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

NCT07564141 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: GCT1184-072025-524202-15GOG-3143ENGOT-ov103GEICO-177-OAPGOT-ov21LACOG 0126-EVA
• Study Type: interventional
• Target: 688
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 3 years

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 5 years

• PFS per RECIST v1.1, as Determined by Investigator

  Up to approximately 3 years

• Objective Response Rate (ORR) per RECIST v1.1

  Up to approximately 3 years

• Duration of Response (DOR) per RECIST v1.1

  Up to approximately 3 years

• Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)

  Up to approximately 3 years

Study Arms (2)

Arm 1: Rina-S ± Bevacizumab

EXPERIMENTAL

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

Biological: Rina-S; Drug: Bevacizumab

Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

ACTIVE COMPARATOR

Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.

Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: PLD

Interventions

Rina-S BIOLOGICAL

Intravenous (IV) infusion

Also known as: Rinatabart Sesutecan, GEN1184, PRO1184

Arm 1: Rina-S ± Bevacizumab

Bevacizumab DRUG

IV infusion

Arm 1: Rina-S ± Bevacizumab; Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

Carboplatin DRUG

IV infusion

Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

Gemcitabine DRUG

IV infusion

Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

Paclitaxel DRUG

IV infusion

Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

PLD DRUG

IV infusion

Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Genmab: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Carboplatin; Gemcitabine; Paclitaxel; 1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): November 1, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share