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

Part of paid clinical trials in Danbury, Connecticut.

Sponsor
Genmab
Study ID
NCT07564141
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Rina-S — BIOLOGICAL
    Intravenous (IV) infusion
  • Bevacizumab — DRUG
    IV infusion
  • Carboplatin — DRUG
    IV infusion
  • Gemcitabine — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion
  • PLD — DRUG
    IV infusion

Study Details

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. 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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Nov 30, 2031

Study Design

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

Arms

  • Experimental: Arm 1: Rina-S ± Bevacizumab
    Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
  • Active Comparator: Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab
    Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Danbury HospitalDanburyConnecticut06810-
ProHealth Care IncWaukeshaWisconsin53188-

Find similar trials in Danbury, CT

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Danbury Hospital· Danbury, CTProHealth Care Inc· Waukesha, WI

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