following: received a stem cell transplant, organ transplant, being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past, or has an immunodeficiency due to congenital abnormality
• men and women of childbearing potential must use effective birth control
• see link to clinical trials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• taking any other investigational drug used to treat pulmonary infection
• severe sepsis
• see link to clincialtrials.gov for complete exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Immune Compromised, Influenza, Lower Respiratory Tract Infection, Parainfluenza
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AOST2032; A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin. Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Principal Investigator: Robin Williams
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001870
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 40 years old
• new diagnosis of osteosarcoma of any site
Exclusion Criteria:

• previous treatment for osteosarcoma
• brain metastasis
• history of high blood pressure (140/90) that has required medication
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Osteosarcoma
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001932
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician s Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma (FIRST-308) (FIRST-308)

The main purpose of this study is to learn how well tinengotinib works and how safe tinengotinib is compared with the study doctor’s choice of chemotherapy treatment. The purpose of Part A of the study will be to determine the best dose of tinengotinib to use in Part B of the study. The purpose of Part B is to learn more about how well tinengotinib works and how safe it is compared with the study doctor’s choice of treatment.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021600
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• adenocarcinoma of biliary origin (bile ducts) that can't be surgically removed or is metastatic (spread to other areas of the body)
• cancer has FGFR2 fusion/rearrangement gene status
• received at least one line of prior chemotherapy and one FDA approved FGFR inhibitor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• received two or more FGFR inhibitors, either approved or investigational drugs
• brain or central nervous system (CNS) metastases
• presence of another cancer that requires treatment
• uncontrolled hypertension (blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite treatment with antihypertensive medications)
Conditions: Cancer
Keywords: Cholangiocarcinoma, Clinics and Surgery Center (CSC)
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MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001087
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• no more than 60 years old
• may be unable to work; able to live at home and care for self
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria (differ by diagnosis)
Exclusion Criteria:

• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, ALL, AML, HSCT
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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.

Principal Investigator: Peter Argenta, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014893
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Solid Tumor, Endometrial Cancer, NSCLC, Ovarian Cancer
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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors (BEHOLD-1)

This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025827
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube or endometrial cancer that is metastatic or not able to have surgical treatment
• received or are intolerant to 1 but no more than 3 lines of prior systemic therapy
• 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 criteria
Exclusion Criteria:

• pleural/abdominal effusion/ascites requiring clinical intervention or presence of pericardial effusion
• brain metastasis unless asymptomatic
• heart arrhythmias or ECG abnormalities
• Left ventricular ejection fraction (LVEF) < 50%
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cancer, neoplasm, solid tumors
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.

Principal Investigator: Supriya Gupta
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013494
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• 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.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Conditions: Cancer, Infectious Diseases
Keywords: Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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MT2020-08 A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or azer-cel), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

Principal Investigator: Supriya Gupta
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00009953
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of Non-Hodgkin Lymphoma
• received at least 2, but no more than 7 prior chemotherapy-containing treatment regimens
• previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product
• restricted in strenuous activity but able to walk and able to carry out light work e.g., light house work, office work
• adequate bone marrow, renal, hepatic, pulmonary, and cardiac function (study staff will review)
Exclusion Criteria:

• prior or active CNS disease
• uncontrolled and serious fungal, bacterial, viral, protozoal, or other infection
• active hepatitis B or hepatitis C
• any known uncontrolled cardiovascular disease
• contact study staff for additional exclusion criteria
Conditions: Cancer
Keywords: Non-Hodgkin Lymphoma, Clinics and Surgery Center (CSC)
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A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors (FOG-001-101)

This study is for people who have been diagnosed with cancer that is advanced (means disease has spread from the original site or has come back) or is metastatic (means the disease has spread to other parts of the body). FOG-001 is currently being developed to treat people with cancer. We want see how safe and tolerable FOG-001 is when given alone and together with other anticancer drugs at different dose levels in participants. We also want to see how FOG-001 affects the body and the cancer

Principal Investigator: Ajay Prakash
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025544
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• locally advanced or metastatic solid tumor
• may not be able to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of tumor
Exclusion Criteria:

