Recruiting
Phase 3

Rina-S & Bevacizumab

Sponsor:

Genmab

Code:

NCT07564141

Conditions

Platinum-Sensitive Ovarian Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rina-S

Bevacizumab

Carboplatin

Gemcitabine

Paclitaxel

Study Details

Brief summary:

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.

The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.

Participants will receive either:

  • Rina-S monotherapy (by itself),
  • Rina-S plus bevacizumab,
  • investigator's choice chemotherapy (by itself) (standard of care), or
  • investigator's choice chemotherapy plus bevacizumab (standard of care).

No participants will be given placebo. Participants will participate in 1 of 2 arms.

The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.

The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Conditions

Platinum-Sensitive Ovarian Cancer

Ovarian Cancer

Study ID

NCT07564141

Start date

Aug 28, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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 (FRα).

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Design

Enrollment

688 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Rina-S ± Bevacizumab

Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).

active comparator: 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.

Interventions

Rina-S

Intravenous (IV) infusion

Bevacizumab

IV infusion

Carboplatin

IV infusion

Gemcitabine

IV infusion

Paclitaxel

IV infusion

PLD

IV infusion

Primary outcome measure

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Genmab Trial Information

+4570202728clinicaltrials@genmab.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Danbury Hospital

Recruiting

Danbury, Connecticut, United States, 06810

Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.)

Recruiting

Tigard, Oregon, United States, 97223

Alliance Cancer Specialists, PC

Recruiting

Bensalem, Pennsylvania, United States, 19020

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

ProHealth Care Inc

Recruiting

Waukesha, Wisconsin, United States, 53188

More Information

Sponsor

Genmab

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Genmab on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.