Search Results Within Category "Cancer"
A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate The Safety a Efficacy of Cretostimogene Grenadenorepvec In Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this Phase 2 clinical trial is to study treating patients with non-muscle invasive bladder cancer (NMIBC) with an investigational drug, Cretostimogene and DDM. Participants will be assigned to either Cohort A or Cohort B depending on whether they have previously been treated with BCG (Bacillus Calmette-Guerin) for NMIBC.
Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. For the first 2 years after treatment initiation, participants will be assessed for disease status every 3 months by urine cytology and cystoscopy, with directed TURBT/biopsy (if indicated). CT urogram or MRU will be performed every 6 months. Thereafter, efficacy assessments will be performed at 6-month intervals for up to an additional 2 years
PSCI 23-130 RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
This trial is looking at the progression free survival and overall survival in patients treated with docetaxel alone and those treated with docetaxel and RAS G12X-C
This study has 4 periods: 1. Pre-screening period (to provide your tumor genetic information) 2. Screening period (before you begin the study to see if you qualify for the study). This is when you will have all the testing done to make sure it is safe for you to join the study. it may require several trips to the hospital. 3. Study Treatment period (when you will receive the study treatment; this occurs in 21-day cycles). this is when you will be taking the study medication. For the first cycle of treatment you will need to come to the clinic about 3 times to make sure you are ok while taking the study drug. From cycle 2 onward you will need to come to the clinic twice. 4. Follow-up period (to check on you after your study treatment is finished) and then we will check to see how you are doing every three months. It is important that you come to all of your visits.
Histologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Evidence of progressive disease (PD)
Chemotherapy and Antibody Therapy; ≥3 weeks of randomization
Symptomatic congestive heart failure
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) with Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies
This study is testing whether a lower dose of a medicine called cyclophosphamide (25 mg per kg), given after an allogeneic stem cell transplant, can reduce serious side effects and improve outcomes. We are enrolling people who are receiving a reduced-intensity or non-myeloablative (less intensive) stem cell transplant. We will follow participants for one year after their transplant to see if they stay free from severe graft-versus-host disease (GVHD), cancer relapse, or death. We will also look at overall survival, rates of GVHD, infections, donor cell recovery, and other side effects.
You must attend all scheduled study visits, tell the study doctor about all medications you are taking (including over-the-counter medicines), and let the study team know how you are feeling. Before joining the study, you will have routine health checks. These include breathing tests (called pulmonary function tests, or PFTs) to see how well your lungs work, and a heart scan (MUGA scan or echocardiogram) to see how well your heart is pumping. As part of this study, you will be given a low dose of cyclophosphamide (25 mg/kg) on day +3 and +4 after your stem cell transplant. You will be carefully monitored for any side effects, and the study team will evaluate your risk for graft-versus-host disease (GVHD) and disease relapse.
Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.
Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with <5% vs 5-10% blasts in this disease).
Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.
Active central nervous system (CNS) involvement by malignant cells.
Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
PSCI# 25-118 A012303: ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy with HER2 Blockade
This study is to see if patients with clinical stage I-III HER2+ breast cancer who achieve a pCR after neoadjuvant chemotherapy with HER2 blockade and receive a total of 6 months of HER2 blockade in the combined neoadjuvant + adjuvant (neo/adjuvant) setting will NOT have inferior (RFS) compared to patients who receive the standard total of 1 year of HER2 blockade.
Participants will get the HER2-targeted medication trastuzumab (with or without pertuzumab) for up to 51 weeks (approximately 12 months), or they will get the HER2-targeted medication trastuzumab (with or without pertuzumab) for up to 27 weeks (approximately 6 months). After participant finishes study treatment, your doctor will continue to follow your condition every 6 months for 5 years and watch for side effects or cancer coming back. Participants will see your doctor for 5 years after treatment. After that, every year for a total of 10 years after being enrolled on the study.
has not been naturally postmenopausal for at least 12 consecutive months
Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1
Age ≥ 18 years
ECOG Performance Status 0-2
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer
History of grade 3 or 4 toxicity related to trastuzumab
PSCI# 24-172 TITLE PAGE A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
This study will see if participants who have the addition of saruparib to their treatment will have a longer time period before/if their cancer spreads.
