688 Participants NeededMy employer runs this trial

Rina-S With or Without Bevacizumab for Ovarian Cancer

(RAINFOL™-07 Trial)

Recruiting at 1 trial location
GT
Overseen ByGenmab Trial Information
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Genmab
Must be taking: PARPi
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 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.12345

Why 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?

SO

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

I have had PARP inhibitor maintenance therapy for my BRCA or HRD-positive cancer.
Participants must have measurable disease per RECIST v1.1 by investigator at baseline
All participants must provide a tumor specimen
See 3 more

Exclusion Criteria

My ovarian tumor is clear cell, mucinous, sarcomatous, mixed, or low-grade/borderline.
I have been treated with anti-angiogenic drugs other than bevacizumab or its biosimilars.
I have been treated with a drug targeting folate receptor alpha.
See 1 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 ± bevacizumab or investigator's choice of chemotherapy ± bevacizumab every 3 or 4 weeks per cycle

Variable, based on participant response
1 to 3 visits per 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
  • 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

Group I: Arm 1: Rina-S ± BevacizumabExperimental Treatment2 Interventions
Group II: Arm 2: Investigator Choice of Chemotherapy ± BevacizumabActive Control5 Interventions

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

Citations

Rina-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 ...

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; ...