Epithelial Ovarian Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.

This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).

The study aims to provide a comprehensive overview of HRD testing practices for epithelial ovarian cancer in Italy. In 2024, approximately 5,423 new cancer diagnoses were estimated in Italy. The centers participating in this study collectively manage about 40-50% of all ovarian cancer cases diagnosed annually in the country, offering a robust and representative snapshot of national clinical practice and treatment patterns. The promoting center has also been recognized as a referral center for ovarian cancer treatment by the European Society of Gynecologic Oncology, based on the number of patients treated and the quality of treatment parameters. HRD testing is recommended at diagnosis for patients with HGOC, in line with NCCN (ref) and ESMO guidelines (ref), so that treatment decisions, particularly the use of PARP inhibitors, can be informed early in the clinical pathway. Several commercial assays are available, each adopting different approaches to evaluate genomic instability. Although HRD testing is central to guiding treatment decisions in HGOC, its implementation remains challenging and subject to laboratory variability in methodology and interpretation. Real-world evidence on how frequently HRD results influence clinical management and how these results correlate with other patient or disease characteristics is still limited. This study aims to collect detailed information on patients tested in referral laboratories in Italy and the impact of HRD status on therapeutic choices. A retrospective analysis will be conducted on a multicenter cohort of HGOC patients who consecutively underwent HRD testing. Since the participating centers treat a substantial proportion of FIGO 2014 stage III-IV HGOC cases nationwide, the study provides an indirect estimate of HRD testing uptake in clinical practice. Study design: Multicenter (n=7), observational, retrospective, non-profit study co-funded by Astrazeneca Spa Data Source(s): Data will be collected in all participating centers through a GDPR compliant electronic form. Study Population: 1125 advanced (FIGO stage 2014 III-IV) HGOC patients addressed to HRD testing at multiple centers. Outcome(s): Main outcomes include: 1. Prevalence of HRD-positive tumors; 2. Association between HRD status and key baseline clinical characteristics; 3. Treatment choices following HRD determination; Secondary endpoints include: 1. Turn-around-time (TAT) for HRD report; 2. Assay feasibility and reportability; 3. Correlation between HRD score and continuous clinical measures; 4. Time-to-event exploratory prognostic outcomes by HRD status (exploratory). Sample Size Estimations: Based on an expected HRD positivity rate of 40% among EOC patients, an effective sample size of approximately 1,046 patients (accounting for a 7% drop-out from an initial cohort of 1,125 patients) will allow us to estimate the prevalence with a 95% confidence interval of ±3%. Additionally, this sample size provides over 80% power to detect a 10% difference in HRD positivity rates between subgroups (e.g. different test types) at a significance level of 0.05. Therefore, the proposed sample size is sufficient to achieve the study's objectives and will provide statistically robust and clinically meaningful insights into HRD testing practices in Italy.

This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \[68Ga\]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.

The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after firstline platinum-based chemotherapy plus bevacizumab.

Epithelial ovarian cancer (EOC) is the fifth leading cause of cancer-related death in women, with approximately 320,000 new cases and 200,000 deaths annually worldwide, and its incidence is rising. Current treatment mainly relies on surgery, chemotherapy, and radiotherapy, but EOC frequently develops platinum resistance and recurrence. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), was approved by the FDA in 2024 for FRα-positive, platinum-resistant EOC. However, it carries significant toxicities (ocular, interstitial lung disease, peripheral neuropathy) and a modest objective response rate of 33%, with rapid acquired resistance, underscoring the need for patient selection and response prediction via targeted imaging. FRα, a GPI-anchored cell-surface glycoprotein encoded by FOLR1, is minimally expressed in normal adult tissues but overexpressed in various epithelial tumors, including ovarian cancer. Its overexpression promotes invasion, metastasis, and potentially drug resistance, making it a promising theranostic target. While ¹⁸F-FDG PET/CT is widely used, it has limitations in detecting low-activity or small lesions and shows suboptimal sensitivity/specificity for nodal metastases. Radiolabeled folate probes (e.g., ⁹⁹ᵐTc-EC20) have demonstrated excellent FRα-targeting and clinical utility in selecting patients for FRα-directed therapies. Our team has developed ⁸⁹Zr-DFO-Mirvetuximab by conjugating the anti-FRα monoclonal antibody with the chelator p-isothiocyanatobenzyl-desferrioxamine B and radiolabeling with ⁸⁹Zr. Preclinically, this probe exhibited favorable stability, safety, and specific targeting of FRα-high tumors in xenograft models. Building on these results, we plan a clinical study enrolling 20 patients with newly diagnosed stage IV or first-recurrent EOC, who will undergo both ⁸⁹Zr-DFO-Mirvetuximab PET/CT and ¹⁸F-FDG PET/CT. The study aims to correlate radiotracer uptake with FRα expression and to demonstrate the superior performance of ⁸⁹Zr-DFO-Mirvetuximab in identifying and delineating ovarian cancer lesions compared to ¹⁸F-FDG

