Search Results
Randomized Phase III Trial of MEDI4736 (durvalumab) asConcurrent and Consolidative Therapy or ConsolidativeTherapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041).
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
Patient must have an ECOG Performance Status of 0 or 1.
Body weight > 30 kg of patients.
Patient must not have unintentional weight loss > 10% within 30 days prior to registration.
Patient must have a baseline ECG obtained within 6 weeks of registration.
Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection.
Patient must not have a known active tuberculosis infection.
Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors (ELVCAP-001-01)(20-095)
Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors
Most of the examinations, tests and procedures are part of the usual approach for your cancer. However, there will be extra procedures like blood draws and additional tests on your tumor to determine if your condition is suitable to take part in this study.There are three stages to this study: Screening, Study Treatment period, End of Study Treatment/Follow-up.
Availability of fresh or archived tumor sample
Minimum of one prior standard therapy appropriate for their tumor type and stage of disease, progressed or been nonresponsive to these available therapies
ECOG performance status 0, 1 or 2
At least one measurable extra-cranial lesion
Life expectancy < 3 months
Pregnant or lactating
Symptomatic or untreated brain metastases
Known hypersensitivity to any of the components of seribantumab
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)
Repotrectinib for cancer that has returned or is not responding to treatment
If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.
You are positive for certain changes in your genes which we will test you for as needed
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).
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Phase 1/2 Study to Evaluate Palbociclib (IBRANCE®) in Combination with Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors
A study of the safety of palbociclib with irinotecan and temozolomide and palbociclib with topotecan and cyclophosphamide for children with solid tumors that returned or did not respond to previous treatment.
If you join the study, you will be assigned to receive either palbociclib in combination with backbone chemotherapy of IRN and TMZ or the backbone chemotherapy (IRN and TMZ). You may be asked to provide biological samples (such as blood or urine or tumor tissue sample) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will be required to visit the study doctor on days 1 to 5 of each 21-day cycle and on day 14 for the first 2 cycles to undergo study assessments and to provide information about your health.
Ages ≥2 and <21
PSCI 22-156 HCRN BRE17-141
The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.
Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (MRT849-001)
This study is to determine the maximum tolerated dose (MTD) of MRTX849 using one or more dosing regimens. The regimens includ using MRTX849 or in combination with Afatinib, Cetuximab, or Pembrolizumab. The study will also look at how it can be tolerated MRTX849 when its taken with food.
If you take part in this research, your major responsibilities will include: •Keep your study appointments and complete all study assessments. If you cannot keep anappointment, please contact study personnel (your study doctor or study staff) as soon aspossible to schedule a new appointment.•Inform your study personnel about any symptoms, changes in medications, doctor's or nurse'sappointments, or hospital admissions that you may have had.•Agree to not participate in any other clinical research study•Inform study personnel if you believe you or your partner might be pregnant•Inform study personnel if you change your mind about participating in the study.•Inform your other doctors that you are taking part in this study.•Avoid grapefruit and grapefruit juice.•Avoid herbal medications and preparations including but not limited to St. John’s wort, Kava,turmeric/curcumin, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA),yohimbe (yohimbine), saw palmetto, and ginseng.•Avoid medications that are processed by liver enzymes, your doctor will counsel you on these.•Avoid medications known to have risk of changing the electrical activity in the heart, your doctorwill council you on these.•For your safety, you must tell the study doctor or nurse about all the prescription drugs, herbalproducts, over-the-counter drugs (OTC), vitamins and other supplements you are taking.Check with the study doctor before starting any new medicines (including prescription, OTCdrugs, vitamins and herbal supplements) or changing doses of medications that you arealready taking.
Unresectable or metastatic disease.
Presence of tumor lesions to be evaluated per RECIST 1.1:
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1.
