In the dose-optimization portion of the now-terminated phase 2/3 REFRaME-O1 trial, the antibody-drug conjugate luveltamab tazevibulin produced objective responses in patients with platinum-resistant ovarian cancer expressing folate receptor alpha, at…
In the randomized, phase 3 ENGOT-ov65/KEYNOTE-B96 trial, adding pembrolizumab to paclitaxel chemotherapy significantly improved BOTH progression-free survival (8.3 vs 7.2 months) AND overall survival (18.2 vs 14.0 months) in patients…
In the dose-optimization portion of the now-terminated phase 2/3 REFRaME-O1 trial, the antibody-drug conjugate luveltamab tazevibulin produced objective responses in patients with platinum-resistant ovarian cancer expressing folate receptor alpha, at…
In the randomized, phase 3 ENGOT-ov65/KEYNOTE-B96 trial, adding pembrolizumab to paclitaxel chemotherapy significantly improved BOTH progression-free survival (8.3 vs 7.2 months) AND overall survival (18.2 vs 14.0 months) in patients…
✓ Primary source cited
Last reviewed
Clinical Trials
Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.
Adults with recurrent, platinum-resistant ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing folate receptor alpha (FRα), who received 1-3 prior lines of therapy, enrolled in the dose-optimization portion of a phase 2/3 trial that has since been terminated before its planned randomized phase 3 portion began (see correction_note). Efficacy figures here are from the 25-patient cohort receiving the dosing regimen originally selected for further study.
Last reviewed
2026-08-13
Regulatory status by jurisdiction
Unspecified jurisdiction
Status
Investigational
Last verified
2026-08-13
This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.
REFRaME-O1 trial registry (phase 2/3 study of luveltamab tazevibulin in platinum-resistant ovarian cancer). NCT05870748.
Eligibility varies — review trial criteria.
FDA Approvals
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults with platinum-resistant, PD-L1-positive (CPS >=1) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had received one to two prior lines of systemic therapy, randomized to pembrolizumab plus paclitaxel (+/- bevacizumab) or placebo plus paclitaxel (+/- bevacizumab), in the randomized, double-blind, phase 3 ENGOT-ov65/KEYNOTE-B96 trial conducted at 187 sites in 25 countries.
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >=1), who have received one to two prior lines of systemic therapy.
Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study (The Lancet). DOI 10.1016/S0140-6736(26)00602-1, PMID 41974150.
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.