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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

BIOLOGICAL

Rina-S

Intravenous (IV) infusion

DRUG

Bevacizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

PLD

IV infusion

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-12-31
Completion
2031-11-30
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564141 on ClinicalTrials.gov