Before participating in the trial, p[otential; participants will need to sign a consent form to have their tumor tested for the BRCA mutation. If the participants have this mutation in their tumor, they will be invited to participate in this trial. While you are receiving treatment you will need to come to the clinic on certain days for treatment, getting safety assessments, collection of blood samples and to see how you are feeling. You will come to the clinic every four weeks. The treatment will last for 24 months
Participants with newly diagnosed high-risk and very high-risk (localised/locally advanced) prostate cancer
Confirmed BRCA1 or BRCA2 mutation
Participants with any known predisposition to bleeding
Refractory nausea and vomiting
PSCI # 24-026 EA8231 A Phase III Randomized Trial of Pembrolizumab in Combination with Sacituzumab Govitecan vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer
This study is comparing Pembrolizumab in combination with Sacituzumab Govitecan vs. standard treatment for individuals who have drug resistant advanced urolethial cancer
Participants will need to come to the clinic to meet with the study team and to sign a consent form. Once it has been determined that it is safe for you to participate, you will come into the clinic for treatment every 21 days, or depending upon the treatment arm you are assigned. You will continue to come into the clinic for treatment until the medication stops working, you no longer want to participate in the study or the document feels it is not safe for you to continue. You will be followed for up to five years to see how you are doing.
Patient must have ECOG Performance Status 0-2.
Patient must have locally advanced (unresectable or not amenable to curative intent therapy) or metastatic urothelial cancer.
Patient must have histologically proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥ 1% urothelial histology).
Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily).
Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy
This is a Phase 2b clinical research study, which is investigating the use of 5-Aminolevulinic Acid (5-ALA) combined with a Low-Intensity Diffuse Ultrasound (LIDU) system for Sonodynamic Therapy (SDT) in patients with newly diagnosed glioblastoma. LIDU is the name of the investigational SDT device developed by Alpheus Medical. SDT includes the combination of a sonosensitizing drug, also known as a sonosensitizer, that will only be absorbed by tumor cells, and ultrasound to activate the sonosensitizer and cause damage to the tumor cells. The SDT tested in this study includes the oral drug 5-Aminolevulinic Acid (5-ALA) as an investigational sonosensitizer. This investigational treatment is being tested as a potential treatment for your cancer, SDT has been shown in previous cell and animal studies to potentially have an anti-cancer effect.
In this research study there will be two treatment groups. One treatment group will receive standard of care maintenance temozolomide with 5-ALA + SDT, you will have a 50% of receiving this treatment group. The other treatment group wll receive standard of care maintenance temozolomide with placebo, an oral solution that will look like and taste like 5-ALA but will have no active ingredients in it, and sham SDT, a program will be run on the SDT device that will look and sound the same, but will not deliver ultrasound, you will have a 50% chance of receiving this treatment group. If you are eligible for the study, and agree to participate you will be randomized, like the flip of a coin, to one of the two treatment groups, neither you nor your doctors will know which treatment group you have been assigned.
≥ 18 and ≤ 80 years of age at time of signing informed consent
Newly diagnosed Histologically proven glioblastoma
Completion of chemoradiation consisting of radiotherapy
Adequate bone marrow and organ function,
Bihemispheric disease or tumors that involve the bilateral corpus callosum,
Multi-centric disease (enhancing or non-enhancing) or multi-focal disease
Leptomeningeal disease
A diagnosis of gliosarcoma by histopathology
PSCI 24-072 A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy MajesTEC-7
This trial is designed for patients who are newly diagnosed with multiple myeloma (MM) but who do not want or cannot have an autologous stem cell transplant. Teclistamab and talquetamab have been used alone along with other drugs in the treatment of MM. this study hopes to add either drug to a standard treatment for MM at time of diagnosis to see how effective it is in keeping the MM quiet conpared to standard treatment alone.
Participants must be willing to come to all clinic study visits. The first cycle of treatment the participant will be hospitalized to make sure they do not have any side effects. You will be treated every four weeks as an outpatient until the treatment no longer works. You should tell your study team all side effects you feel and all medication you are taking.
$54.00 per completed visit. A caregiver may receive compensation of the same amount.
