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A Randomized, Open-label, Phase 3 Study of Rina-S +/- Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy +/- Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer (RAINFOL (TM) -07)

Clinical trial contact

ICON Clinical Research GK

Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan

Japan-Chiken@iconplc.com

Clinical trial contact

ICON Clinical Research GK

Kyutaromachi 4-chome 1-3, Chuo-ku, Osaka city, Osaka 541-0056, Japan

+81-6-4560-2001

Japan-Chiken@iconplc.com

Recruiting

Aug. 31, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel >= 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy.
Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
All participants must provide a tumor specimen.
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.

Note: Other protocol-defined Inclusion criteria may apply.

Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
Participant has received prior therapy with an ADC targeting folate receptor alpha (FRalpha).

Note: Other protocol-defined Exclusion criteria may apply.

Female

Platinum-Sensitive Ovarian Cancer, Ovarian Cancer

Arm 1: Rina-S +/- Bevacizumab
Participants will receive Rina-S +/- bevacizumab once every 3 weeks (Q3W).

Arm 2: Investigator Choice of Chemotherapy +/- Bevacizumab
Participants will receive carboplatin plus gemcitabine +/- bevacizumab, carboplatin plus paclitaxel +/- bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) +/- bevacizumab.

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)

Overall Survival (OS)
PFS per RECIST v1.1, as Determined by Investigator
Objective Response Rate (ORR) per RECIST v1.1
Duration of Response (DOR) per RECIST v1.1
Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
Time to First Subsequent Therapy (TFST)
Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire

+81-22-346-0325

July. 21, 2026

No

Czech Republic/Finland/France/Germany/Hungary/Ireland/ Italy/ Lithuania/Netherland/Poland/Spain/UK/Canada/US/Brazil/Australia/Korea/Singapore/Taiwan/Greece