The primary objectives of the study are: 1. To delineate commonly utilized tumor metabolic alterations in ovarian cancer. These metabolic alterations will be explored for potentially targetable pathways to restore chemotherapy responsiveness. 2. To define the relationship between whole-body metabolic activity as measured via indirect calorimetry with ex vivo measure of tumor metabolic activity. The secondary objectives of the study are: 3. To evaluate longitudinal changes in whole-body metabolic activity over the course of cytotoxic chemotherapy and evaluate these changes as they relate to oncologic outcomes and treatment-free interval. 4. To examine the impact of tumor metabolic alterations on healthy non-malignant tissues and serum metabolites. 5. An additional exploratory objective is to collect data that will contribute to a more holistic understanding of the whole-body metabolic effects of ovarian cancer. Based on prior studies, surveys have been an effective method for capturing the social, psychological, and behavioral factors associated with the disease. It is possible that changes in metabolism and inflammation are mediated by these psychosocial factors that ultimately impact response to cancer therapy. It is hypothesized that whole-body metabolic activity as measured via indirect calorimetry can be utilized as a non-invasive surrogate to reflect tumor metabolic dysregulation in patients with ovarian cancer. Moreover, it is hypothesized that there will be an inverse relationship between treatment-free interval and the metabolic rate when measured at a whole-body level and an increased rate of glycolysis when measured within the tumor microenvironment. To address these hypotheses, the study will pursue the specific aims listed above.

The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are: * Is it feasible to use intermittent fasting during neoadjuvant chemotherapy? * Is it safe to use intermittent fasting during neoadjuvant chemotherapy? * Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy? Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes. Participants will: * Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy. * All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing. * Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week.

This is a multicenter, observational, retrospective and prospective study conducted within the REMO (Reggio Emilia - Modena) network in the Emilia-Romagna region (Italy), promoted by AUSL-IRCCS of Reggio Emilia. The study aims to evaluate the impact of surgical centralization and treatment strategies adopted during the COVID-19 pandemic on oncologic outcomes in patients diagnosed with the epithelial ovarian cancer (EOC) from 2018 to 2023. The retrospective component includes patients treated between 2018 and 2023, while the prospective component consists of clinical follow-up of those patients over the next five years.

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.

This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. At screening, each participant's tumor is assessed for expression of Mesothelin (MSLN), Folate Receptor alpha (FRalpha/FOLR1), and MUC16 (CA 125). Participants are assigned to the dual-target CAR-NK product that best matches their tumor antigen profile to reduce the risk of antigen escape.

This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of liposomal irinotecan combined with enlonstobart in patients with platinum-resistant recurrent ovarian cancer. Eligible female participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV, will receive liposomal irinotecan and enlonstobart every 2 weeks. Tumor assessment will be performed every 8 weeks. Participants may discontinue study treatment in the event of disease progression, intolerable toxicity, withdrawal of consent, or other reasons judged by the investigator.

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.

This prospective study aims to evaluate the feasibility and diagnostic performance of sentinel lymph node (SLN) mapping using indocyanine green (ICG) in patients undergoing surgery for early-stage epithelial ovarian cancer. Ovarian cancer is the most lethal gynecologic malignancy, and although systematic pelvic and paraaortic lymphadenectomy is considered a standard component of surgical staging. Moreover, systematic lymphadenectomy is associated with increased operative time, perioperative morbidity, and long-term complications such as lymphedema, without clear evidence of therapeutic benefit. SLN mapping has been successfully implemented in other gynecologic malignancies and may provide a less invasive alternative for lymph node assessment. In this study, patients undergoing laparotomy for adnexal masses will receive intraoperative ICG injection into the infundibulopelvic ligament on the affected side and into the cervix (at the 3 and 9 o'clock positions) following intraoperative confirmation of malignant epithelial tumor by frozen section analysis. SLN detection rates, anatomical distribution, and feasibility will be assessed. In addition, intraoperative and postoperative outcomes and potential complications related to the procedure will be evaluated. The results of this study are expected to contribute to the current evidence regarding the role of SLN mapping in early-stage epithelial ovarian cancer and may help reduce the need for systematic lymphadenectomy and its associated morbidity.

This study evaluates the safety, tolerability, and preliminary anti-tumor activity of EB-DUALNK, a dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy, in adults with recurrent or refractory epithelial ovarian cancer. Candidates for targeting include GD2, MUC1, PSMA, and mesothelin. After baseline biomarker assessment (tumor antigen expression), the program will select the most suitable dual-target pair for clinical testing. Participants will receive lymphodepleting chemotherapy followed by EB-DUALNK infusion and safety/response follow-up.