Search Results Within Category "Cancer"
Suggestions within category "Cancer"
National Liver Cancer Screening Trial (TRACER)
Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.
• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
Registry Study of Childhood Cancer in Minnesota
The aim of this study is to obtain newborn blood spots (NBS) and tumor specimens for children and adolescents diagnosed with malignant neoplasms.
• 0 to 21 years of age
• child diagnosed with any type of tumor or cancer
• born in a state that banks newborn blood spots
• able to understand English or Spanish
• parents or siblings may also contribute specimens
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
DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)
The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).
• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• 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
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)
The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
AALL2131; An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia
This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.
• Age: Patients must be >365 days and < 22 at the time of enrollment
• Diagnosis: Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
• Known history of chronic myeloid leukemia (CML)
• ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
• Down syndrome (trisomy 21)
• Pregnancy and breast feeding
MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.
• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
This study is testing a stem cell (bone marrow) transplant for people with certain blood disorders. The goal is to find a treatment approach that is effective while causing fewer side effects. Participants will receive treatment to prepare their body, followed by a transplant using stem cells from a donor. After the transplant, they will receive medications to help prevent complications.
• up to 75 years of age
• have a matched related donor
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• recent stem cell transplant within the past 3 months
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
This study is testing an investigational drug called XmAb541 for people with advanced solid tumors that test positive for a protein called CLDN6. XmAb541 is a type of immunotherapy designed to help the body's immune system recognize and attack cancer cells. The first part of the study will test different doses of XmAb541 to determine a safe and appropriate dose for future research. Once a recommended dose is identified, additional participants will receive that dose in the second part of the study. Researchers will evaluate the safety of XmAb541, how the body responds to the treatment, and whether it shows signs of helping to control or shrink cancer.
• ovarian, fallopian tube, peritoneal, endometrial, uterine, or another CLDN6-positive cancer that has returned, spread, or not responded to previous treatment
• able to carry out most daily activities with limited assistance
• see link to ClinicalTrials.gov for complete Inclusion Criteria
• active autoimmune disease
• significant heart, lung, or gastrointestinal disease
• active hepatitis B or hepatitis C infection
• see link to ClinicalTrials.gov for complete Exclusion Criteria
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.
• 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
• 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
MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.
• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
HM2025-23: Phase 3 Randomized, Double-Blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 mutated or KMT2A Rearranged Acute Myeloid Leukemia
AML is a type of blood cancer where infection fighting cells called white blood cells (WBCs) don’t grow up or “mature” like they are supposed to. Instead, they stay stuck as infant or immature “blast” cells. This study will investigate the potential risks and benefits of adding a targeted therapy called ziftomenib to intensive therapy (7+3) OR non-intensive (Venetoclax + Azacitidine) for patients whose cancers are found to have KMT2A rearrangements or mutations in the NPM1 gene. We will also see if the use of ziftomenib as maintenance therapy following consolidation is beneficial.
• diagnosis of Acute Myeloid Leukemia (AML)
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• must agree to use a highly effective method of birth control
• see link to clincialtrials.gov for complete Inclusion criteria
• received prior therapy for AML
• involvement of central nervous system
• history of another type of cancer
• women who are pregnant or breastfeeding
• other significant medical illness,
• see link to clinicaltrials.gov for complete Exclusion criteria
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.
• 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)
• 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
A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, EIK1003 (IMP1734), as monotherapy and in combination in participants with advanced solid tumors
This study tests IMP1734, a PARP1-selective inhibitor, in patients with breast, ovarian, or metastatic castration-resistant prostate cancer (mCRPC) with specific HRR gene mutations. The study includes dose escalation to identify the maximum tolerated or achievable dose (MTD/MAD), dose optimization to evaluate the safety, tolerability, and effectiveness of select doses, and dose expansion to test the recommended dose for monotherapy. IMP1734 is taken as daily oral tablets, and the trial lasts up to three years from the first treatment of the last participant.
