528 Participants Needed

Rina-S + Standard of Care for Ovarian Cancer

(RAINFOL-04 Trial)

Recruiting at 1 trial location
GT
Overseen ByGenmab Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Genmab
Must be taking: Platinum-based chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, Rina-S, against ovarian cancer when combined with standard care. Participants will receive either Rina-S alone, Rina-S with bevacizumab (a current treatment), or just bevacizumab. The goal is to determine if Rina-S can manage the cancer more effectively. The trial seeks individuals with ovarian cancer who have undergone specific chemotherapy treatments and whose cancer has not worsened recently. Participants will visit the clinic regularly for tests and monitoring to ensure the treatment's safety and effectiveness. 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 if you need to stop taking your current medications. However, it mentions that participants should not receive any other systemic anticancer treatment (except bevacizumab) after their last dose of second-line platinum-based chemotherapy and before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Rina-S is generally well-tolerated by patients. Earlier studies found that the side effects of Rina-S were manageable, with no new safety issues identified. While some side effects might occur, they are usually not serious and can be controlled. Rina-S has been tested in people with various types of solid tumors, providing a better understanding of its safety. Individual experiences may vary, and the study team will closely monitor participants for any side effects.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for ovarian cancer, which typically include chemotherapy and bevacizumab, Rina-S is being tested for its potential to enhance the efficacy of these existing therapies. Researchers are excited about Rina-S because it may offer a novel mechanism of action that targets cancer cells more precisely. This could potentially improve outcomes by reducing tumor growth and delaying progression, providing new hope for patients.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that Rina-S, which participants in this trial may receive, holds promise for treating ovarian cancer. In one study, 55.6% of patients experienced tumor shrinkage with Rina-S. Another study found that up to 88.9% of patients had either tumor shrinkage or stability. These findings suggest that Rina-S could effectively manage ovarian cancer, especially when combined with standard treatments like bevacizumab, which is part of the standard care in this trial.12567

Who Is on the Research Team?

SO

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

Key
My cancer is confirmed to be high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
My cancer worsened 6 months after my first platinum treatment.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rina-S monotherapy, Rina-S plus bevacizumab, bevacizumab alone, or no treatment (observation) as maintenance therapy

Variable, based on participant response
1 to 3 visits per 3-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Variable, based on participant response

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

Group I: Rina-S + SOCExperimental Treatment2 Interventions
Group II: SOCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials
76
Recruited
15,300+

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

Trials
48
Recruited
18,500+

Citations

Investigational Rinatabart Sesutecan (Rina-S®) Continues ...

Rina-S 120 mg/m2 Q3W at a median on-study follow-up of 48 weeks showed encouraging antitumor activity; the confirmed ORR was 55.6% (95% CI: 30.8 ...

A phase 3, open-label, randomized study of rinatabart ...

In cohort B1 of a phase 1/2 trial (NCT05579366), Rina-S 120 mg/m² every 3 weeks (Q3W) showed encouraging anti-tumor activity with a 50% ...

Rina-S Displays Early Efficacy in Advanced Ovarian Cancer

Patients who received 100 mg/m 2 of Rina-S (n = 22) achieved a confirmed objective response rate (ORR) of 22.7% (95% CI, 7.8%-45.4%), including a 4.5% ...

Rina-S Elicits Encouraging Antitumor Activity in Advanced ...

Data showed a disease control rate (DCR) of 86.4% (95% CI, 65.1%-97.1%) and 88.9% (95% CI, 65.3%-98.6%) in each cohort. Rinatabart sesutecan ...

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 ...

Genmab Announces New Data Demonstrating ...

The study showed that at a median study follow-up of one year, treatment with Rina-S 100 mg/m² every 3 weeks (Q3W) resulted in a 50.0% ...

NCT05579366 | Rinatabart Sesutecan (Rina-S, PRO1184 ...

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.