
Search Results
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.
• 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
• 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
ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
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.
• 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
• 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)
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)
Disruption of estrogen signaling by drugs called selective estrogen receptor degraders (SERDs) is one of the treatment options for patients with estrogen receptor positive (ER+) cancers. Imlunestrant is a SERD that disrupts estrogen signaling, and therefore should stop or slow down tumor growth in ER+ cancers. This study will help answer research questions about the safety of imlunestrant and any side effects, and how imlunestrant compares to standard-of-care endocrine therapy.
• diagnosis of ER+, HER2- early-stage invasive breast cancer without evidence of distant metastasis
• completed surgery
• received at least 24 months but not more than 60 months of any endocrine therapy after treatment
• may be limited with strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• any evidence of metastatic disease
• more than a 6 month consecutive gap in therapy during the course of prior adjuvant endocrine therapy
• history of any other cancer
• women who are pregnant, breastfeeding, or expecting to conceive or men expecting to father children
MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies
The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.
• hematological cancer needing stem cell transplant
• 60 years old or younger
• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
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.
• 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
• 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
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.
• 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
• 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
COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.
• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
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.
• 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
• 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
Effect of Kava on Anxiety and Stress in Cancer Survivors
This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over design to test the safety and efficacy of a 14-day course of kava in reducing anxiety and stress in adult cancer survivors. The primary objectives of this study are: 1) determine the effect of kava on anxiety in cancer survivors using the PROMIS anxiety score; and 2) determine the safety of kava in cancer survivors using CTCAE v5.0.
• Adult ≥ 18 years old
• Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
• Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
• Known allergy to kava
• Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
• Use of herbal supplements within 14 days of study registration,
• Anti-cancer therapy within 28 days prior to registration and/or during study participation, except for aromatase inhibitors
• Known liver disease such as cirrhosis
• Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
• Chronic use of high-intensity statin therapy
• Women who are pregnant, intend to become pregnant, or are nursing
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC
This study will evaluate the safety and tolerability of EG 70, a gene therapy, which is given inside the bladder. This study will measure its effectiveness on eliminating bladder tumors in participants with NMIBC who have failed or did not receive adequate Bacillus Calmette- Guérin (BCG) therapy. The study drug will be given into the lining of the bladder. This may cause an immune response inside the bladder and kill the cancer cells.
• BCG-unresponsive NMIBC with carcinoma in situ (CIS
• ineligible for or have elected not to undergo cystectomy
• women of childbearing potential must be willing to use highly effective birth control methods; Males are required to use a condom for the duration of the study treatment through 3 months post-dose
• at least walking 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 criteria
• other active cancer that required treatment in the past two years
• history of partial cystectomy
• history of severe asthma or other respiratory diseases
• human immunodeficiency virus, Hepatitis B, or Hepatitis C infection
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-33 A Phase 1/2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
This study is designed to determine whether BSB-1001 - a product made of genetically modified cells - is safe and possibly effective when given to patients with Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) who are also receiving a stem cell transplant with a matched donor.
• ages 18 - 70 years inclusive, having a alloHCT.
• any of the following high-risk hematologic malignancies: • AML which has been treated with at least two lines of therapy, and refractory or relapsed • ALL • MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk • AML patients who have been treated with at least two lines of therapy, and refractory or relapsed
• suitable for one of the approved conditioning regimens as defined in the protocol
• must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• weight \> 100 kg. (220 lbs)
• prior history of allogeneic or autologous stem cell transplantation
• previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the exception of patients with ALL previously treated with an autologous CAR-T product.
• recent treatment with other investigational agents
• history of treatment with checkpoint inhibitor therapy within 3 months of transplantation
• women who are pregnant or breast feeding
• uncontrolled bacterial, viral, or fungal infections
• CNS involvement that hasn't responded to intrathecal chemotherapy and/or standard cranial- spinal radiation.
• unable to work; able to live at home and care for most personal needs; requires occasional assistance, but is able to care for most personal needs or better performance
A Phase 1B/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7- H3 Antibody-Drug Conjugate (ADC), In combination with Atezolizumab with or Without Carboplatin as First Line Induction or Maintenance, In Subjects with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)
This study is being done to learn more about the safety and effectiveness of ifinatamab deruxtecan (I-DXd) against extensive stage small cell lung cancer.
• diagnosis of extensive small cell lung cancer
• have not received any prior treatment (first line therapy)
• may be unable to do physically strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• agree to use a contraceptive method that is highly effective
• see link to clincialtrials.gov for complete inclusion criteria
• any of the following within the past 6 months: cerebrovascular accident, (CVA) transient ischemic attack, (TIA) or another arterial thromboembolic event
• uncontrolled or significant cardiovascular disease
• history of another cancer in the past 5 years
• history of bone marrow, stem cell, or solid organ transplant
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.
• diagnosis of primary or secondary myelofibrosis
• may be 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 which are specified by diagnosis
• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS)
This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.
