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Clinical Trials in the USA / NCT06619236
Active, not recruiting Phase 3

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

NCT06619236 · tracked via the Priya Life Science USA tracker
Sponsor
Genmab
Phase
Phase 3
Started
2025-02-07
Last updated
2026-09-09

Condition(s) studied

Platinum-resistant Ovarian Cancer

Investigational drug(s) / intervention(s)

Rina-SPaclitaxelTopotecanPegylated liposomal doxorubicin (PLD)Gemcitabine

Rina-S: Intravenous (IV) infusion

Paclitaxel: IV infusion

Topotecan: IV infusion

Pegylated liposomal doxorubicin (PLD): IV infusion

Gemcitabine: IV infusion

Study 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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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 progressed radiographically on or after their most recent line of therapy. * Participants must have received prior treatment with the following therapies: * Platinum chemotherapy * Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) 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, 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 adjuvant 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 a protocol defined number of 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. * Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (177)

FacilityCityRegionStatus
Alaska Women's Cancer Care Anchorage Alaska
Arizona Center for Cancer Care (ACCC) - Biltmore Scottsdale Arizona
University of Arizona Cancer Center - Research and Administration at Main Campus Tucson Arizona
Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center Burbank California
University of California San Diego Moores Cancer Center La Jolla California
USCF Mission Bay San Francisco California
Kaiser Permanente - Vallejo Medical Center Vallejo California
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora Colorado
Hartford Hospital Hartford Connecticut
Yale School of Medicine New Haven Connecticut
Norwalk Hospital Norwalk Connecticut
SCRI - Florida Cancer Specialists - South Region Research Office Fort Myers Florida
Mount Sinai Comprehensive Cancer Center Miami Beach Florida
Orlando Health Cancer Institute - Downtown Orlando Orlando Florida
Sarasota Memorial Hospital Sarasota Florida
SCRI - Florida Cancer Specialists - West Palm Beach West Palm Beach Florida
Winship Cancer Institute of Emory University Atlanta Georgia
Northside Hospital Atlanta Atlanta Georgia
Augusta University Georgia Cancer Center Augusta Georgia
Kapi'olani Medical Center for Women and Children Honolulu Hawaii
Northwest Cancer Center - Dyer Dyer Indiana
University of Kansas Cancer Center Kansas City Kansas
HCA Midwest Health Overland Park Kansas
St. Elizabeth Healthcare - Edgewood Edgewood Kentucky
Baptist Health Lexington Lexington Kentucky
Louisiana State University Health Sciences Center (LSU Health) - New Orleans New Orleans Louisiana
Trials365, LLC (Gynecologic Oncology Associates-Shreveport) Shreveport Louisiana
Maine Medical Center Cancer Institute- Scarborough Scarborough Maine
Holy Cross Health - Holy Cross Hospital Silver Spring Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
Barbara Ann Karmanos Cancer Institute Detroit Michigan
Corewell Health (Spectrum Health) Grand Rapids Michigan
Saint Joseph Mercy Ann Arbor Hospital Ypsilanti Michigan
University of Nebraska Medical Center Omaha Nebraska
Center of Hope Reno Nevada
Holy Name Medical Center Teaneck New Jersey
University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico
Roswell Park Comprehensive Cancer Center Buffalo New York
Perlmutter Cancer Center - 38th Street New York New York

+ 137 more sites — see the full list on the official registry below.

More Genmab trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619236 on ClinicalTrials.gov ↗ ← All trials in the USA