Ruskin

Researchers are evaluating how a new medicine called PF-08052667 works alone or combined with Bacillus Calmette Guerin (BCG) and/or sasanlimab in adults with a type of bladder cancer that has not spread into the muscle layer but is likely to return or grow. The study includes people whose cancer has returned or not improved after standard treatments like BCG, as well as those who cannot receive or have no access to standard treatments. This is a Phase 1 study focusing on safety, tolerability, and antitumor effects of these treatments. The study has three parts: Part 1 tests PF-08052667 alone at increasing doses for participants whose disease worsened after standard treatment. Part 2 tests PF-08052667 combined with BCG and/or sasanlimab given at a fixed dose for similar participants. Part 3 further tests PF-08052667 alone or combined with BCG and/or sasanlimab at doses determined from earlier parts, including participants who never received standard treatment. PF-08052667 and BCG are given directly into the bladder through an intravesical infusion, while sasanlimab is given as a subcutaneous injection under the skin. PF-02921367 is used as a 10-minute bladder pre-wash before PF-08052667. Participants will receive study treatments until they decide to stop, are asked to leave, or for up to about two years. Follow-up continues after treatment until loss to follow-up, death, or study end. Researchers will monitor dose-limiting toxicities, adverse events, lab abnormalities, and survival outcomes including recurrence-free and event-free survival. Safety and effectiveness will be assessed throughout treatment and follow-up periods lasting up to approximately two years.

Researchers are evaluating a phase II trial to test the effect of combining pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to see if this combination can prevent the need for surgery to remove the bladder. Standard care involves chemotherapy before surgery to shrink or eliminate the tumor. Pembrolizumab may help the immune system attack the cancer, while radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Participants receive photon beam radiation therapy once daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given through an intravenous infusion on the first day of each 21-day cycle, continuing for up to 18 cycles or about one year, unless the disease progresses or side effects become unacceptable. Patients also undergo transurethral resection of bladder tumor (TURBT) before starting treatment. Imaging tests like CT, MRI, or PET scans, along with cystoscopy and sample collections of urine and blood, are performed throughout the study. During the study, researchers monitor participants’ health with scans, biopsies, and questionnaires about symptoms related to gastrointestinal, urinary, and sexual function. They measure bladder intact event-free survival within three years, local recurrence, metastasis-free survival, overall survival, and the rate of needing surgery to remove the bladder. After treatment, patients are followed every 26 weeks for two years and then annually up to five years. The study also collects samples for future research and tracks treatment side effects carefully.

PRIMARY OBJECTIVE: I. To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm. SECONDARY OBJECTIVES: I. To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined biochemical leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed. II. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo. III. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30-(C30), in participants randomized to receive preoperative lanreotide versus placebo. ADDITIONAL OBJECTIVES: I. To compare change from baseline in pancreatic cancer-specific quality of life and overall health-related quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ- Pancreatic Cancer 26 (PAN26) and European Quality of Life Five Dimension Five Level (EQ-5D-5L), in participants randomized to receive preoperative lanreotide versus placebo. II. To compare the proportions of participants with common postoperative sequelae associated with POPF, including ISGPS delayed gastric emptying and ISGPS post pancreatectomy hemorrhage (grades B/C) occurring within 60 days after surgery, in participants randomized to receive preoperative lanreotide versus placebo. III. To compare time from surgery to initiation of adjuvant chemotherapy among participants with pancreatic ductal adenocarcinoma and planned adjuvant chemotherapy randomized to receive preoperative lanreotide versus placebo. BANKING OBJECTIVE: I. To bank blood, pancreas fluid, and tissue specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive lanreotide subcutaneously (SC) over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3. ARM II: Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3. After completion of study treatment, patients are followed up at 4, 8 and 12 months after surgery.