Have a diagnosis of multiple myeloma
Be newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT
Received any prior therapy for multiple myeloma
Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
PSCI 24-147 A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF TRASTUZUMAB DERUXTECAN (ENHERTU®) PLUS CHEMOTHERAPY PLUS OR MINUS PEMBROLIZUMAB VERSUS CHEMOTHERAPY PLUS TRASTUZUMAB PLUS OR MINUS PEMBROLIZUMAB AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) CANCER (DESTINY-GASTRIC05)
To see if the combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus SoC chemotherapy plus trastuzumab plus pembrolizumab is better in treating gastric or gastroesophageal junction cancer
Participants will need to come to the clinic twice before they are able to start study treatment. The first time is to sign a consent form allowing their tumor tissue that has been stored to be spent for testing. This test will look to see if the tissue has changes in it to see if the medication will work. If the tissue has the receptive changes a second consent form will be signed to participate in the study. You will need to have tests done to make sure it is safe for you to participate in the study. If the tests results determine that is it safe, you will begin treatment. The first month of treatment you will need to come to the clinic every week for blood tests and to see how you are feeling. After that you will need to come to the clinic once a month for treatment and blood tests. You will also have scans done at certain time in the study. Those scans will tell the doctor if the study treatment is working to make your cancer go away. You will stay on this treatment until it stops working. After that, you will come back to the clinic for two more visits to see how you are feeling.
Is willing and able to comply with scheduled visits, trial intervention plan, laboratory tests, other trial procedures, and trial restrictions.
Medical history of myocardial infarction within 6 months
PSCI 25-083 Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia
To evaluate the long-term safety of AAV2-hAQP1 in participants with radiation-induced late xerostomia
Participants who were on the parent trial and did not receive actual drug will be invited to be treated and then rolled over into long term follow up. For those who were treated with actual drug will roll over into a long term follow up. Long term follow up participants will be followed up monthly for 5 years.
$60 per visit
ALTE2131: Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Arm A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. Arm B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
A blood sample taken for the study; about 15 mL (one tablespoon of blood) will be drawn at each of these four times: before cancer treatment begins; at the end of cancer treatment;1 year after the end of cancer treatment; 2 years after the end of cancer treatment.
Patient must be a post-menarchal female
Newly diagnosed with first cancer, exclusive of breast cancer.
Planned bilateral oophorectomy
AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC# 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse
This is a drug study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL).
All subjects on study will be treated with the medicine blinatumomab. Some subjects will also receive an additional medicine, nivolumab. Subjects will receive treatment on this study for about 1.5-2.5 months. Treatment is divided into 1-2 cycles. Before the start of therapy, patients will have a bone marrow evaluation for Immunophenotyping and will have their bone marrow tested for MRD on Day 36 of cycle 1 and Day 36 of cycle 2 during treatment.
Patients 18 years or older with first marrow relapse of B-ALL
Lactating females are not eligible unless they agree to not breastfeed their infants.
Gaining insight into parental decision-making for enrollment in early phase and precision medicine clinical trials for children diagnosed with cancer: The BEAT-PED mixed-methods study
This study aims to understand how parents make decisions about enrolling their child in an early phase or precision medicine cancer clinical trial. We will explore parents’ decision-making process, values, goals, and views of risks and benefits, as well as their psychosocial outcomes. Participants will be asked to complete a set of questionnaires, and they may choose to take part in an optional interview to discuss their decision-making in more depth. Please note that parents whose child was offered a upfront standard of care clinical trial at diagnosis (i.e., a phase III trial comparing treatments that are already accepted and evidence-based, rather than novel or experimental agents) are not be eligible to participate.
This study entails completing an anonymous questionnaire asking items related to you and your child’s demographic information, how you are doing on key psychosocial outcomes (e.g., psychological distress, anxiety, depression), your perceived moral obligation, your emotional expressivity and authenticity, your coping style, your level of trust in the provider, and your perceived social support. This survey may take up to 1 hour to complete. At the end of the questionnaire you will be asked if you would be interested in participating in a one-time 30-60 minute conversation to provide a more in depth discussion on these topics. If you are interested, a study team member will reach out to you to provide more information and have you sign a separate consent form for that part of the study.
Be the parent/legal guardian of a child who is/was enrolled or was eligible to enroll in an early phase or precision medicine clinical trial.
