Rina-S With or Without Bevacizumab for Ovarian Cancer
(RAINFOL™-07 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, Rina-S, for ovarian cancer. Participants will receive either Rina-S alone, Rina-S with bevacizumab (a targeted therapy), or standard chemotherapy options with or without bevacizumab. The goal is to determine which treatment combination is most effective. Individuals with high-grade serous or endometrioid ovarian cancer that has recurred after initial platinum-based chemotherapy may qualify. Participants will regularly visit the study clinic for monitoring and can continue treatment as long as it remains beneficial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that Rina-S is generally well-tolerated. Research indicates it is safe for use on its own, with patients not experiencing serious eye or lung problems, which are common concerns. Rina-S had manageable side effects, and no unexpected side effects appeared.
Bevacizumab, used with other treatments, has already received FDA approval for various cancers, indicating it is reasonably safe. However, it can sometimes cause high blood pressure or affect the kidneys.
Overall, both Rina-S and bevacizumab have undergone prior study, and their safety is considered manageable, meaning most side effects can be controlled or treated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Rina-S for ovarian cancer because it potentially offers a novel approach by either being used alone or in combination with bevacizumab, a well-known drug that targets blood vessels feeding tumors. Unlike traditional treatments like carboplatin paired with other chemotherapy agents, Rina-S could provide a unique mechanism targeting cancer cells differently. This new approach may enhance effectiveness or reduce side effects compared to existing chemotherapy options.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that Rina-S may effectively treat ovarian cancer. One study found that up to 50% of patients experienced significant tumor shrinkage. Additionally, about 86.4% of patients maintained stable disease, with no progression. Some patients even achieved complete responses, where the cancer appeared to disappear entirely. In this trial, participants in one arm will receive Rina-S with or without Bevacizumab. These early results suggest that Rina-S could be a strong option for managing ovarian cancer, especially when other treatments have failed.23467
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 serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer that has come back at least 6 months after finishing first platinum-based chemo. Participants must be in good physical condition and have measurable disease. Prior PARP inhibitor therapy is required for certain genetic types.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rina-S ± bevacizumab or investigator's choice of chemotherapy ± bevacizumab every 3 or 4 weeks per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Carboplatin
- Gemcitabine
- Paclitaxel
- PLD
- Rina-S
Trial Overview
The study compares Rina-S (alone or with bevacizumab) to standard platinum-based chemotherapy (with or without bevacizumab) as a second-line treatment for recurrent, platinum-sensitive ovarian cancer. Treatments are assigned by chance and monitored closely.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
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
Citations
1.
cancernetwork.com
cancernetwork.com/view/rina-s-elicits-encouraging-antitumor-activity-in-advanced-ovarian-cancerRina-S Elicits Encouraging Antitumor Activity in Advanced ...
4.5% and 11.1% of patients in each respective cohort achieved complete responses (CRs), and 18.2% and 44.4% had partial responses (PRs).
A phase 3, open-label, randomized study of rinatabart ...
Rina-S 120 mg/m2 every 3 weeks (Q3W) showed encouraging anti-tumor activity with a 50% objective response rate (ORR; 95% CI, 26-74), including ...
Rina-S Displays Early Efficacy in Advanced Ovarian Cancer
The disease control rates in the 100 mg/m 2 and 120 mg/m 2 groups were 86.4% Rina-S at the 120 mg/m 2 [dose level] showed a very encouraging ...
NCT06619236 | Study to Assess the Efficacy of Rina-S ...
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved ...
A phase 3, open-label, randomized study of rinatabart ...
Rina-S 120 mg/m2 every 3 weeks (Q3W) showed encouraging anti-tumor activity with a 50% objective response rate (ORR; 95% CI, 26-74), including 1 complete ...
6.
ir.genmab.com
ir.genmab.com/news-releases/news-release-details/genmab-presents-safety-and-tolerability-rinatabart-sesutecan/Genmab Presents the Safety and Tolerability of Rinatabart ...
“Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care ...
719MO A phase I/II study of rinatabart sesutecan (Rina-S ...
As of 02 April 2024, 53 pts were treated in Part A. Of 32 pts with OC, median number of prior therapies was 5 (1–14); 75% had received bevacizumab; ...
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