• breast cancer: must have had at least one prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting and hormonal therapy if HR+
• HGSOC, high-grade endometrioid EOC, fallopian tube, or primary peritoneal cancer: must have had at least one prior platinum-based chemotherapy for advanced disease
• mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy
• must agree to use an effective method of contraception from study entry up to 6 months after the last dose of IMP1734
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• recent anti-cancer therapy (within 28 days) or prior use of PARP1-selective inhibitors
• active CNS metastases, carcinomatous meningitis, or significant cardiac issues (QTcF >470 ms or <340 ms)
• active infections, including hepatitis B or C, or bleeding disorders
• inability to swallow oral medications or conditions affecting drug absorption
A Randomized Open-label Phase 2 Study of TALazoparib with or without ENzaluTamide in Patients with Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate or Darolutamide (TALENT) (TALENT)
The purpose of this study is to find out whether a study drug called talazoparib, given alone or in combination with enzalutamide, can help slow down or delay the growth of prostate cancer in people whose cancer has spread and no longer responds to hormone therapy. This study includes people whose cancer has specific genetic changes and who have previously been treated with another prostate cancer medicine called abiraterone acetate.
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC) with mutations in DNA repair genes involved in homologous recombination repair (HRR)
• cancer has progressed despite prior hormone-based treatment and shows ongoing disease activity
• ability to perform most daily activities
• see link to clinicaltrials.gov for complete inclusion criteria
• prior treatment with certain prostate cancer therapies (such as PARP inhibitors or specific chemotherapy/targeted drugs)
• serious or uncontrolled medical conditions that could affect safety (such as uncontrolled heart disease, seizures, or brain/spinal metastases)
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-13: First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
The upfront treatment for astrocytoma is surgery, radiation therapy, and chemotherapy. There is currently no standard therapy for when the astrocytoma has returned (recurs) or re-grows (progresses). This study uses the investigational drug FT536, a cell therapy that stimulates the immune system into action to treat astrocytoma that has returned or regrown. FT536 is a type of cell therapy made up of “natural killer” or NK cells, a type of immune blood cell that are known to attack cancer cells. The primary purpose of this study is to identify a safe dose of FT536 cells when given as an intratumoral injection and to identify the side effects of treatment with FT536. Another purpose of this study is to understand how FT536 alters the immune system in the brain and body.
• 18 to 75 years old
• confirmed Grade 4 astrocytoma that has reoccurred or progressed
• completed usual antitumor treatment including surgery, radiation therapy, and temozolomide with or without Optune/ Tumor Treatment Fields (TTF)
• able to have MRI scans with contrast agent
• completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function when starting the study
• must use a highly effective form of birth control from the first study visit until at least 3 months after the dose of FT536
• see link to clinicaltrials.gov for complete Inclusion criteria
• prior treatment with bevacizumab or any other cellular therapy
• prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy
• women who are pregnant or breastfeeding
• history of another cancer in the past 5 years
• other significant medical or social conditions that would limit the ability to complete the study requirements
• see link to clinicaltrials.gov for complete Exclusion criteria
HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination with CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML).
This study is meant for participants who have been diagnosed with acute myeloid leukemia (AML) and have a specific mutation in a gene called TP53. The study will give these participants an investigational drug called bortezomib in combination with an approved drug for AML, CPX-351 (brand name: Vyxeos). The researchers are studying this combination to find out if it is safe to give to people, as well as to find out how well it works for people who have AML with the TP53 mutation.
• have not received any systemic chemotherapy for the treatment of AML
• able to care for self but may be unable to carry on normal activity or to do active work
• sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
• active central nervous system malignancy or symptoms of CNS involvement
• cardiac disease including congestive heart failure with symptoms, heart attack (myocardial infarction) in the past 6 months, serious arrhythmia, unstable angina
• women who are pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2022-49: Early identification of cognitive side-effects of immunotherapy
This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.
• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
• presence of speech or hearing problem
• diagnosis of cognitive impairment
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
EXPANDED ACCESS PROGRAM TO TREAT PATIENTS WITH PREVIOUSLY TREATED METASTATIC PANCREATIC ADENOCARCINOMA WITH DARAXONRASIB
The purpose of this study is to evaluate the investigational medication daraxonrasib in people with metastatic pancreatic cancer whose disease has progressed after previous treatment, who have no satisfactory treatment options, and who are unable to participate in a daraxonrasib clinical trial.
