Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
NCT06040970
Adnexal Diseases, Endocrine Gland Neoplasms
New York, United States
View Trial DetailsNCT Number: NCT06836219
This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026.
* Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy. * Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.
Interested in participating?
Request Info18 year and older
Female
Observational
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S., Bari, BA, Italy
This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination status using a validated HRD test between January 2021 and January 2026:
Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.
Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice. Alive patients who have finished the first line treatment (including maintenance) with or without disease progression while signing the informed consent form will be enrolled retrospectively. Alive patients candidate to receive a first line therapy will be enrolledprospectively as soon as molecular data (BRCA status and HRD) are available.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Until 3 years from enrollment
The clinical outcomes that will be measured in both study cohorts are:
progression-free survival (PSF) as the time from treatment's start to disease progression or death for any cause
Time frame: Until 3 years from enrollment
The clinical outcomes that will be measured in both study cohorts are:
overall survival (OS) as the time from treatment's start to death for any cause
Time frame: Until 3 years from enrollment
Toxicity evaluated according to CTCAE vers 5.0
Time frame: Until 3 years from enrollment
Percentage of patients with dose reductions
Time frame: Until 3 years from enrollment
Percentage of patients with dose interruptions due to toxicity
Time frame: Until 3 years from enrollment
Percentage of patients with treatment discontinuations due to toxicity
Time frame: Until 3 years from enrollment
Toxicity according to initial dose of targeted agents
Time frame: Until 3 years from enrollment
Incidence of myelodysplastic syndrome and acute myeloid leukaemia in patients receiving PARPi
Time frame: Until 3 years from enrollment
according to disease stage
Time frame: Until 3 years from enrollment
according to surgical timing
Time frame: Until 3 years from enrollment
according to residual disease after surgery in each cohort
Time frame: Until 3 years from enrollment
Describe the clinical characteristics of patients for which the combination therapy was offered (Cohort A)
Time frame: Until 3 years from enrollment
Describe the treatment approach to HRP patients in a real word scenario in Italy (Cohort B)
Contact information is provided by the study sponsor or research team.
BeLIVE S BeLIVE Service
CONTACT
Michele B Michele Bartoletti, MD
CONTACT
+39 334 500 7736 ext. 334 500 7736
Consorzio Oncotech
Other
Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study
Acronym: BeLIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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