Be the parent/legal guardian of a child aged under 20 years old at trial enrollment
Be able to read, speak, and understand English, Spanish, or French
Having a child enrolled in an upfront standard of care clinical trial at diagnosis.
Not meeting the inclusion criteria.
PSCI 25-034 TITLE PAGE A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
This will compare Dato-Dxd against docetaxel in previously treated advanced or metastatic non squamous NSCLC.
the first visit will be to sign a consent form to test for a specific biomarker in your archived tumor. If you have that biomarker you will then sign a consent form to participate in the study, if you wish. You will need to come to the clinic for bloodwork and scans to make sure it is safe for you to participate. If it is determined that it is safe for you to continue, you will come to the clinic every month for treatment of your cancer. These visit may also include seeing the doctor, having blood work and completing questionnaires.
$1200.00 You will only be compensated for completed visits.
Has pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous NSCLC
Participants must have documentation of radiographic disease progression
NSCLC disease that is eligible for definitive local therapy alone
History of another primary malignancy
PSCI# 25-139: NRG-GU012: Randomized Phase II Stereotactic Radiation Therapy (SABR) For Metastatic Unresected Renal Celil Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC).
The patient will either get immune therapy (either 2 immune therapy drugs or immune therapy plus a VEGF targeted therapy), or get immune therapy plus radiation therapy. The radiation treatments will be given on 3 different days over the course of 1-3 weeks. Immune therapy will continue until it is no longer working. After the treatment is stopped, the doctor and study team will monitor the patient every 6 months for 5 years after treatment and then annually for 3 years.
Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>3 factors)
Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma
Patients with measurable disease (node positive or metastatic)
Candidate for standard of care therapy with either IO-IO or IO-VEGF combination regimen
Patients with untreated or unstable brain metastases or cranial epidural disease
Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration
Pregnancy and individuals unwilling to discontinue nursing
PSCI 24-119 A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol/Cannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy
This study will look at the safety and effectiveness of cannabigerol (CBG)/cannabidiol (CBD) in the treatment of chemotherapy induced peripheral neuropathy.
You must attend all scheduled study visits, tell the study doctor about all medications you are taking (including over-the-counter medicines), and let the study team know how you are feeling. Patients must come to clinic visits (about every 4 weeks) for health checks, blood tests and surveys, take the hemp oil (CBG/CBD) twice a day for 12 weeks, complete a drug diary, return unused oil on their next visit, and answer phone calls between visits.
$500.00 if substudy completed
Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks
Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years
Patients from Penn State Health
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy
Patients who have suicidal ideation or uncontrolled depression within the past year
Patients with known sensitivity to any components of CBG/CBD hemp extract
Patients with known sensitivity to coconut oil
History of or active arterial thromboembolic event
Developmental Differences in Physical and Psychosocial Outcomes in Children and AYAs with Cancer and Survivors: The Pediatric Adjustment to Treatment and Healing (PATH) Study
This study examines how physical health and emotional well-being differ across ages in children, adolescents, and young adults with cancer, cancer survivors, and individuals without a history of cancer. The goal of the study is to better understand how experiences such as fatigue, pain, sleep, physical activity, mood, anxiety, and quality of life vary at different ages and at different points in the cancer journey (during treatment versus after treatment), and how factors like treatment intensity and family resources may influence these experiences. Participants will be asked to complete a set of online questionnaires about their physical health, daily functioning, and emotional well-being. No medical procedures or treatments are involved.
Participants will be asked to complete a set of online questionnaires about their physical health, daily functioning, and emotional well-being. No medical procedures or treatments are involved. The questionnaires will take approximately 45 minutes to complete. - For children aged between 2 and 7 years old, we ask that parents report on behalf of their child. - For children/adolescents aged between 8 and 17 years old, we ask that they complete the survey themselves. Parents may also report on behalf of their child if the child is unwilling or unable to complete the survey themselves. - For young adults aged between 18 and 24 years old, we ask that they complete the survey themselves. Parents may not complete the survey on their behalf.