Researchers are evaluating the effectiveness of a simplified Behavioral Activation program called "Do More, Feel Better" (DMFB), delivered by trained lay volunteers, compared to Behavioral Activation delivered by master's level clinicians. The study focuses on older adults aged 60 and above who attend senior centers and have depression as identified by specific depression rating scales. The goal is to see if the volunteer-delivered intervention can improve activity levels and reduce depression symptoms as effectively as clinician-delivered care, while also exploring treatment satisfaction, overall functioning, and factors affecting intervention fidelity and sustainability. Participants will be randomly assigned to receive Behavioral Activation either from trained volunteers or from master's level clinicians. Both interventions aim to guide clients in reengaging with pleasant and rewarding daily activities to reduce depressive symptoms. The study will be conducted at 18 senior centers across Seattle, New York City, and Tampa. Volunteer and clinician participants must meet educational and language criteria and provide consent for study procedures including session recordings for supervision. During the study, participants will be assessed at multiple time points up to 36 weeks after treatment begins. Researchers will measure changes in depression using the Hamilton Rating Scale for Depression (HAM-D) and changes in activity levels using the Behavioral Activation Scale (BADS). Additional evaluations include cognitive screening, treatment adherence, and client satisfaction. The study will monitor safety and examine long-term outcomes, delivery costs, and factors that affect the quality and sustainability of the interventions.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating telitacicept, a recombinant fusion protein targeting B-cell-mediated immune pathways, in adults with active primary Sjogren's disease. This Phase 3 study aims to assess the efficacy and safety of telitacicept by measuring changes in disease activity using the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) at 48 weeks. Sjogren's disease involves increased B-cell activity and autoantibody production, which telitacicept is designed to modulate by blocking certain cytokines. Participants will receive either telitacicept or a placebo through subcutaneous injections. The study is randomized, double-blind, and placebo-controlled to compare the effects of telitacicept versus placebo in adult patients aged 18 to 75 years with active disease. The treatment period lasts up to 48 weeks, with evaluations focused on changes in disease activity. During the study, participants will undergo assessments including disease activity scoring and antibody status checks. Researchers will monitor safety and efficacy throughout the 48-week treatment period. The main outcome is the change in ESSDAI score from baseline to Week 48, reflecting the impact of telitacicept on Sjogren's disease symptoms and activity.

Researchers are evaluating the effectiveness of radiation therapy combined with chemotherapy and immunotherapy in patients with high-risk stage III-IV squamous cell carcinoma of the head and neck that is HPV-negative. The study aims to compare the usual treatment of radiation therapy with cisplatin chemotherapy against two experimental approaches: radiation with docetaxel and cetuximab chemotherapy, and the usual treatment plus the immunotherapy drug atezolizumab. This phase II/III trial focuses on improving disease-free and overall survival in this patient population. Participants are randomly assigned to one of three treatment groups. One group receives intensity-modulated radiation therapy (IMRT) with weekly cisplatin for 6 weeks. Another group receives IMRT with weekly docetaxel and cetuximab. The third group receives IMRT with weekly cisplatin plus atezolizumab administered intravenously every 3 weeks starting one week before radiation, for up to eight doses. Treatments are given in the absence of disease progression or unacceptable side effects. Throughout the study, patients undergo blood sample collection and may have CT scans, MRI, and biopsies as needed. Follow-up visits occur at 1 and 3 months post-treatment, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. Researchers measure disease-free survival up to 7 years, overall survival up to 7 years, symptom burden, quality of life, and treatment-related toxicities. Blood and tissue specimens are collected for future research.

Researchers are evaluating two radiation therapy approaches for men with high-risk prostate cancer in this phase III trial. The study compares stereotactic body radiation therapy (SBRT), which delivers five higher-dose treatments over two weeks, to the usual radiation therapy that involves 20 to 45 treatments over 4 to 9 weeks. This trial aims to see if the shorter SBRT treatment can prevent cancer from returning as effectively as the longer conventional treatment while monitoring survival without metastasis. Participants are randomly assigned to one of two groups. One group receives SBRT with five treatments over two weeks, while the other undergoes external beam radiation therapy (EBRT) with 20 to 45 treatments over 4 to 9 weeks. Both groups have imaging scans such as bone scans, CT, MRI, or PET/CT during screening and study follow-up. Blood and urine samples may be collected optionally. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants have regular follow-ups every six months for five years. Researchers assess outcomes including metastasis-free survival, toxicity reported by physicians, patient-reported urinary and bowel function, fatigue, failure-free survival, overall survival, sexual function, quality of life, and treatment burden. Various questionnaires and imaging tests support these evaluations, helping to monitor safety and effectiveness over time.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the addition of BMX-001, a drug that neutralizes harmful substances and reduces tissue damage, to the usual symptom management for patients receiving chemoradiation for head and neck cancer. This phase II trial aims to compare the incidence and duration of severe oral mucositis, a painful inflammation and sores in the mouth, between patients treated with BMX-001 and those receiving a placebo. The study also assesses other side effects like dry mouth and skin reactions, overall survival, progression-free survival, pain reduction, and collects blood samples for future research. Participants are randomly assigned to one of two groups. Both groups receive standard cisplatin chemotherapy either weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. One group receives BMX-001 injections under the skin starting before radiation and cisplatin, continuing twice weekly for eight weeks, while the other group receives placebo injections on the same schedule. Patients may have CT or MRI scans during the study and can optionally provide blood, serum, and plasma samples. During the study, patients are monitored from the start of radiation through four weeks after treatment to track severe oral mucositis and other side effects. Additional assessments occur at 6, 8, and 12 weeks post-treatment. Follow-up visits continue at 1, 2, 3, 6, 12, and 24 months to observe long-term outcomes. Researchers use questionnaires, clinical evaluations, and lab tests to measure symptoms, toxicity, and treatment effects throughout the study.