Patients with carcinomatous meningitis
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose date
Undergone major surgery within 4 weeks of first dose date
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications
Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer (PSCI# 21-217) (NRG-GU010)
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score.If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
ECOG Performance Status of 0-2 within 120 days prior to registration;
For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
Previous bilateral orchiectomy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Inability to swallow oral pills.
A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor (PSCI# 21-039)
The purpose of the dose-escalation part is to evaluate GEN1046 in subjects with solid malignant tumors to determine the maximum tolerated dose (MTD) or maximum administered dose and/or the recommended phase 2 dose (RP2D). The purpose of the expansion part is the further evaluate the safety, tolerability, PK and antitumor activity of the selected dose(s) in select solid tumors.
The participants will be required to follow the trial doctor's instructions, have tests and checks done as part of the trial, inform the trial doctor of any changes in how they are feeling, be open and honest about their health history, inform the study team of all concomitant medications, and inform the trial doctor if you decide not to participate in the trial anymore.
Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 monoclonal antibody (mAb)
Subject must have tumor PD-L1 expression of tumor proportion score (TPS) >= 1%
Subject must have measurable disease per RECIST v1.1
Subject must have Eastern Cooperative Oncology Group (ECOG) PS <= 1
Subject has been exposed to prior treatment with docetaxel for NSCLC
Subject has been exposed to prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine or autologous cell immunotherapy
Subject has been exposed to treatment with an anti-cancer agent within 28 days prior to GEN1046 administration
Subject discontinued treatment due to disease progression within the first 6 weeks of a CPI-containing treatment
A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.
If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
You will need to have the following extra exams and tests to find out if you can be in the research study:•Electrocardiogram (EKG) to check your heart rhythm•Blood or urine pregnancy test, if you are a woman of child-bearing potential•Smoking status survey•ALK Fusion Status test using tissue from your previous surgery and/or biopsiesToxicity assessment will be done every 3 weeks for the first 6 weeks, then every 6 weeks for the next 12 weeks, then every 12 weeks until treatment is completed.
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
A Phase I/II, Multicenter, Open Label, Multi Arm Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Preliminary Activity Of Idasanutlin In Combination With Either Chemotherapy Or Venetoclax In The Treatment Of Pediatric And Young Adult Patients With Relapsed/Refractory Acute Leukemias Or Solid Tumors
A study of the safety of idasanutlin for children with solid tumors and leukemias that returned or did not respond to previous treatment.
You will be expected to take your assigned study drug combination (either idasanutlin and venetoclax or idasanutlin and chemotherapy). You will also need to come to all study visits as possible. You will need to make sure you are not in another research study, and that you will take all of the required precautions agaiinst pregnancy.
Have a solid tumors or leukemia that returned or did not respond to previous treatment
Have uncontrolled infection
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial
This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
Patients will have to sign the consent form to participate in the trial
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/Refractory Solid Tumors
Neratininb for childhood cancer that has returned or is not responding to previous therapy
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
PSCI 22-114: A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF NKTR-255VS PLACEBO FOLLOWINGCD-19 DIRECTED CAR-T THERAPYIN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA.
This is a drug study that will evaluate how well the investigational drug works compared to a placebo following CAR-T cell therapy. Participants will be required to keep all your scheduled visits, receive drug treatment, blood draws, imaging, and possibly a tumor biopsy.
Participants will be required to receive the study treatments including CAR-T infusion, blook tests, imaging, tumor biopsy, and study medications.
Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only)
Received lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
Fluorodeoxyglucose (FDG)-avid disease on PET imaging within 30 days prior to CAR-T cell infusion
FDG avid lesion(s) on PET/CT scan following bridging therapy and prior to lymphodepletion, where applicable.
Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
Known human immunodeficiency virus (HIV) infection
An Intermediate Expanded Use Trial of DFMO(eflornithine HCl)
This research study is to provide expanded access to a new investigational drug DFMO (difluoromethylornithine) for patients with neuroblastoma, medulloblastoma, and certain rare tumors that have no other curative options. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
If you are enrolled on this study, DFMO will be started in clinic on Day 1. After this first day you will be seen in clinic approximately once every 30 days for the first 6 months of study and once every 90 days for the last 18 months of study. These visits will last about 2 hours, and involve a physical exam, blood tests, and other testing.
