Recruiting
Phase 3

Rina-S & Bevacizumab

Sponsor:

Genmab

Code:

NCT07225270

Conditions

Ovarian Cancer

Platinum-sensitive Ovarian Cancer

PSOC

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rina-S

Bevacizumab

Study Details

Brief summary:

This Phase 3 study will be conducted in different countries around the world with up to about 544 participants.

The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.

Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also 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 weeks). 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) for each participant will be different for every participant.

Conditions

Ovarian Cancer

Platinum-sensitive Ovarian Cancer

PSOC

Study ID

NCT07225270

Start date

Apr 3, 2026

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • Must have PSOC defined as progressive disease > 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy.
  • Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
  • Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
  • Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
  • Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.

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
  • More than 2 prior lines of systemic therapy.
  • Progression while on or following 2L platinum-based regimen prior to randomization.
  • Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.

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

Study Design

Enrollment

544 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rina-S + SOC

Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).

active comparator: SOC

Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).

Interventions

Rina-S

Intravenous (IV) infusion

Bevacizumab

IV infusion

Primary outcome measure

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, 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

Mt. Sinai Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33140

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Zangmeister Cancer Center

Recruiting

Columbus, Ohio, United States, 43219

More Information

Sponsor

Genmab

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genmab on 2026-08-04.