• new diagnosis of non-small cell lung cancer (NSCLC) OR metastatic (in other areas of the body) or is too advanced for treatment that will cure the cancer
• tumor has an epidermal growth factor receptor gene (EGFR) mutation
• able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work, but can't do strenuous physical activity
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• not have fully recovered from surgery, or has surgery planned during the time the participant is expected to be in the study
• uncontrolled tumor-related pain
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).
• 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
• 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
A Phase 2 Randomized Trial of Neoadjuvant Enoblituzumab versus Standard of Care in Men with High-Risk Localized Prostate Cancer: The Help Elucidate & Attack Longitudinally (HEAT) Prostate Cancer Randomized Study (HEAT)
This study aims to improve prostate cancer treatment by testing a drug, enoblituzumab, which targets a protein called B7-H3. Previous research suggests it might boost the immune system to fight cancer. The objective is to see if it delays cancer return compared to standard treatment and identify who responds best.
• confirmed adenocarcinoma of the prostate
• an initial prostate biopsy within 3 months of enrollment is available for review, showing at least 3 positive cores, including one with ≥50% involvement and Gleason ≥8
• radical prostatectomy has been scheduled
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• known lymph node involvement on CT or distant metastases on CT or bone scan; non-adenocarcinoma prostate cancers
• previous or concurrent use of radiation, hormonal, biologic, chemotherapy, immunotherapy, experimental agents, 5α-reductase inhibitors, or systemic corticosteroids
• autoimmune diseases requiring systemic immunosuppression; malignancy within the last 3 years; uncontrolled major infections or illnesses
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune DIseases
This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.
• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women with Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6
This study is being conducted to determine the safest and most effective dose of TORL-1-23 in treating advanced platinum-resistant ovarian cancer.
• diagnosis of advanced (unresectable) or metastatic (has spread) high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer
• positive for CLDN6 expression
• have platinum-resistant disease
• may not be able to do strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment
• must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion criteria
• have not recovered from serious side effects of previous treatment
• progressive or symptomatic brain metastases
• history of significant heart disease
• history of another cancer within 3 years (exception of basal or squamous cell carcinoma of the skin)
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1 Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease
The purpose of this study is to determine the dose of a new medication being studied for babies who are exposed to cytomegalovirus during birth. This is called congenital cytomegalovirus (cCMV). Cytomegalovirus is the leading cause of hearing loss and the leading viral cause of developmental delays in children. If a baby participates in this study, in addition to the study medication, he/she will still receive the current best treatment for cCMV, which is oral Valganciclovir.
• age at enrollment is 90 days or younger
• gestational age at birth is 32 weeks or greater
• diagnosis or symptomatic congenital CMV (cytomegalovirus)
• minimum weight of 2.6kg (5 lb, 12 oz.)
• receiving other investigation drug
• high bilirubin or ALT
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.
• 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
• 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
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.
• 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
• 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
A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Solar-Stage)
The purpose of this study is to test the safety and effectiveness of Copper Cu 64 PSMA I&T in detecting lesions during a PET scan. This study is open to men with newly diagnosed prostate cancer who plan to have a prostatectomy and lymph node removal. Copper Cu 64 PSMA I&T is an investigational PET imaging agent, given to you via IV injection, similar to the way other imaging agents are used in many other types of scans. Cu 64 specifically targets the prostate specific membrane antigen (PSMA) that is found on the surface of metastatic prostate cancer cells. Increased image contrast may make it easier for the doctor to see smaller lesions compared to other imaging agents.
• newly diagnosed with prostate adenocarcinoma with intermediate / high risk features
• planned prostatectomy with pelvic lymph node dissection
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• received any therapy for prostate cancer before surgery
• not able to have a PET scan
• had a prostate-specific membrane antigen (PSMA) PET scan in the past 90 days
ANBL2131/MT2024-35- A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, 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. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.
• Must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
• Newly diagnosed, HRNBL defined as one of the following: a. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification b. Age:: greater than or equal to 547 days and INRG Stage M regardless of biologic features c. Any; age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy d. Age: greater than or equal to 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy BSA: Patients must have a BSA greater than or equal to 0.25 m2
• Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
• Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
• Patients with known bone marrow failure syndromes.
• Patients on chronic immunosuppressive medications
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.
• Female patients who are pregnant or breastfeeding their infant.
MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.
• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people 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 transplant
• study staff will review additional requirements
• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)
The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.
• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
• other medical or mental health diagnosis that would limit compliance with study requirements
MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma
This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.
• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain (P4P)
Back pain is one of the most common and disabling chronic pain conditions in the United States. Most cases remain poorly managed and many sufferers face barriers to equitable care which has led to unacceptable disparities in back pain management, with Black and Hispanic Americans, as well as individuals with less education and income, experiencing poorer outcomes. This project aims to address barriers that currently exist within the healthcare system by co-developing with community stakeholders, accessible evidence-based complementary and integrative health approaches that can be offered in community settings.
• pain that has lasted at least 3 months
• pain that limits ability to do everyday activities
• identify as a member of a racial or ethnic minoritized group (American Indian/Alaska Native, Asian, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islanders) OR
• have a household income of less than $50,000/year
• women who are pregnant
• receiving radiation or chemotherapy for cancer
• experience severe mental health symptoms not managed by a healthcare provider