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)
Progression-Free Survival (PFS) — Up to approximately 1.5 years PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Trial sites (177)
Facility
City
Region
Status
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
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.
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