Fluent in English
Having a non-oncologic primary diagnosis if in the children/AYAs with cancer group (the child or young adult’s main medical diagnosis is not a cancer or tumor)
For healthy volunteers, having a chronic medical condition diagnosed by a healthcare professional
PSCI #25-129: NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed By Chemoradiation and Pembrolizumab Vs Chemoradiation and Pembrolizumab Both Followed By Pembrolizumab For High Risk Locally Advanced Cervical Cancer
To determine whether induction IO and chemotherapy prior to CCRT+IO improves progression-free survival (PFS) compared to CCRT+IO alone.
The patient will either get induction therapy, chemoradiation with pembrolizumab, and pembrolizumab maintenance therapy for up to 2 years, or chemoradiation and pembrolizumab followed by pembrolizumab maintenance therapy for up to 2 years. Induction therapy means they will receive chemotherapy with cisplatin and paclitaxel once a week for 6 weeks, plus pembrolizumab every 3 weeks for 2 doses, before starting chemoradiation and pembrolizumab. After the patient finishes treatment, they will check the patient every 3 months for the first 2 years after treatment. After that, they will check every 6 months for 3 years. This means the patient will keep seeing their doctor for 5 years after treatment.
Adequate renal function
Adequate hepatic function
Adequate cardiac function
ECOG Performance Status of ≤ 2
Prior definitive surgical, radiation, or systemic therapy for cervical cancer.
Prior immunotherapy
Prior pelvic radiation therapy for any disease
History of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s)
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to understand if an investigational treatment (pasritamig) added to docetaxel for progressive metastatic hormone resistant prostate cancer will work better than docetaxel alone.
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
Have histologically confirmed adenocarcinoma of the prostate.
Have disease that is metastatic at the time of the screening as determined by the investigator.
PSA level ≥2 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera as defined by RECIST v1.1 and/or in bone scan per PCWG3 while on medical or surgical castration.
Patients with known BRCA 1/2 mutations (germline or somatic) who have not received treatment with a PARP inhibitor, unless not available or contraindicated.
Suspected or known allergies, hypersensitivity, or intolerance to pasritamig excipients or docetaxel excipients
Not recovered from recent surgery.
Solid organ or bone marrow transplantation.
PSCI 25-075: A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
This Study is being done to understand how well INCB123667 works, how safe it is, and how well it is tolerated in people with platinum-resistant ovarian cancer whose tumors have high levels of cyclin E1.
On certain visit days, subject will need to take Study Drug tablets at the Study Site instead of at home. On those days you must fast (no food or drinks) for 8 hours before your visit, so that certain blood tests can be done before you take your Study Drug.
Female participants aged 18 years or older at the time of signing the ICF
Histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Willingness to undergo pretreatment biopsy.
Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine due to it being unavailable.
History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.
Known active CNS metastases and/or carcinomatous meningitis.
Significant concurrent, uncontrolled medical condition.
PSCI # 25-036 A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA
This study is comparing two treatments for the treatment of melanoma.
You will need to come to the clinic twice before start study treatment. The first time is to sign permission to send your tumor to be tested for specific changes. If those changes are in the tumor you will be brought back to the clinic and invited to participate in the study. After testing and scans are done to make sure it is safe for you to take part in the study, you will begin treatment. You will come to the clinic every 3-4 weeks for treatment. You will continue treatment until it no longer works, you no longer wish to receive treatment, or the study doctor feels it is not safe for you to continue.
$60.00 for each completed visit
unresectable stage III and stage IV (metastatic) melanoma
must not have received prior systemic therapy
Uveal, acral or mucosal melanoma.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection
A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease
The purpose of this voluntary research study is to evaluate the effects of pumitamig compared with placebo in combination with chemotherapy.
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
$50.00 per visit
Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
Have confirmed locally recurrent inoperable or metastatic TNBC, or ER-low, HER2-negative breast cancer documented prior to trial screening as part of standard of care.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
Have provided a tissue sample, archival or fresh, during the screening period
Have received prior treatment with a PD(L)-1/VEGF bispecific antibody.