• history of bone metastasis except patients with mCRPC
• Osteoporosis
• uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
• women who are pregnant, breastfeeding, or planning to be come pregnant
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: cancer, metastatic cancer, Clinics and Surgery Center (CSC), solid tumor
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MT2025-24: A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

This study is for people who have been diagnosed with advanced cancer that has not has not responded to standard treatment. FT836 is a type of cell product made up of “T cells” which are part of the immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells. We want to test the safety of FT836 at different doses, to understand how the body processes and responds to FT836, and to find out what effects FT836 may have on participants and the cancer. The study will also find out what effects FT836, when given alone and with or without chemotherapy treatment (paclitaxel) and/or a monoclonal antibody (cetuximab or trastuzumab.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025723
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed locally advanced or metastatic cancer including breast cancer, ovarian cancer, endometrial carcinoma, gastric/GEJ cancer, head & neck cancer, non small cell lung cancer, or colorectal cancer
• women & men of childbearing age must use highly effective birth control
• may not be able to do physically strenuous activity but walking and able to 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
• other cancer in the past two years
• significant cardiac (cardiac arrhythmias, myocardial infarction, unstable angina or congestive heart failure) or neurological disease (stroke, epilepsy, CNS vasculitis, or neurodegenerative disease)
• active central nervous system (CNS) involvement
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: CAR-T, FT836, metastatic cancer, solid tumor, Clinics and Surgery Center (CSC)
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MT2021-26: Ruxolitinib for Early Lung Dysfunction after HSCT: a Phase II Study (HSCT)

While hematopoietic stem cell transplant (HSCT) is an effective therapy, as many as 25% of patients develop problems with their lungs as a result of this treatment. Bronchiolitis obliterans (BO) is a type of lung injury after HSCT due to graft versus host disease. BO is commonly diagnosed late in patients, when lung injury is hard to treat and can be irreversible, leading to long-term lung disease or even death. The purpose of this research is to learn more about ruxolitinib as an early treatment for lung injury and BO after HSCT. Patients who are diagnosed with early lung dysfunction will be eligible for this research study.

Principal Investigator: Samuel Goldfarb
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014986
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 5 to 60 years old
• undergone allogeneic HCT and experiencing respiratory difficulty
• if able to become pregnant or father a child, must use two highly effective methods of birth control for 90 days after the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active uncontrolled pulmonary infection
• women who are pregnant or breast feeding
• treated with investigational agent for GVHD within the 30 days prior to first dose of study treatment
Conditions: Cancer
Keywords: GVHD, Hematopoietic Stem Cell Transplant, HSCT, Lung, Respiratory
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COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)

This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000331
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 11 years and 45 years old
• confirmed germ cell tumour (non-seminoma or seminoma) OR Exceptionally raised tumour markers (AFP equal or greater than 1000ng/mL and/or HCG equal or greater than 5000 IU/L)
• primary arising in testis, ovary, retro-peritoneum, or mediastinum
• metastatic disease or non-testicular primary
• see link to clinicaltrials.gov for completed Inclusion/Exclusion criteria
Exclusion Criteria:

• other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• peripheral neuropathy equal or greater than grade 2 or clinically significant sensorineural hearing loss or tinnitus
Conditions: Cancer
Keywords: Germ Cell Tumor
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Detecting Ovarian Cancer by Analyzing Volatile Organic Compounds (VOCs) in Human Breath

The purpose of this study is to evaluate the ability of a device (Vocxi Health’s MyBreath Print®) to capture and measure volatile organic compounds (VOCs) in breath samples from women who have a pelvic mass and will be having surgery. The ultimate goal is to develop a screening test for ovarian cancer. We expect that study will take approximately 45 minutes and breath samples will be obtained before and after surgery.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022603
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women who have a pelvic mass and will have surgery
• diagnosis of ovarian, fallopian tube or primary peritoneal cancers or women with a non-malignant ovarian mass (excluding low malignant potential tumors)
• no prior history of cancer
Exclusion Criteria:

• unable to tolerate normal breathing while wearing device mask
Conditions: Cancer
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HM2023-21: A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)

The purpose of this study is to compare the effects of talquetamab in combination with teclistamab (Tal-Tec), the effects of talquetamab in combination with pomalidomide (Tal-P), and the effects of either the combination of elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in treating patients with multiple myeloma, who have not responded to previous treatment.

