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Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06619236
Protocol IDs
GCT1184-02 (primary)
NCI-2024-09116
2024-514822-21
ENGOT-OV86
GOG-3107
jRCT2031250064
PRO1184-002
RAINFOL-OV2
Study Sponsor
Genmab

Summary

This phase 3 study will be conducted in different countries all over the world.

The purpose of this study is to compare how well Rina-S works against platinum-resistant
ovarian cancer compared to chemotherapy drugs that are already approved and used for
platinum-resistant ovarian cancer.

Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy
agents that are considered standard medical care. There is an equal (50:50) chance of
getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will
know what treatment they are assigned to until the first dose.

All participants will receive active drug; no one will be given placebo.

Eligibility

  1. Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  2. Participants may be enrolled regardless of FRa expression level.
  3. Participants must have received 1 to 4 prior lines of therapy.
  4. Participants must have received prior treatment with the following therapies:
  5. Platinum chemotherapy
  6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or due to precautions/intolerance
  7. Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
  8. Mirvetuximab soravtansine, if:
  9. Mirvetuximab soravtansine is available in the enrollment region, and
  10. The participant is eligible based on positive FRa expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and
  11. The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
  12. Participants must have platinum-resistant disease:
  13. Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of platinum-based therapy, and then progressed between > 91 days and = 183 days after the date of the last dose of platinum.
  14. Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum. Key

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.