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial,
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
ALTE2321: Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
This study is being done to answer the following question: How can a home-based physical activity program best meet the unique language and cultural preferences of Hispanic or Latino/a AYA survivors of cancer? In order to develop a culturally-tailored physical activity program that works well, we know we must address the unique language and cultural needs of Hispanic or Latino/a AYA survivors of childhood cancer. We are doing this study because we want to find out what ideas work best to encourage Hispanic or Latino/a childhood cancer survivors to stay physically active after receiving cancer treatment.
complete participant contact forms, surveys and questionnaires, social media interaction with participant group, wearing an exercise tracker (FitBit).
($30 per each qualitative interview completed
First diagnosis of malignant neoplasm in first and continuous remission at the time of enrollment.
Self-identify as Hispanic, Latino/Latina/Latinx
Completed all chemotherapy and/or radiation therapy in the last 3–36 months. This includes completion of all oral (e.g., tyrosine kinase inhibitors) and/or maintenance chemotherapy.
Able to read and write Spanish or English.
Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded.
Participants who were enrolled in ALTE2031 (Step by Step) cannot enroll in ALTE2321. Participants who were enrolled in ALTE2321 Stage 1 (cultural tailoring) cannot enroll to participate in Stage 2 (RCT)
MOMENTUM-1: A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II STUDY OF [177LU]LU-DOTATATE IN ADULTS WITH PROGRESSIVE INTRACRANIAL GRADE 1-3 MENINGIOMA
We are doing this study because we want to find out if this study therapy is better or worse than the usual drug therapy for your meningioma. The usual is defined as the standard of care most people get for meningiomas that have come back after treatment.
Your participation in this study will last a maximum of 4 years. If you are randomized to Group 1, your study doctor will discuss the usual drug treatment options with you and you will be followed for up to 24 months. Your total participation could be up to 14 research visits which includes up to 6 months of treatment and 18 months of follow up. If your meningioma progresses within the first 12 months, you may switch to Group 2 and the 24 month follow-up clock restarts. If you are randomized to Group 2, you will receive the study drug once every 4 weeks for up to 4 times (total duration of 3 months). If after 4 doses your meningioma has not grown and you are tolerating the study treatment, you may receive 2 more doses of study drug. Your total participation for Group 2 could be up to 14 research visits which includes up to 6 months of treatment and 18 months of follow up.
Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan
Progression of disease determined by local radiology review
Patients must be willing and able to undergo regular MRI scans of the brain and [68Ga]Ga-DOTATATE PET-CT imaging during the study.
Adequate organ and bone marrow function
Patients with radiation-associated meningiomas.
Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column.
Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.
An active malignancy ≤ 3 years.
PSCI# 26-013 A Randomized Phase II Study of Amivantamab (JNJ-61186372) and hyaluronidase (rHuPH20) versus Cetuximab in Immunocompromised Participants with Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma
To see how well amivantamab works in immunosuppressed patients with cutaneous squamous cell cancer.
Participants will need to come to the clinic every week for the first four weeks of treatment while you are getting the amivantamab. After that you will come in monthly for treatment. You will continue treatment until it stops working, you no longer want to participate in the trial or the doctor\ thinks it is no safe for you to participate. Make sure to tell the study team how you are feeling and any medications that you er taking.
Participants must have CLL, acute leukemia, lymphoma, multiple meyloma, recent organ transplant, autoimmune disease
Participant must be ≥ 18 years old
.PSCI# 25-163 The NEO-RT Trial: A Phase 3 Randomized Trial of Neoadjuvant Chemotherapy, Excision and Observation Versus Chemotherapy For Early Rectal Cancer
This is an international multi-centre, phase 3 randomized non-inferiority trial comparing induction FOLFOX/CAPOX chemotherapy followed by transanal endoscopic surgery (TES) to chemoradiation (chemoRT) followed by transanal endoscopic surgery (TES) in patients with cT1-T3ab*/N0 pMMR rectal adenocarcinoma.
Participants will receive chemotherapy with or without radiation for approximately 12 weeks. Once treatment is completed, they will have tests to see if the cancer is gone. Depending upon the scan results, the participant may have surgery or watch and wait. Total participant ime would be five years.
cN0 stage based on pelvic MRI – including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).
M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.
Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.
Medically fit to undergo radical TME surgery as per treating surgeon’s decision.
Patients with visible pelvic sidewall nodes on MRI.
Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.
Prior treatment for rectal cancer.
Any contra-indications to undergo MRI imaging.