Principal Investigator: Daniel O'Leary
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022479
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of multiple myeloma
• cancer that has recurred or has not improved with treatment
• previously treated 1 to 4 times (lines of therapy)
• able to walk and complete all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• stroke, transient ischemic attack, or seizure in the past 6 months
• active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Conditions: Cancer
Keywords: Relapsed or Refractory Multiple Myeloma
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A Phase 1B/2 pan-tumor, open-label study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXD) in subjects with recurrent or metastatic solid tumors (IDeate-Pantumor02)

The purpose of this study is to learn more about an investigational drug called ifinatamab deruxtecan (I-DXd; DS-7300. It is being studied to see if it is safe, and if cancer improves while taking it. I-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumor cells to deliver chemotherapy directly to tumor cells while sparing healthy cells.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022970
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• disease progression on or after the previous standard-of-care regimen for advanced/metastatic cancer
• unable to do strenuous activity but able to walk and do work of a sedentary nature, e.g., light house work, office work
• additional criteria required based on the type of cancer (pancreatic, breast, bladder, etc.)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd
• clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Conditions: Cancer
Keywords: Cancer, Recurrent or Metastatic Solid Tumors, Clinics and Surgery Center (CSC)
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MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022432
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: LBLC, Mantle Cell Lymphoma (MCL), Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
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AALL2321; A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.

Principal Investigator: Peter Gordon
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025534
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Eligibility Screening: All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL2321.
• Age: Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment.
• Diagnosis: Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 WHO classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage.
Exclusion Criteria:

• Patients with Down Syndrome.
• Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
• Prior therapy: Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy.
Conditions: Blood Disorders, Cancer, Children's Health
Keywords: ALL, KMT2A-G, KMT2A-R, KMT2A-Rearranged, Newly Diagnosed Acute Lymphoblastic Leukemia
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A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FR&#945;-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this study is to look at the safety and efficacy of neoadjuvant ( before surgery) carboplatin and mirvetuximab soravtansine for women who have folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. All participants will receive an intravenous infusion of MIRV in combination with carboplatin for up to 6 - 9 Cycles

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC092
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• have been treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
• previous clinical diagnosis of noninfectious interstitial lung disease
• eye conditions requiring ongoing treatment/monitoring
• history of another malignancy within past 3 years
Conditions: Cancer
Keywords: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US). Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. Participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020047
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 45 years old
• uncomplicated pregnancy at gestational week 30 or beyond, or birth of a child within the past 6 months
• history of ≥ 4 cigarettes per month during the six months prior to pregnancy
• motivation to become and/or stop smoking after delivery
• willing to use birth control for the 12 weeks of the study
• live in the continental US and have a device to connect to the internet for participation
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• major depressive disorder
• current or within the past 3 months treatment for drug or alcohol use
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: post partum, smoking
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AHOD2131, A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001972
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 5 to 60 years old
• newly diagnosed untreated confirmed Hodgkin lymphoma
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• patients with nodular lymphocyte predominant Hodgkin lymphoma
• patients with a history of active interstitial pneumonitis or interstitial lung disease
• administration of prior chemotherapy, radiation, or antibody-based treatment for classic Hodgkin Lymphoma (cHL)
• prior solid organ transplant
• prior allogeneic stem cell transplantation
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: cHL, Hodgkin Lymphoma, Hodgkin's, Lymphoma
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A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)

The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.

Principal Investigator: Faysal Haroun
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025046
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Non-Small Cell Lung Cancer, NSCLC
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A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration- Resistant Prostate Cancer Previously Treated With Chemotherapy

This is a research study designed to test how well a new medication (xaluritamig) works compared to other treatments for people with metastatic castration-resistant prostate cancer. These patients have already been treated with a certain chemotherapy. Participants will be randomly assigned to one of two groups: xaluritamig or either cabazitaxel (existing cancer treatment) or another treatment chosen by the doctor. The goal of the study is to find out which treatment is more effective and safer for patients.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023844
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• evidence of progressive disease
• completed requirements for previous treatment
• may not be able to do strenuous activity but able to walk and able to 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:

• history of central nervous system (CNS) metastasis
• significant side effects from previous treatment that haven't resolved
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Castration-resistant Prostate Cancer, Prostate
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