Not eligible for DFMO studies NMTRC014, BCC015, or BCC016
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF 1R, in Newly Diagnosed Patients With Glioblastoma
The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo (only standard of care) to see if it works in slowing GBM tumor regrowth.SOC refers to the usual medicine(s) or procedures used to treat this cancer.
You will be randomly assigned by chance, like rolling a pair of dice - to receive either IGV-001 or placebo (inactive substance) that will be placed into biodiffusion chambers [dime-sized containers] and surgically implanted in your belly area for approximately 48 hours and then removed. You will have a 66.6% (2 in 3) chance of receiving IGV-001 and a 33.3% (1 in 3) chance of receiving placebo. There is a small chance that you may not receive treatment with IGV-001 or placebo after the abdominal incisions have been made.
Is between 18 and 70 years of age at screening
Has a diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement defined using the patient’s symptomology, MRI scan results, and intraoperative frozen section verbal confirmation of malignant glioma.
Has adequate bone marrow and organ function at screening
Has received any previous surgery for tumor removal of GBM
Has recurrent glioma, a concurrent malignancy
Has any severe immunocompromised condition
Is receiving any other investigational agent(s) or has received an investigational agent within 30 days prior to screening
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.
If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.
A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma
This study is being done to learn if it is safe to add naxitamab to standard therapy during the Induction phase of care for patients with newly diagnosed high-risk neuroblastoma. Naxitmab is an immunotherapy agent which trains your immune system to target your tumor in a more specific way than chemotherapy does.
This study has 3 phases- screening, treatment, and follow up. If you join the study, during screening we will test a sample of your tumor along with your blood. The tumor sample will be obtained at the same time as you are having surgery or a biopsy. Other testing will be done to make sure you are eligible to receive treatment. If you are eligible for treatment, you will receive five 21 day cycles of anti-cancer medication (induction chemotherapy) along with naxitamab. You will have to stay in the hospital to receive this treatment for at least 6 days of each 21 day cycle. If your screening testing also shows a certain genetic change in your tumor, we may also add a medication that is targeted at that change. If your tumor does not respond adequately to the initial cycles, we may give up to three additional 21 day cycles of chemotherapy with naxitamab. You will also have procedures at certain timepoints during induction that are standard of care for your tumor. These include collecting stem cells for use later in your therapy after Cycle 2. After Cycle 4, you will have surgery to remove as much of the tumor as possible. The treatment phase will last about 8 months, after which you will be in follow up. During your time on the study, we will ask to collect research samples of blood, bone marrow, and tumor. We will be monitoring your progress and health throughout your time on treatment and in follow up.
≤ 21 years of age at initial diagnosis and > 12 months of age at time of enrollment
Receiving any investigational drug
PSCI 22-132 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
The purpose of this voluntary research study is to evaluate potential new anticancer to treat people with tumors similar to yours. This study will provide information about the safety, the ability of your body to accept the study drug(s), the amount of study drug(s) and/or break-down products in your blood, and your body’s reaction to the study drug(s). Participants will be required to take study medication, have blood drawn, and have imaging tests such as CT, MRI, ECG, MUGA, ECHO, and bone scans.
Participants in the expansion stage will receive study treatment, imaging exams (ECHO, MUGA, ECG, CT, MRI, bone scans), blood draws, tumor assessments, and tumor tissue samples.
