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Platinum-Sensitive Ovarian CancerPhase 3RAINFOL™-07NCT07564141

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

A Phase 3 study testing Rina-S, Bevacizumab and Carboplatin in people with Platinum-Sensitive Ovarian Cancer and Ovarian Cancer, run by Genmab at 9 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Rina-S, Bevacizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
688 participants
Where
9 sitesin 2 countries
Study dates
28 Aug 2026to Nov 2031
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
  • Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy.
  • Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
  • Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
  • All participants must provide a tumor specimen.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.

Who cannot join

  • Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
  • Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
  • Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
  • Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).
  • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Genmab Trial Information contact

+4570202728

clinicaltrials@genmab.com

9 sites in 2 countries

United States6 sites, 6 recruiting

  • Alliance Cancer Specialists, PC

    Bensalem, Pennsylvania, 19020

    Recruiting

  • Danbury Hospital

    Danbury, Connecticut, 06810

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Recruiting

  • Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.)

    Tigard, Oregon, 97223

    Recruiting

  • ProHealth Care Inc

    Waukesha, Wisconsin, 53188

    Recruiting

Other trials in United States

Japan3 sites, 3 recruiting

  • Niigata Cancer Center Hospital

    Chuo Ku Niigata, Niigata, 951-8566

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, Koto City, 135-8550

    Recruiting

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

    Recruiting

Other trials in Japan

About this study

Official title: A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

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.

Read more

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.

Read the detailed description

This is a global, open-label, randomized, Phase 3 study of Rina-S ± bevacizumab versus investigator's choice (IC) ± bevacizumab as second-line (2L) treatment in participants with recurrent platinum-sensitive ovarian cancer (PSOC).

Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07564141
Study groupRoleWhat they receive
Arm 1: Rina-S ± BevacizumabExperimentalParticipants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Receives: Biological: Rina-S; Drug: Bevacizumab
Arm 2: Investigator Choice of Chemotherapy ± BevacizumabActive comparatorParticipants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: PLD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)

    Measured: Up to approximately 3 years

Secondary outcomes (10)

  1. Overall Survival (OS)

    Measured: Up to approximately 5 years

  2. PFS per RECIST v1.1, as Determined by Investigator

    Measured: Up to approximately 3 years

  3. Objective Response Rate (ORR) per RECIST v1.1

    Measured: Up to approximately 3 years

  4. Duration of Response (DOR) per RECIST v1.1

    Measured: Up to approximately 3 years

  5. Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)

    Measured: Up to approximately 3 years

  6. Time to First Subsequent Therapy (TFST)

    Measured: Up to approximately 3 years

  7. Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria

    Measured: Up to approximately 3 years

  8. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 3 years

  9. Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)

    Measured: Baseline up to approximately 3 years

  10. Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start28 Aug 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
688 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564141
Sponsor's protocol ID
GCT1184-07
Other IDs
2025-524202-15-00, jRCT2021260025, GOG-3143, ENGOT-ov103, GEICO-177-O, APGOT-ov21, LACOG 0126-EVA, 2025
Acronym
RAINFOL™-07
Status last verified
Oct 2026
First submitted
27 Apr 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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