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

Part of paid clinical trials in Miami, Florida.

Sponsor
Genmab
Study ID
NCT07225270
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rina-S — DRUG
    Intravenous (IV) infusion
  • Bevacizumab — DRUG
    IV infusion

Study Details

This Phase 3 study will be conducted in different countries around the world with up to about 528 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.

Key Dates

Start date
Apr 3, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
528 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rina-S + SOC
    Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
  • Active Comparator: SOC
    Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Investigator Assessment [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mt. Sinai Comprehensive Cancer CenterMiamiFlorida33140-
Sarasota Memorial Health Care SystemSarasotaFlorida34239-
Miami Valley Hospital SouthCentervilleOhio45459-
Zangmeister Cancer CenterColumbusOhio43219-

Find similar trials in Miami, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mt. Sinai Comprehensive Cancer Center· Miami, FLSarasota Memorial Health Care System· Sarasota, FLMiami Valley Hospital South· Centerville, OHZangmeister Cancer Center· Columbus, OH

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