Search Results
PSCI-23-089: CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II study
Researchers in this trial will be using a combination of two drugs to determine if the combination will help in treating cancer by shrinking tumors and controlling cancer growth.
You will need to come to the clinic for at least six visits while you are taking the study medication. Those visits will include see the study doctor, having blood drawn, and giving you the study drug. When you are no longer taking the study drug you will be seen about 2 months after that followed by phone follow ups between 6 and 8 months after stopping the study drug and then every year for 2 years. Those yearly visits can also be done by looking at you medical record.
Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer.
Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
Life expectancy of at least 6 months
Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease.
Has uncontrolled diabetes.
Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment.
Is pregnant or breast feeding.
Has drug-induced pneumonitis ( e.g. from amiodarone, methotrexate or nitrofurantoin)
PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA
This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab
Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.
$202 for each visit completed
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
PSCI: 24-010: Evaluate Safety and Efficacy of Daily oral Angelica gigas Nakai (AGN)-INM176 in Prostate Cancer Patients with Rising Plasma PSA (Phase I/II trial)
The purpose of this voluntary research study is to evaluate the safety and assess the efficacy of the daily INM176 herbal supplement in managing prostate cancer-specific PSA levels in prostate cancer patients.
This research study involves two phases: Phase I and Phase II. The procedures and treatments may vary depending on the phase the participant is in. Study Drug is administered daily by mouth. Pharmacokinetic (PK) and Pharmacodynamic (PD) blood tests are research procedures. Other research procedures include physical exams, vital signs, and blood tests.
total of $1300 and $1200, respectively
Male aged >=40 years.
History of prostate cancer diagnosis
Subjects with treated prostate cancer are eligible.
ECOG performance status 0-2.
Any active secondary malignancy requiring treatment.
Chronic kidney disease with calculated GFR <30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR <30 mL/min/1.73 m2 using a 24-hour urine collection.
Subjects who are taking Warfarin/coumadin.
Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor
In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
BCC015: Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma that has returned or not responded to treatment. 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.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as CT scans and MIBG or PET scans. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
PSCI# 18-049 A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
A Phase II/III Study of Maintenance Nivolumab versus Observation in HPV Positive OPCA (PSCI# 20-016) (EA3161)
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from returning. 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 than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences
PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
A082002 Randomized Phase II/III of immunotherapy with or without SBRT PD-L1 negative NSCLC (22-026)
To assess if SBRT improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage NSCLC patients with PD-L1 TPS <1% who receive immunotherapy with or without chemotherapy
We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
No prior systemic chemotherapy or immunotherapy for advanced NSCLC
Not pregnant and not nursing
No known history of Hepatitis B or Hepatitis C
Platelet Count ≥ 100,000/mm3
Current pneumonitis or history of non-infectious pneumonitis that required steroids
Prior allogeneic tissue/solid organ transplant.
Age < 18 years
ECOG Performance Status over 3
Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (PSCI# 21-207) (NRG-HN009)
The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks.The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach.There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.
Age ≥ 18
Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration
Adequate hematologic function within 30 days prior to registration
Adequate renal function within 30 days prior to registration defined as calculated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula
Definitive clinical or radiologic evidence of distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnancy and individuals unwilling to discontinue nursing
BCC018: 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
BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.
RAndomized Phase II/III Trial Of Consolidation Radiation + Immuno-therapy for ES-SCLC (PSCI# 20-118) (NRG-LU007)
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The addition of radiation to the usual treatment could shrink your cancer or prevent it from returning. 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 life of patients or extends your time without disease compared to the usual approach.
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment.
measurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease at enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody
ECOG Performance Status of 0-2 at the time of registration
Age ≥ 18
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration
Patients who have had immunotherapy-induced pneumonitis
History of recent myocardial infarction within 6 months prior to registration
Phase II, questionnaire for “BRITE Synergy: Developing and Validating a Framework for Measuring Resilience in Low-Income Housing in the Post-Pandemic World”
This study includes the questionnaire related to "BRITE Synergy: Developing and Validating a Framework for Measuring Resilience in Low-Income Housing in the Post-Pandemic World" which has been previously submitted. The objective of this part of the research is examining the extent to which energy burden linked to the use of inefficient appliance within the context of a changing climate can be a good proxy for community resilience and if the ongoing building electrification drive.
Participants will be asked to complete an online survey via a link that will be accessed.
10 random participants will receive $20 gif cards.
Subjects must be living in the US
Living outside the US
PSCI 24-114: A Phase II Study Of Tailored Adjuvant Therapy In Pole-Mutated And P53- Wildtype/NSMP Early-Stage Endometrial Cancer (Rainbow Blue & Taper)
This study is to find out if there are types of early-stage endometrial cancer that require less treatment than the usual approach. Based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor may recommend Sub-study A or Sub-study B. Based on this assessment, subjects may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of your usual treatment.