• 18 years of age or older able to take oral medication
• diagnosed with metastatic pancreatic cancer that has grown or spread after previous treatment
• received at least one prior treatment for metastatic pancreatic cancer
• see link to ClinicalTrials.gov for complete Inclusion Criteria
• pancreatic cancer that has spread to the brain or central nervous system
• currently receiving another cancer treatment
• significant heart disease or an active, uncontrolled infection
• major surgery within the past 28 days
• see link to ClinicalTrials.gov for complete Exclusion Criteria
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 Pilot Study of Treatment of Bone Metastases in Spine: Radio Frequency Ablation/ Bone Augmentation plus Radiotherapy Vs. Radiotherapy
This clinical study is for adults whose cancer has spread to the bones of the middle or lower back (spine). Doctors are comparing two common treatments: (1) a needle procedure to treat the tumor and strengthen the bone, followed by radiation, and (2) radiation therapy alone. The goal is to see which option better relieves pain, protects the spine, and improves quality of life. The treatment you receive will be chosen at random (by chance), meaning you will be placed into a study group by chance.
• confirmed metastatic disease in the thoracic or lumbar region of the spine
• associated bone pain
• persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• prior radiation therapy to the same area of the spine
• spine stabilization surgery is being considered
• see link to clinicaltrials.gov for complete Exclusion criteria
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
HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma
This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.
• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)
The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early Triple Negative Breast Cancer (TNBC) when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants with low tumor expression of the estrogen and/or progesterone receptors (1 to 10%) will also be included in this study. The study treatment will be chosen by chance—like flipping a coin. There is a 1 out of 2 chances to receive Sacituzumab govitecan in combination with Pembrolizumab and 1 out of 2 chances to receive a study treatment of study doctor’s choice of either pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants and their study doctor will know what study drug is being taken.
• invasive triple negative breast cancer (TNBC) still remains in the breast or lymph nodes after therapy and surgery
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma
This is an early study of a new drug, RGDCRAdCOX2F, as a single tumor injection in persons with adenocarcinoma of the pancreas. The main goal of the study is to find a safe dose of the study drug.
• documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes
• one prior line of therapy is permitted
• normal cardiac and pulmonary function
• participants with partners of childbearing potential must be willing to use at least two forms of effective birth control
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breastfeeding
• other types of pancreatic cancer
• history of human immunodeficiency virus (HIV) infection
• history of or active acute or chronic active hepatitis B or C infection
• taking 10mg/day or more of prednisone for more than one week
PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)
This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.
• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
MT2025-36: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
This study is about treatment of Melanoma (a kind of skin cancer) that has spread or cannot be surgically removed and has gotten worse after standard treatments. This study includes patients with melanoma from any part of the body except the eye. The main purpose of this study is to learn if the study medicine (tebentafusp), alone or a combination with pembrolizumab, helps patients with advanced melanoma live longer. The combination of pembrolizumab and tebentafusp used in this study is experimental.
• unresectable Stage III or Stage IV non-ocular melanoma
• may not be able to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• diagnosis of ocular or metastatic uveal melanoma
• history of a another type of cancer
• unable to be retreated with pembrolizumab because of a previous severe side effect
• significant pulmonary or cardiac disease or impaired lung or cardiac function
• known psychiatric or substance abuse disorders
• see link to clinicaltrials.gov for complete Exclusion criteria
Phase I Study of Peptide Alarm Therapy (PAT) Administered by Intratumoral Injection with a PD-1/PD-L1 Inhibitor in Patients with Solid Tumor Cancers Who Have Failed Two Prior Therapies
This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.
• positive for Cytomegalovirus (CMV) and Epstein–Barr virus (EBV
• failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).
• strenuous activity may be restricted; can do light work; able to walk
• people of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or use a highly effect form of contraception from the time of study enrollment until at least 4 months after the last dose study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breast feeding
• active metastases to the central nervous system
• active autoimmune disease that has required systemic treatment in the past 2 years
• history of bone marrow and/or solid organ transplant
• other active medical conditions
• see link to clinicaltrials.gov for complete Exclusion criteria