PSCI # 25-077 A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (BLUESTAR-Endometrial01)
This study will compare Puxitatug Samrotecan vs. standard of care in the tretment of advanced endometrial cancer.
Participants will have two screening visits. One to sign a consent for testing of tumor tissue for B7-H4 mutation. If they have this mutation, you will come back to the clinic to sign a second consent to participate in the trial. At that time, you will have scans scheduled and blood work drawn to make sure it is safe for you to participate. After you have started study medication, you will be expected to keep all your study appointments, tell the study team how you are feeling and report on any medications you are taking.
≥ 18 years
Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy
A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma
The study is being done to learn how well tirabrutinib (investigational drug) works against cancer as compared to the combination of rituximab and temozolomide (comparator) in participants with PCNSL. We will also learn more about the safety of tirabrutinib and look at how tirabrutinib may affect the body.
To be in this study: o You must have confirmed PCNSL that has come back after treatment (relapsed) or has not improved with prior treatment (refractory) o You must have received methotrexate previously. You will be required to only take the assigned study drug to treat your cancer while on this study. If you believe that you will want to receive other therapy for your cancer, you should not participate in this study. You must agree to not participate in any other study while participating in this study or take any other therapy for your cancer while participating in this study.
Participants aged ≥18 years on the day of consenting to the study
Relapsed or refractory B-cell PCNSL with at least 1 prior HD-MTX–based therapy for PCNSL
Pathology report confirming the diagnosis of B-cell PCNSL
Life expectancy of at least 3 months
Participants who have contraindications to MRI or use of MRI contrast
Participants with non-B cell PCNSL
Participants with systemic presence of lymphoma
Refractory to temozolomide with or without rituximab containing regimens (eg, methotrexate-temozolomide-rituximab) in the last PCNSL treatment
PSCI 25-150 A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer
This trial will be comparing a new drug against investigator's choice of therapy in the treatment of endometrial cancer that is HER 2 in addition to using a new assay to measure Her2
After the determination is made that it is safe for the patient to participate, the consent form will be signed, and the patient will have scans and blood work taken. The subject is expected to come to all study visits, report to the study team how they feel and let them know about any changes in medication. The study treatments will be given once a week for 21 or 28 days until the medication no longer works, you no longer want to take the medications, or the study doctor feels it is not safe for you to continue. After you complete treatment, you will be seen by the study team monthly for three months then followed for survival for 5 years.
$125 for every completed visit.
Have histologically confirmed recurrent endometrial cancer that:
Have measurable disease
Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 wks prior to the first dose of trial treatment.
Have uncontrolled or significant cardiovascular disease,
Uncontrolled hypertension
Phase 1 of GAME-ONc (Gaming for Adolescent Mental Health and Empowerment in Oncology): A Qualitative Focus Group Study to Inform the Development of a Video Game Intervention for Adolescents and Young Adults with Cancer
The GAME-ONc Study aims to explore how video games can support teens and young adults going through cancer treatment. We will talk with adolescents and young adults with cancer, their parents, and healthcare providers to better understand what emotional, social, and practical challenges young people face during treatment, and how a video game intervention might help. The study will also ask participants what kinds of game features they’d like to see, such as whether the game should be single-player or involve someone else, what topics it should include (like coping strategies, health behaviors, or ways to connect with others), and how to make it easy and enjoyable to use. Ultimately, the feedback from this project will guide the design of a video game prototype tailored for teenagers and young adults with cancer, setting the stage for future testing and development.
Participants will complete a brief demographic and gameplay preferences questionnaire and then take part in a one-time focus group session (approximately 1-1.5 hours) conducted via Microsoft Teams or in person. During the focus group, participants will discuss psychosocial needs of adolescents and young adults with cancer and share their opinions on desired features, content, and usability of a proposed video game intervention. The session will be audio and video recorded for research purposes.
100
Any type of cancer diagnosis
Parents/legal guardians of eligible AYA patients are also invited to participate.
Pediatric oncology healthcare providers who work with in-treatment AYAs
Fluency in English
Be an AYA or the parent of an AYA who has a non-oncologic primary diagnosis (i.e., the child or AYA’s main medical diagnosis is not a cancer or tumor, their primary condition is something other than an oncologic disease.