Allegheny County

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

This research aims to evaluate the effects of vedolizumab intravenous IV combined with either adalimumab or ustekinumab in adults with moderate to severe Crohns Disease who have not responded adequately or have lost response to certain prior treatments. The study investigates the safety and efficacy of these dual targeted therapies, followed by vedolizumab alone. Approximately 100 participants will be enrolled, with the overall study duration lasting about 76 weeks. Participants in Part A will receive dual targeted therapy one group will get vedolizumab IV plus adalimumab subcutaneous injections, and another group will receive vedolizumab IV combined with ustekinumab through initial IV infusion followed by subcutaneous doses. Those who respond to Part A treatment will continue in Part B, receiving vedolizumab IV monotherapy every 8 weeks from Week 30 to Week 46. After treatment, participants will have a safety follow-up period extending to Week 72. During the study, participants will undergo multiple assessments including endoscopic evaluations using the Simple Endoscopic Score for Crohns Disease SES-CD at Weeks 26 and 52. Clinical remission and symptom remission will be tracked at various time points using the Crohns Disease Activity Index CDAI and patient-reported outcome measures. Safety monitoring and follow-up continue for at least 26 weeks after the last treatment dose to evaluate treatment effects and adverse events throughout the study period.

Researchers are evaluating the effect of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults aged 18 to 65 with moderate to severe ulcerative colitis who have not responded adequately to certain prior treatments. This phase 4 study focuses on clinical remission rates and treatment response in this population, aiming to understand the benefits of dual targeted therapy followed by vedolizumab alone. All participants first receive vedolizumab 300 mg via IV infusion at Weeks 0, 2, and 6 plus tofacitinib 10 mg tablets twice daily from Week 0 to Week 8. Those who respond clinically at Week 8 continue with vedolizumab 300 mg IV every 8 weeks alone through Week 46. The study lasts up to 76 weeks including treatment and follow-up. Participants undergo clinical assessments including Mayo score evaluations at multiple timepoints to measure remission and response. Safety is monitored through adverse event tracking and laboratory tests up to 26 weeks after the last vedolizumab dose. Patient questionnaires on quality of life and fatigue are also collected, with total participation extending over a year.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

This clinical trial investigates treatment options for men with unfavourable risk localized prostate cancer. Researchers are comparing a newer radiation method called Stereotactic Body Radiation Therapy SBRT, which uses higher doses over fewer sessions with special equipment, against the standard external beam radiation combined with a brachytherapy boost. The study aims to find out if SBRT is as effective as the standard approach in controlling prostate cancer progression. Participants will receive either the standard treatment involving external beam radiation to the pelvis and prostate plus a brachytherapy boost, combined with hormone therapy, or the experimental SBRT treatment delivering higher radiation doses in fewer sessions. Adjuvant androgen deprivation therapy ADT will be given according to risk level, lasting 6 months for intermediate risk and 24 months for high or very high risk. Treatments are assigned randomly to compare outcomes between groups. Throughout the study, participants will be monitored for cancer progression, side effects, and quality of life using questionnaires and medical assessments for up to 8.6 years. Researchers will track progression-free survival, PSA response, metastasis-free survival, and overall survival, as well as participant-reported tolerability and economic outcomes. Safety will be assessed continuously to understand how well participants tolerate the treatments over time.

This research evaluates the effects of online leadership and autism accommodation training for pairs consisting of an autistic adult aged 18 to 36 and a non-autistic learning partner, such as a parent or guardian. The study aims to improve emotional literacy, healthy relationships, and autism accommodation skills, assessing the trainings impact on both members of the pair. Participants are generally healthy and have a community diagnosis of autism spectrum disorder ASD confirmed by a licensed clinician. The autistic adults receive Kairons leadership training focused on emotional intelligence and healthy relationships, while their paired learning partners receive autism accommodation training. The intervention is delivered entirely online, requiring participants to use their own computers, software, and internet connection. Training involves daily sessions lasting 15 to 30 minutes for five days per week over a month, with one day off during the third week, plus two sets of online questionnaires lasting 60 to 90 minutes each. Participants complete assessments before and after the training to evaluate its effectiveness, usability, and motivation. Both autistic adults and their learning partners evaluate not only their own training but also the training received by their partner. The primary outcome measure is training effectiveness, assessed in sessions lasting 55 to 85 minutes. Participants must be able to provide consent in English and comply with study procedures. The total duration of participation aligns with the training and assessment timeline over approximately one month.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.