Search Results Within Category "Cancer"
Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.
We are asking you to give permission for your doctor to send your stored tumor tissue sample for cancer genetic analysis. As part of your cancer care, your doctor may have already collected a tumor tissue biopsy sample (of your cancer tissue) in the past, recently, or being planned as part of standard medical care. Your doctor will ask for any of your stored or available tumor tissue sample collected elsewhere from previous doctors you may have seen in the past. We will not ask you to undergo a new tissue biopsy procedure for this testing however your treating physician may decide to do so as part of your standard of care. There is no required visit for this testing. Once you have signed this consent, your available tumor tissue sample from a prior biopsy or surgery along with the pathology report will be sent to an accredited and certified external genetic laboratory (such as Caris Life Sciences or Interpace Pharma Solutions) to test and understand your cancer’s genetic make-up. The use of your tumor tissue samples as described in this form is necessary for the genetic testing. Without your consent to test your samples, the genetic testing cannot be performed. Once you agree to provide your samples, they cannot be returned to your doctor’s clinic. If the genetic testing of your samples show you have c-MET genetic dysregulations in your cancer, your doctor will discuss your treatment options including clinical trials, such as the APL-101-01 SPARTA trial, with you. If you are interested in participating, you will be asked to review and sign another participant information and informed consent form for the clinical trial before undergoing further screening tests to confirm if you are eligible to participate. The genetic results could also be used to help your clinic doctor decide on an approved therapy, or other investigational therapies that may be right for your specific cancer genetic alterations.
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
PSCI 23-145 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
This trial is comparing two different therapies for the treatment of newly diagnosed multiple myeloma who are not having a bone marrow transplant.
Subjects will be required to keep all research visits, take medications as directed, report any new medication of side effects to the study team,
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
Patient must agree to register to the mandatory Celgene Revlimid REMS program and be willing and able to comply with the requirements of the Revlimid REMS program.
Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.31
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
Patient must not have peripheral neuropathy ≥ Grade 2 on clinical examination or grade 1 with pain
PSCI# 18-127 EA6174 Adjuvant MK-3475 to SOC
The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.
We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
PSCI 23-035 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
This trial will compare two different drug combinations known for treating multiple myeloma by adding two new drugs to those existing combinations (talquetamab and Teclistamab)for multiple myeloma patients
Participation will be at least three months or until the medication stops working. You will need to come to the clinic every week for the first cycle of medication for lab work, a physical exam, EKG and vital signs and for the study doctor to see how you are feeling. After that you will come in every other week for treatment. You will see the study doctor and have a physical exam, blood tests and other evaluations to make sure that you are okay,.
$57.00 per completed visit. $14.00 for a caregiver to come with you.
have a diagnosis of Multiple myeloma
Measurable disease at screening
Relapsed or refractory disease
Negative serum or urine pregnancy test within 24 hours prior to the start of study treatment
A participant must agree not to plan to father a child while enrolled in this study or within 6months after the last dose of study treatment.
Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment
Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF
PSCI 23-023 A PHASE III, MULTICENTER, RANDOMIZED, OPEN‑LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLA‑R‑CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA
To see if using glofitamab added to chemotherapy is better than chemotherapy alone.
Participants will be required to come to all study visits, report any new medications, prescription or over the counter that they are taking, make sure to tell the study doctor of any new symptoms you may be having.
$180/visit, $130 follow up visit
Previously untreated participants with CD20-positive LBCL
IPI score 2-5
ECOG Performance Status of 0, 1, or 2
Life expectancy >/= 6 months
Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
receiving systemic immunosuppressive agents
Significant or extensive history of cardiovascular disease
PSCI 21-191: CG-745-2-08
The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.
Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (PSCI# 21-115) (EAA173).
The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups. Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma. It is not, however, approved for treatment of smoldering multiple myeloma, either alone or when combined with the treatment regimen of lenalidomide and dexamethasone, and therefore is considered experimental. Lenalidomide and dexamethasone are approved for treatment of multiple myeloma (symptomatic) but not for the treatment of smoldering multiple myeloma and therefore is also considered an experimental treatment.
We are asking you to take part in a research study because you have high-risk smoldering multiple myeloma. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Patient must have adequate organ and marrow function.
Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.
Concurrent use of erythropoietin is not allowed while on study therapy.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Patients with monoclonal gammopathy of undetermined significance are not eligible.
Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
PSCI# 19-005 EA9161
The is a drug study to compare the progression free survival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
PSCI 24-015 S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET), A RANDOMIZED PHASE III STUDY
To see if participants with early stage triple negative breast cancer randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have a better breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.
keep all study appointments report to your study team any side effects or any changes in medication
Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization.
Participants must not have metastatic disease
Participants must not have received prior systemic therapy or radiation therapy
Participants must be ≥ 18 years old.
Participants must not have a prior or concurrent malignancy
Participants must not have received a live vaccine within 30 days prior to randomization.
Participants must not have active autoimmune disease
Participants must not have severe or active infections
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.
Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma
This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Phase II *propranolol twice a day. *pembrolizumab by an infusion every 3 weeks. *May receive treatment with pembrolizumab and propranolol for up to 24 months from the time they began treatment with the combination. Procedures to be done:. A medical history A physical exam ECOG Performance Status Perceived Stress Scale questionnaire An assessment of tumor by scan. Scans may include: o Computed tomography (CT), with or without contrast. o Magnetic resonance imaging (MRI) or head CT with IV contrast Blood tests: o Approximately 2 tablespoons for routine testing, such as a complete blood count and a comprehensive metabolic panel Pregnancy test Urinalysis Electrocardiogram A sample of tumor from a previous biopsy or sample taken Phase 1 portion of the study, these evaluations/tests will also occur on Day 8 of Cycle 1 Review concomitant medications. Physical Exams ECOG Performance Status Perceived Stress Scale questionnaire Blood tests: o Every 3 weeks o At 3 weeks and 6 months or discontinuation of treatment (whichever comes sooner) and at disease progression o Every 3 weeks: Approximately 1 tablespoon for tests that monitor your blood sugar levels and thyroid function o Every week for the first 6 weeks then every cycle for another 6 weeks Assessment of cancer by CT or MRI. These assessments will be performed every 12 weeks(± 14 days). The first assessment will be after completing Cycle 4. If their cancer is found to be improving, repeat the CT and MRI scans in about 12 weeks. EKG: Once treatment begins, this will be done every cycle prior to receiving pembrolizumab for the first 5 cycles. Adverse events Tumor Biopsy: A tumor biopsy (only in phase II) will be obtained at the 12 weeks after initiation of treatment.Tumor biopsy will be optional for phase II patients.. Safety Follow-Up: After all study treatment has stopped, end of treatment visit, which will be approximately 30 days after their last dose of study drug or before starting a new treatment Medical History: Concomitant medications complete physical examination ECOG Performance Status Perceived Stress Scale assessment Adverse events Survival status Blood tests: o Follow- Up Phase 3 Month and 6 Month Follow- up After Treatment blood collected. The following assessments will be performed at 3 months and 6 months after the safety follow-up visit. Review concomitant medications Physical examination ECOG Performance Status Adverse events Survival Status Blood tests: CT of chest, abdomen and pelvis, or other areas as needed Long Term Survival Follow- Up: After your 3 month and 6 month follow up visits or if they progress, will be contacted every 6 months (±30 days)
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes
The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.
The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 3 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. • The survey will take approximately 10 minutes of your time. • Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so. • At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.
Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).
Over the age of 40
English Speaking
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTION RADIATION FOR HIGH-RISK PROSTATE CANCER
This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.
Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma
This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
PSCI# 25-028 LoTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER
This study is comparing standard of care endocrine therapy for 5 years versus low dose tamoxifen for 5 years in patients with resected invasive breast cancer.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling.
No tumors that are considered pT4
No definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18 years and female ___
ECOG Performance Status ≤ 2
Any patient with known atypia or endometrial pathology that the opinion of the treating investigator would place the patient at undue risk of endometrial cancer with tamoxifen
Any patient with a known hypercoagulable state that in the opinion of the treating investigator would put the patient at undue risk of venous thromboembolism with tamoxifen.
No synchronous or previous contralateral invasive or non-invasive breast
No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS, regardless of the disease-free interval.
PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.
Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years. After you finish your study treatment, doctor will continue to follow condition for 10 years.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
PSCI 24-129 Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies
This trial will examine the use of "off the shelf" CAR T in the treatment of cancers that have relapsed or do not respond to treatment.
Participants must keep all study visits, tell the study doctor how you are feeling and all medications you are taking including over the counter medications.
Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL, and tFL or follicular lymphoma Grade 3B.
Must have relapsed/refractory disease
Must be willing to practice birth control
Concurrent or previous other malignancy within 2 years of study entry
Has active autoimmune disease
Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection
PSCI 24-106: Myelomatch, Master Screening And Reassessment Protocol (MSRP) For Tier Advancement In The NCI Myelomatch Clinical Trials
The purpose of the study is to see if blood and bone marrow samples can be tested in a timely manner for markers that could guide cancer treatment. The testing will look for markers that specific treatments may target. Based on test results, the subject will have the option to join a myeloMATCH treatment substudy for treatment or receive standard of care treatment from your doctor.
Participants will give bone marrow and blood samples for testing. Your samples will be tested for specific cancer biomarkers. After the study receives the results of your biomarker testing, the physician will tell you if there is a myeloMATCH treatment substudy available that matches your results. If a substudy is available the study doctor will give the subject more information about it and help the subject understand the details of the study.
Participants must be ≥ 18 years of age.
Participants must agree to have translational medicine specimens submitted per
Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration
Participants are less than 18 years of age.
Participants did not agree to have translational medicine specimens submitted per
Participants have a prior or concurrent malignancy that requires concurrent anti-cancer therapy.
Participants did not have a Zubrod Performance Status evaluation within 28 days prior to registration
PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).
This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.
Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
PSCI 24-106: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial
This study is being done to answer the following question: Can we shrink the amount of AML or get rid of it in your bone marrow and body by treating you with the standard approach of cytarabine + daunorubicin (7+3) or one of the following experimental groups: 1) cytarabine and daunorubicin with venetoclax 2) azacitidine and venetoclax, 3) daunorubicin and cytarabine liposome, or 4) daunorubicin and cytarabine liposome with venetoclax? Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants must have high-risk (adverse) AML per ELN 2017 criteria.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants with favorable or intermediate risk disease are excluded.
Participants with FLT3 mutations (ITD or TKD) are excluded.
Participants with t(9;22) translocation are excluded.
NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
This study is being done to answer the following question: Will preventative radiation therapy lower the number of bone metastases-related complications (such as fracture caused by the tumor in the bone and tumor pushing on the spinal cord) compared to the usual approach? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for high-risk bone metastases that are not causing symptoms.
If the participant decides to take part in this study, they will either get the usual approach or they will get radiation therapy for up to 5 days plus the usual approach. After the participant finishes treatment, the doctor and study team will continue to follow their condition and watch for side effects. The doctor and study team will check the participant 3, 6, 12, and 24 months after they join the study.
“High-risk” asymptomatic bone metastasis(es)
Patients with any solid tumor type (excluding multiple myeloma)
Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body PET/CT, with radiology report available.
Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment.
Uncovering Barriers in Clinical Trials for Cancer Care in the Penn State Cancer Institute patient population – survey feasibility study
This a pilot study that will evaluate the feasibility of assessing perceived barriers to accessing clinical trials in the PSCI patient population through a questionnaire.
Patient need to fill out a survey about accessing clinical trials to the best of their ability.
Speak and write English
Have a history of cancer (both liquid and solid tumors)
Currently receiving or have received any form of systemic therapy for cancer at PSCI
Be treated at least in part at Penn State Hershey Cancer Institute for cancer
PSCI 24-073 TRANSPARENT: Single-Arm Study of Toripalimab in Combination with Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor. Although toripalimab is approved for the treatment of NPC, it is not approved to be used with these other two drugs.
Participants will be required to come to all study visits. At those visits the following may occur, blood tests to see if you are well enough to participate or continue to participate in the trial, a physical exam by the study doctor, meeting with the study team to talk about how you are feeling followed by getting toripalimab and chemotherapy. At other time you will need to have scans to see if how your cancer has responded to the treatment. These visit will continue until your cancer grows back, doesn’t respond to the treatment or the study is stopped by the sponsor.
Recurrent/metastatic or recurrent NPC after curative treatment.
Measurable disease
Prior therapy administered in the recurrent or metastatic setting
Rapidly progressing disease
PSCI #24-133 A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer
this trial will see if using Rina S is better in treating ovarian cancer than standard treatment.,
Participants will need to come in for all study visits, take the medication as instructed, report all side effects and all medications including over the counter ones to the study team.
must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Patients must have received 1 to 4 prior lines of therapy.
Known active central nervous system metastases or carcinomatous meningitis
Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days
PSCI 24-132 A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
This trial will examine the outcome of comparing Sonrotoclax Plus Zanubrutinib vs. Zanubrutinib alone in the treatment of mantle cell lymphoma
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
Received 1 to 5 prior lines of systemic therapy
Relapsed or refractory disease after the last line of therapy
Age ≥ 18 years.
Prior allogeneic stem cell transplant within 6 months of the first dose of the study treatment
Known central nervous system involvement by lymphoma
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
This study is for participants who have a brain tumor and decide with their doctor to use GammaTile radiation therapy to treat their brain tumor. This treatment is FDA approved. The purpose of this study is to collect data on how this treatment impacts your health and wellbeing.
There are no required visits or treatments for this study. At your regularly scheduled doctor visits, your study doctor or staff will enter relevant health and medical information into the study database. You will also be asked to complete questionnaires about the quality of your life during your routine medical appointments.
Willing and able to provide informed consent and to participate in all evaluations.
Major medical or psychiatric illness, which, in the investigator’s opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
Lack of English or Spanish language fluency sufficient to allow for providing informed consent and for completion of QOL tests all of which are available in English and Spanish.
PSCI 23-125 A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
This study is loking at how a new drug treats breast cancer. The breast cancer must have the following genetic mutations BRCA1, 2 or PALB2
You will need to come to all the study visits, take the study medication as prescribed, tell the study doctor about all medications you are taking, including over the counter and to tell the doctor how you are feeling.
Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease.
Minimum life expectancy of 12 weeks.
Participants with any known predisposition to bleeding
any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
active and uncontrolled hepatitis B and/or hepatitis C.
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
AHOD2131:A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab. This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma.
Consent to treatment, required labs and imaging, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)) with Stage I or II disease
Patients must have bidimensionally measurable disease (at least one lesion with longest diameter ≥ 1.5 cm)
Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained.
Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright PA CXR for assessment of bulky mediastinal disease.
Patients with a history of active interstitial pneumonitis or interstitial lung disease
Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
Patients with peripheral neuropathy > Grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome.
Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
AAML1831: A study to compare standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed AML with or without FLT3 mutations
This phase III trial compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) 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, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification152 with or without extramedullary disease.
All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831.
Patients with persistent cardiac dysfunction prior to enrollment
Pregnancy and Breastfeeding