Rina-S + Standard of Care for Ovarian Cancer
(RAINFOL-04 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase 3 study will be conducted in different countries around the world with up to about 528 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.
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
This trial is for adults with high-grade ovarian cancer that responded to initial platinum therapy but later returned. They must have finished second-line platinum chemotherapy and shown improvement or stable disease. Those with BRCA mutations or HRD-positive cancer are eligible if they had a good response after first-line treatment.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Rina-S
Trial Overview
The study tests Rina-S alone, Rina-S plus Bevacizumab, or just Bevacizumab against standard monitoring in recurrent ovarian cancer patients post-second-line chemotherapy. It's a global Phase 3 trial without placebos, aiming to see how well Rina-S works when added to the current standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
GOG Foundation
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.