Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT07225270
Recruiting Phase 3

Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy

NCT07225270 · tracked via the Priya Life Science France tracker
Sponsor
Genmab
Phase
Phase 3
Started
2026-04-03
Last updated
2026-09-09

Condition(s) studied

Ovarian CancerPlatinum-sensitive Ovarian CancerPSOC

Investigational drug(s) / intervention(s)

Rina-S →Bevacizumab →

Rina-S: Intravenous (IV) infusion

Bevacizumab: IV infusion

Study summary

This Phase 3 study will be conducted in different countries around the world with up to about 544 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer. * Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of primary (first-line \[1L\]) platinum therapy. * Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment. * Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC. * Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy. * Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy. Key Exclusion Criteria: * Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors * More than 2 prior lines of systemic therapy. * Progression while on or following 2L platinum-based regimen prior to randomization. * Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Primary outcome measure(s)

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Blinded Independent Central Review (BICR) — Up to approximately 3 years

Trial sites (22)

FacilityCityRegionStatus
Mt. Sinai Comprehensive Cancer Center Miami Florida Recruiting
Sarasota Memorial Health Care System Sarasota Florida Recruiting
Greater Baltimore Medical Center Towson Maryland Recruiting
Miami Valley Hospital South Centerville Ohio Recruiting
Zangmeister Cancer Center Columbus Ohio Recruiting
UZ Leuven - Gasthuisberg Campus Leuven Belgium Recruiting
National Hospital Organization Hokkaido Cancer Center Sapporo Hokkaido Recruiting
Sapporo Medical University Hospital Sapporo Hokkaido Recruiting
Hyogo Cancer Center Akashi Hyōgo Recruiting
Mie University Graduate School Of Medicine Tsu Mie-ken Recruiting
Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka Recruiting
Saitama Medical University International Medical Center Hidaka Saitama Recruiting
The Jikei University Kashiwa Hospital Kashiwa Japan Recruiting
St Marianna University School of Medicine Kawasaki Japan Recruiting
Kurume University Hospital Kurume Japan Recruiting
Shizuoka Cancer Center Nagaizumi-chō Japan Recruiting
Niigata University Medical & Dental Hospital Niigata Japan Recruiting
Okayama University Hospital Okayama Japan Recruiting
Kitasato University Hospital Sagamihara Japan Recruiting
Tohoku University Hospital Sendai Japan Recruiting
The Cancer Institute Hospital of JFCR Tokyo Japan Recruiting
Kanagawa Prefectural Cancer Center Yokohama Japan Recruiting

On this site

📄 Avastin (bevacizumab) drug profile →

More Genmab trials in France

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) Active, not recruiting
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Active, not recruiting
A Phase 1 Trial of GEN1119 in Participants With Solid Tumors Recruiting
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome Active, not recruiting

Other trials for the same condition

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) Recruiting
A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) Recruiting
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Active, not recruiting
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07225270 on ClinicalTrials.gov ↗ ← All trials in France