Uterine serous carcinoma (USC) accounts for 40% of endometrial cancer-related deaths. The standard of care for stages III and IV USC yields a 20%–30% survival at 2 years and a 10%–20% survival at 3–5 years. Recent advances in the second-line treatment of advanced or recurrent USC are rapidly evolving. Targeted therapeutic approaches with the use of lenvatinib plus pembrolizumab, as well as the use of trastuzumab deruxtecan, offer new hope for successful second-line therapies for patients. However, further investigation into novel targeted therapeutic approaches is warranted, given the high burden of disease associated with this aggressive histological subtype. USC shares clinical and genomic similarities with epithelial ovarian cancer, suggesting a correlation with ‘BRCAness’. Niraparib, a potent PARP1 and PARP2 inhibitor, was shown to have a positive impact on platinum-sensitive recurrent ovarian cancer, regardless of the presence or absence of BRCA status. Our hypothesis is that patients with stage III, stage IV and platinum-sensitive recurrent USC receiving niraparib maintenance in addition to standard therapy for USC may have an improved progression-free survival.

Participating sites include the primary site, Northwell Health Zucker Cancer Centre, and secondary site, Rutgers Cancer Institute of NJ. Females over the age of 18 with stage III, stage IV or platinum-sensitive recurrent USC will be recruited and enrolled based on inclusion/exclusion criteria. 24 subjects will be enrolled during phase 1 and 21 subjects will be enrolled during phase 2, over a total of 3 years. Patients will receive an individualised dose of niraparib daily every 28 days per cycle for 1 year or until progression of disease. Follow-up of disease status will continue for 5 years poststudy treatment. This phase II clinical trial will employ a Simon two-stage minimax design to test the null hypothesis that the 1 year response rate is

Ethical approval was granted by Northwell Health Cancer Institute institutional review board (reference number: 19–0380) and PRMS. Alongside journal publications, results will be available publicly on completion of the study as approved by the sponsor investigator.

NCTN04080284

Increasing Plasmodium resistance levels to sulfadoxine–pyrimethamine (SP) threaten the effectiveness of intermittent preventive treatment in pregnancy (IPTp) and have prompted the evaluation of alternative strategies. Azithromycin (AZ) could have add-on effects on malaria and treat sexually transmitted infections (STIs), both conditions described as major causes of adverse pregnancy outcomes (APO). Inconsistent findings on the utility of AZ for the prevention of APO were reported; however, thus far, no comprehensive meta-analytic synthesis of data has been published. This review aims to investigate the effects of SP+AZ administered in women as IPTp on the risk of low birth weight in malaria-endemic areas.

Eligible studies will be identified through a pre-established search strategy in several electronic databases (Medline, Cochrane Library, Web of Science, EMBASE, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov and AJOL) and will comprise peer-reviewed papers reporting original data on the effects of SP+AZ on the risk of APO. Only randomised controlled trials published until 30 September 2024 in English or French will be included. IPTp with SP+AZ regimens (intervention) will be compared with IPTp with SP alone or with a placebo (control). As primary outcomes, data on the frequency of low birth weight will be collected. Secondary outcomes include the rates of stillbirth, preterm birth, miscarriage and neonatal death. Data will be extracted independently by two reviewers using a predefined extraction form. If the data quality allows for quantitative synthesis, a fixed-effects meta-analysis will be conducted if there is low inter-study heterogeneity. Otherwise, the random-effects meta-analysis will be conducted to take into account uncertainty in pooled estimates that could be due to inter-study heterogeneity. The review protocol was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) guidelines.

Ethical clearance is not needed as the data will be from already published studies in which informed consent and ethical approval were obtained by primary investigators. Our dissemination plan includes the publication in a peer-reviewed journal as well as conference presentations.

CRD42020149592.