Nowra

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the efficacy, safety, and tolerability of adding ponsegromab to systemic chemotherapy compared to chemotherapy plus placebo for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who have cachexia, a condition causing significant weight loss and fatigue. This Phase 2b3 randomized, double-blind, multinational study focuses on first-line treatment for this advanced cancer and associated cachexia. Participants will receive standard first-line chemotherapy regimens, either nab-paclitaxel plus gemcitabine or FOLFIRINOX, combined with either ponsegromab at one of two doses or a matching placebo. Study intervention is given subcutaneously every four weeks starting on the same day as the chemotherapy cycle and prior to chemotherapy administration. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants will either continue or switch to that dose while remaining blinded. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind phase. During the study, participants will have tumor assessments approximately every 6 to 8 weeks by independent radiologists. Researchers will measure changes in body weight, anorexia symptoms, physical activity, muscle and fat tissue quality, overall survival, and treatment safety through laboratory tests, adverse event monitoring, and patient questionnaires. The study duration extends through Phase 3 with ongoing monitoring until key survival events occur, with an additional optional sub-study assessing caregiver quality of life.

Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.

Researchers are evaluating treatments for people with classical Hodgkin lymphoma that has returned or did not respond to previous therapy. This phase II study compares the effects of two newer drugs, pembrolizumab and brentuximab vedotin, against the current standard salvage treatment combining gemcitabine, dexamethasone, and cisplatin GDP. The aim is to find out if the new drug combination is better or worse at shrinking or eliminating this type of lymphoma. Participants will receive either the standard GDP chemotherapy or the combination of pembrolizumab and brentuximab vedotin. The GDP treatment involves specific doses of gemcitabine and cisplatin given intravenously, plus dexamethasone tablets over several days. The experimental arm receives pembrolizumab and brentuximab vedotin intravenously every 21 days. After these treatments, participants may undergo high dose chemotherapy followed by an autologous stem cell transplant. Treatment starts within two working days of enrollment. During the study, participants will have scans and clinical evaluations to measure how well their lymphoma responds, including complete response rates assessed by PET scans. Researchers will monitor progression-free survival, event-free survival, overall survival, and the success of stem cell collection and transplantation over about 52 months. Participants will also complete quality of life and toxicity questionnaires, and side effects will be recorded. Safety monitoring includes lab tests and assessments throughout treatment and follow-up periods.