Treatment that will be recommended to the subject will be based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor might recommend that the subject participate in Sub-study A or Sub-study B. Based on this assessment, the subject may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of their usual treatment After the subject finishes study treatment, and even if they stop treatment early, the study doctor will continue to follow the subject's condition, watch the subject for side effects and keep track of the subjects health. The subject will be seen after 3 months and 6 months, then every 6 months for 3 years, and then every year after starting the study until the study closes. The subject may be seen more often if subject's study doctor thinks it is necessary.
Patients’ Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
Patients’ age must be greater than18 years.
Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Prior pelvic radiation.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)
The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or returning. 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 be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to registration
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
A Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16 Positive Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
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.
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 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
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 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
PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma
This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
PSCI 24-106 A: A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial
As part of the myeloMATCH Older Adult AML basket, a comprehensive geriatric assessment will be implemented across intensive and non-intensive treatment studies to validate measures of fitness and frailty that predict for treatment-related morbidity and mortality. The overall goal of the geriatric assessment will be to validate measures to be incorporated in future older adult AML myeloMATCH studies to prospectively define “fitness” for intensive chemotherapy.
Subject will either get Azacitidine through a vein in their arm or subcutaneously and Venetoclax by mouth for up to 2 years, or will get Azacitidine through a vein in your arm or subcutaneously, Venetoclax and Gilteritinib as tablets that you take by mouth for up to 2 years.After you finish your study treatment, doctor will continue to follow condition for 10 years.
Patient must have no prior therapy for AML with the exception of hydroxyurea and all-trans retinoic acid (ATRA), or leukapheresis. Patients with cytarabine-based emergency therapy prior to the start of therapy on this trial are eligible.
Patient must be assigned to this protocol by the myeloMATCH MSRP.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
Creatinine clearance of ≥ 30 mL/min/1.73m2
Patient is pregnant or breast-feeding
Patients with a history of hepatitis C virus (HCV) infection have not been treated and cured.
Patient has the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug.
PSCI 24-106 B: A Measurable Residual Disease (MRD) Focused, Phase II Study Of Venetoclax Plus Chemotherapy For Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 Myelomatch Clinical Trial
Participants take part in this research study because they have a new diagnosis of acute myeloid leukemia (AML). Study is looking at to see if treatment can be improved by adding venetoclax to the usual chemotherapy: cytarabine and daunorubicin (also known as 7+3), or azacitidine? This study wants to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for AML.
Participants will either get cytarabine + daunorubicin + venetoclax for up to 11 days, or you will get azacitidine + venetoclax for up to two months, or you will get cytarabine + daunorubicin for up to 7 days. Subjects treatment may be extended by a few weeks if subject needs additional therapy. Doctor will continue to follow your condition for 5 years and watch subject for side effects and keep track of their health. After study treatment, subjects may also be offered another clinical trial through the myeloMATCH study. Subjects will be followed on this study even if they continue onto another study. Follow-up includes a clinic visit 28 days after subjects treatment is complete, and clinic visits every 3 months for the first year, every 6 months for the second year, and annually for years 3-5 after treatment is completed.
Participants must have been registered to Master Screening and Re-Assessment Protocol
Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow
ECOG performance status ≤ 3.
WBC must be <25x109/L.
Patients who are receiving any other investigational agents.
Pregnant women are excluded
Patients with isolated myeloid sarcoma are not eligible
active, uncontrolled bacterial, fungal, or viral infection
PSCI 24-106: A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) Vs (Daunorubicin And Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, And (Daunorubicin And Cytarabine) Liposome + Venetoclax In Patients Aged 59 Or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined By Myelomatch; A Myelomatch Clinical Trial
This study is being done to answer the following question: Can we shrink the amount of AML or get rid of it in your bone marrow and body by treating you with the standard approach of cytarabine + daunorubicin (7+3) or one of the following experimental groups: 1) cytarabine and daunorubicin with venetoclax 2) azacitidine and venetoclax, 3) daunorubicin and cytarabine liposome, or 4) daunorubicin and cytarabine liposome with venetoclax?Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Study will last 5 years. After study treatment, doctor will continue to follow condition for 5 years and watch for side effects. The follow-up care may be in-person clinic visits or phone calls. They will check subject every month for 1 year after they join the study. After that, they will check subject every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth and fifth years.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants must have high-risk (adverse) AML per ELN 2017 criteria.
Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per WHO criteria
Participants with favorable or intermediate risk disease are excluded.
Participants with FLT3 mutations (ITD or TKD) are excluded.
Participants with t(9;22) translocation are excluded.