Rina-S Plus Standard Care for Recurrent Ovarian Cancer
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
544 (estimated)
Sponsor
Genmab · Industry
Who this trial is looking for
This trial is looking for women with certain types of recurrent ovarian cancer to see how well a new treatment called Rina-S works. Participants will either receive Rina-S alone, Rina-S with another medication, the standard medication alone, or just monitoring without treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with high-grade serous or endometrioid ovarian cancer.
I have recurrent platinum-sensitive ovarian cancer.
I have completed platinum-based chemotherapy for my ovarian cancer.
I started this treatment no later than 8 weeks after my last chemotherapy.
I have achieved a complete or partial response to my last treatment.
You may not be able to join if
I have clear cell, mucinous, or low-grade ovarian tumors.
I have had more than 2 prior lines of systemic therapy.
My cancer progressed while on or after my platinum chemotherapy treatment.
I received another cancer treatment after my last chemotherapy and before randomization.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, b…
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.
Trial Locations
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Eligibility Criteria
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 prim…
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.
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