Salvage Systemic Therapy With or Without Stereotactic Ablative Radiotherapy for Recurrent Ovarian...
Recurrent Epithelial Ovarian CancerRationale Ovarian cancer is the 3rd most common gynecologic malignancy in Korea. The standard treatment is tumor debulking surgery with or without adjuvant chemotherapy. However, with a recurrence rate of 80%, the treatment results are the worst among gynecological cancers. The use of target and immune agents have demonstrated to improve survival. However, long-term maintenance of systemic therapy is often difficult because recurrent tumors do not respond uniformly to systemic therapy. In the 1980~1990s, whole abdomen irradiation had been tried and faded out owing to many side effects with the introduction of taxane. Efforts have been made to find the role of salvage radiation therapy (RT) in recurrent ovarian cancer. Involved field radiotherapy (IFRT) emerged to cover the gross tumor plus regional microscopic disease in addition to salvage chemotherapy. It showed high local control, provided chemotherapy holiday in selected cases, but did not prevent out-field progression. Stereotactic ABlative Radiotherapy (SABR) is the latest treatment using an intensity modulated technique to increase the fractional dose, reduces the number of treatments, and destroys the tumor with high accuracy. SABR-COMET study, a representative clinical study, showed a significant increase in overall survival in solid cancers. Objectives The primary objective; to evaluate whether the addition of SABR to standard salvage treatment significantly improves 3-year overall survival (OS) in patients with recurrent ovarian cancer. The secondary objectives; to check whether it significantly affects quality of life (Health-related QoL), patient-reported outcome (PRO) to develop an deep learning-based predictive model for the treatment response of ovarian cancer subjects using radiomic and genomic analysis. Study design Arm 1; Standard salvage therapy Subjects will continue to receive current salvage treatment suitable for subjects at the discretion of their doctor, considering the location and size of recurrence, and the patient's comorbidities. Arm 2; Standard salvage therapy+ SABR Subjects receive SABR for lesions found in imaging studies. Before or After SABR, standard salvage treatment continues as planned at the discretion of the doctor. Stratification factors The number of No ascites, Platinum-sensitive, Normal CA125 and ECOG0-1; 0~3 vs. 4 Location of the lesion; Lymph node lesion vs. Non-lymph node lesion PARP inhibitor; Used vs. Not used Randomization Arm 1 : Arm 2 = 1 : 2 Estimated Accrual : The sample size 270 was calculated by setting the sample size to a Type I error rate (α) of 0.05 and Statistical Power of 80% using 2-Sided Equity and log-rank test. Accurate time: 2 years, Follow-up: 3 years (total 5 years) Alpha = 0.05, Power = 80% 1 year drop-out: 5% per group 3 year survival proportion: RT group 74.42%, No RT group 58% Arm 1: Arm 2 = 1 : 2 ratio
IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial...
High Grade Ovarian CancerPrimary Peritoneal Cancer1 moreIMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
Study of REGN5668 Administered in Combination With Cemiplimab or REGN4018 in Adult Women With Recurrent...
Ovarian CancerFallopian Tube Cancer1 moreThe primary objectives of the study are: In the Dose Escalation Phase: To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5668 alone and in separate combinations with cemiplimab or REGN4018, in order to determine a maximally tolerated dose(s) (MTD) or recommended phase 2 dose(s) (RP2D) of these combinations In the Dose Expansion Phase: To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018, (separately by cohort and combination) as determined by the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 The secondary objectives of the study are: In the Dose Escalation Phase: To assess the preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as determined by ORR by RECIST 1.1 In the Dose Expansion Phase: To characterize the safety profile in each expansion cohort To characterize the PK of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) In both the Dose Escalation and Dose Expansion Phases: To assess preliminary efficacy of REGN5668 in combination with cemiplimab or REGN4018 (separately by cohort and combination) as measured by ORR based on immune based therapy RECIST (iRECIST), best overall response (BOR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) based on RECIST 1.1 and iRECIST To assess changes in CA-125 levels from baseline after treatment with REGN5668 in combinations with cemiplimab or REGN4018 (separately by cohort and combination) Immunogenicity of REGN5668, alone and in combinations with cemiplimab or REGN4018
Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT
Small Cell Ovarian CarcinomaSmall cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients...
Advanced Differentiated Thyroid Gland CarcinomaAdvanced Head and Neck Carcinoma61 moreThis phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.
A Study of NX-1607 in Adults With Advanced Malignancies
Ovarian CancerEpithelial13 moreThis is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Ovarian CancerPeritoneal Cancer1 moreThis Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.
Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously...
Ovarian CancerFallopian Tube Cancer3 moreThe purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment for these participants. Biomarkers are molecules such as genes (molecules that contain instructions for the development and function of cells in the body) and proteins that may be used to see how well a body responds to certain treatments.
Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer
Ovarian CancerSerous Ovarian CancerTo see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.
Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent...
Ovarian CancerThe primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer