Search Results Within Category "Cancer"
PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER
The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.
Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
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
PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED
This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.
Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
A011801 THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB (PSCI# 21-155)
The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning
The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning.
ECOG Performance Status 0-1
Patients must have received neoadjuvant chemotherapy with one of the following regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P).
HER2-positive breast cancer per pathology
Prior treatment must have consisted = 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of = 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or FDA-approved biosimilars).
Patients with known active and/or untreated Hepatitis B or Hepatitis C or chronic liver disease are ineligible.
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
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
Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel toabiraterone acetate in patients with CRPC that have previouslyreceived docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.
Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate).
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer.
Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT).
Ability to swallow abiraterone acetate tablets as a whole.
Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate.
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy.
Any medical condition for which prednisone (corticosteroid) is contraindicated.
Active infection requiring treatment with antibiotics.
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.
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.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase.In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia.Induction Treatment Phase (1-3 months)•Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.Maintenance Treatment Phase (12 months)•Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor.Long-term Follow-up Phase (48 months)•Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.•Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
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
Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
PSCI# 23-137 NRGF-001: ACTIVITY MONITORING TO IMPROVE PATIENT CARE DURING CHEMORADIOTHERAPY FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (LA-NSCLC)
this trial looks at the difference in health between lung cancer subjects who do deliberate exercise measured by a fit bit and those who do not.
Participants will need to commit to all appointments. All those assigned to the fit bit arm must agree to wear it as instructed. You will wear the activity monitor for approximately 4 months. There are approximately 13 visits in total that you would need to come to the clinic.
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy.
Age ≥ 18
Ambulates independently or with a cane (use of a walker not permitted)
Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)
This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.
venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
UroGen UR001
This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body
If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
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
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)
This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs,height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.
70.00 per visit
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.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 approach increases the time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. But it could also cause side effects, which are described in the risks section below.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 approach increases the time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
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, andDexamethasone (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 freesurvival 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), ARANDOMIZED 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 appointmentsreport 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 to24 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 acomprehensive 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 weekso At 3 weeks and 6 months or discontinuation of treatment (whichever comes sooner) and atdisease progressiono Every 3 weeks: Approximately 1 tablespoon for tests that monitor your blood sugar levelsand thyroid functiono 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 oftreatment.Tumor biopsy will be optional for phase II patients..Safety Follow-Up:After all study treatment has stopped, end of treatmentvisit, which will be approximately 30 days after their last dose of study drug or before starting a newtreatment Medical History: Concomitant medications complete physical examination ECOG Performance Status Perceived Stress Scale assessment Adverse events Survival status Blood tests:o Follow- Up Phase3 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
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
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