General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT07225270

Background Information

Before the start of this trial more than 364 participants in other trials have been given the trial drug Rina-S, of which 277 participants received Rina-S as monotherapy (by itself) across many dose levels and 87 participants received Rina-S in combination with other anticancer medicines. 

In this trial, Genmab wants to find out how well Rina-S works against your ovarian cancer and compare it to the usual treatment that patients with your type of cancer receive. The usual cancer treatment is also called Standard of Care and is abbreviated SoC in this Informed Consent Form. Genmab also wants to learn more about the potential side effects participants may get when they are given the trial drug Rina‑S. 

The trial consists of 2 groups.  One group will be given the trial drug Rina-S in combination with SoC and the other group will only receive SoC. In both groups, the SoC can be either: 

  • continued treatment with a drug called bevacizumab, or 

  • no further treatment (just observation with regular check-ups).   

Approximately 528 participants will take part in this trial. Each participant will be placed into one of the 2 groups by chance (this is called randomization). About 264 participants will be in each group. 

The results of this trial may be used for further development of Rina-S. They can also be used to get the trial drug approved for cancer treatment.  

The trial will be run at clinics/hospitals worldwide.

Offered At

8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Saveri Bhattacharya, DO

Eligibility Information

  • Must sign an ICF indicating that the purpose of the trial and the procedures required for the trial are understood and indicating that the participant is willing to participate in the trial. Where required by local or country-specific regulations, each participant must sign a separate ICF indicating agreement to provide samples for genomic biomarker analysis (DNA and RNA).
  • Be at least 18 (or the legal age of consent in the jurisdiction in which the trial is taking place) years of age.
  • Must have histologically or cytologically confirmed high-grade serous or endometrioid 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 (1L) platinum therapy.
  • Participants with known BRCA-mutated (somatic or germline) or HRD-positive ovarian cancer who achieved CR/NED or 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 have received ≥ 4 cycles of platinum-based chemotherapy in the 1L treatment and received no less than 4 and no more than 8 cycles of platinum-based chemotherapy in the 2L treatment.
  • Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.

Ineligibility Information

  • 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. Lines of prior anticancer therapy are counted with the following considerations:
    • Neoadjuvant and/or adjuvant therapy are considered 1 line of therapy if they correspond to a fully predefined regimen.
    • Prior induction plus maintenance is considered 1 line of therapy.
    • Hormonal therapy alone (ie, without chemotherapy) will not be counted as a separate line of therapy.
    • Change due to toxicity will be considered part of the proceeding line of 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.
  • Prior therapy with an ADC containing a topoisomerase 1 inhibitor.
  • Participant has received prior therapy with an ADC targeting FRα (eg, mirvetuximab soravtansine).
  • Prior radiation therapy to ≥ 25% of the bone marrow or with a wide field of radiation within 12 weeks of the planned first dose of study treatment.
  • Prior antitumor treatments must have a washout period of 2 weeks for small molecules and 4 weeks for antibody-based therapeutics prior to the planned first dose of study drug.
  • Radiotherapy or major surgery that is not completed 2 weeks prior to the planned first dose of study drug.
  • Concurrent participation in another clinical study of investigational therapy. Participation in long-term survival follow-up from a prior study that does not require ongoing laboratory or imaging assessments is allowed.