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Comparing Rina-S to standard chemotherapy for platinum-resistant ovarian cancer

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

PHASE3 · Genmab · NCT06619236

This study is testing if a new drug called Rina-S can help people with platinum-resistant ovarian cancer more than standard chemotherapy treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment530 (estimated)
Ages18 Years and up
SexFemale
SponsorGenmab (industry)
Drugs / interventionsbevacizumab, Mirvetuximab, chemotherapy
Locations21 sites (La Jolla, California and 20 other locations)
Trial IDNCT06619236 on ClinicalTrials.gov

What this trial studies

This phase 3 study aims to evaluate the efficacy of Rina-S, an antibody-drug conjugate, in treating patients with platinum-resistant ovarian cancer. Participants will be randomly assigned to receive either Rina-S or one of four approved chemotherapy agents, ensuring that all receive active treatment without a placebo. The study will take place across multiple countries, allowing for a diverse patient population. The primary goal is to determine how well Rina-S performs compared to existing treatment options.

Who should consider this trial

Good fit: Ideal candidates include individuals with high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have received 1 to 4 prior lines of therapy.

Not a fit: Patients who have not received prior platinum chemotherapy or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with platinum-resistant ovarian cancer.

How similar studies have performed: Other studies have shown promise with similar antibody-drug conjugate approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
* Participants may be enrolled regardless of FRα expression level.
* Participants must have received 1 to 4 prior lines of therapy.
* Participants must have received prior treatment with the following therapies:

  * Platinum chemotherapy
  * 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
  * 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
  * Mirvetuximab soravtansine, if:

    * Mirvetuximab soravtansine is available in the enrollment region, and
    * The participant is eligible based on positive FRα expression per Food and Drug Administration (FDA)-approved (or local equivalent) test, and
    * 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.
* Participants must have platinum-resistant disease:

  * 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.
  * 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 Exclusion Criteria:

* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
* Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
* Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management. Enrollment of participants with an indwelling peritoneal catheter must be discussed with the medical monitor to determine eligibility.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where this trial is running

La Jolla, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Platinum-resistant Ovarian Cancer, antibody-drug conjugate, folate receptor alpha, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, folate receptor, platinum-resistant ovarian cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.