A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resist… (NCT07286266) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)
450 participantsStarted 2026-06-24
Plain-language summary
This study specifically aims to evaluate how well GSK5733584 works in treating ovarian cancer compared to standard treatments. The study also assesses whether GSK5733584 is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).
* Has epithelial ovarian, primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.
Platinum-resistance is defined as follows:
* Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from \>3 months to ≤6 months after the last dose of platinum therapy.
* Participants who have received \>1 line of platinum therapy must have progressed on or ≤6 months after the date of the last dose of platinum therapy.
• Has received at least 1 but no more than 3 prior lines of systemic anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment. Participants who received mirvetuximab soravtansine as prior therapy are permitted to have received up to 4 prior lines. Prior lines of therapy are defined as follows:
* Adjuvant ± neoadjuvant are considered one line of therapy.
* Maintenance therapy (e.g., bevacizumab, \[Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor (PARPi)\] will be considered as part of the preceding line of therapy (i.e., not …