For all Expansion Cohorts except Cohort 3 (mCRPC): Measurable disease per RECIST
For Expansion Cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent
Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), and Cohort 10 (CRC, 2L+): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
Genomic Profiling of Urothelial Cancers Study
The objective of this protocol is to study urothelial cancer with detailed health history, tumor and/or normal tissues available for genomic sequencing to study cancers in the bladder, upper urinary tract, and urethra. There will be 3 groups of subjects in this study:1)Urothelial cancer patients receiving care at Penn State Health2)Relatives of patients with urothelial cancer3)High risk-cohort of individuals with family history of urothelial cancers or inherited cancer syndromes (such as Lynch syndrome) candidates for urothelial cancer screening evaluation
All subjects will be asked to fill out questionnaires to assess risk factors for urinary cancer and document family history of cancer. You will be asked to provide a blood sample and urine sample for genetic testing. Patients with urothelial cancer will be asked to allow us to test leftover tissue from a past or future biopsy to test cancer and/or normal cells for certain mutations. We may also ask you for a saliva sample, cheek swab, skin biopsy, or nail clippings for comparison.
personal or family history of bladder cancer
Precision mEdicine and Adoptive Cellular tHerapy for the treatment of recurrent neuroblastoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG)
This study is being done to learn if a vaccine made in the laboratory from your tumor and your immune cells is safe to give to you to treat your tumor. It is believed that the body’s immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use your tumor and immune cells from your blood to make a vaccine that we hope will stimulate your T-cells to kill tumor cells and leave your normal cells alone.
You will need routine (standard of care) testing for your tumor, as well as research tests and procedures including further analysis of your tumor sample, generation and review of a personalized genetic report, and procedures to collect certain cells for different infusions and creation of specialized cellular vaccines. You will then be offered and placed on a treatment plan. As a subject in this study you will remain in this study until you complete vaccine therapy as long as you have no disease progression or unless you need to come off study for another reason.
For Neuroblastoma must be >12 months and ≤ 30 years of age
For DIPG must be ≥ 3 years and ≤ 30 years of age
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection
PSCI 23-008: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status ACR-368-201/GOG-3082
This trial will be looking at patients with OncoSignature positive and negative tumors using the treatment of the study drug in combination with ultra low dose gemcitabine.
If you are in Arm 1, you will receive ACR-368 as a single intravenous (in the vein) infusion over approximately 60 minutes twice during a 4-week period, on Days 1 and 15. This entire 4-week period is called a cycle. If you are in Arm 2, you will receive gemcitabine and ACR-368 as two separate intravenous (in the vein) infusions. The gemcitabine infusion will last approximately 30 minutes and the ACR-368 infusion will last approximately 60 minutes. •Biopsy Sample and OncoSignature® Status•Archived Tumor Sample and Genomic Information•Physical Exam•Pregnancy Test if applicable•Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan•Blood Sampling for CA-125 (Ovarian carcinoma only)
Subject must have histologically confirmed, locally advanced (ie, not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
Subject must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator)
Subject must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent.
Subject must have an estimated life expectancy of longer than 3 months.
Subject has a history of clinically meaningful coagulopathy, bleeding diathesis.
Subject had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
Subject with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent).
Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.
PSCI 23-144 NRG-LU008: PHASE III PROSPECTIVE RANDOMIZED TRIAL OF PRIMARY LUNG TUMOR STEREOTACTIC BODY RADIATION THERAPYFOLLOWED BY CONCURRENT MEDIASTINAL CHEMORADIATION FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER
Patients diagnosed withy inoperable node positive non small cell lung cancer will be randomized to with radiation therapy to all know sites of disease in the lung, followed by immunotherapy or radiation to the primary lung tumor, followed by radiation to the lymph nodes followed by immunotherapy
Participants will be required to come to all study visits, report to the study doctor any new medications, prescription or over the counter that they may be taking,
The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
No evidence of distant metastases based on FDG PET/CT scan obtainedwithin 60 days of registration.
Primary tumor ≤ 7 cm;
Age ≥ 18;
Patients without identifiable primary tumor
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields
Participants who are pregnant or unwilling to discontinue nursing.
Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis