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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rina-S
  • Drug: Rina-S
    Intravenous (IV) infusion
    Other names:
    • PRO1184
    • Rinatabart Sesutecan
    • GEN1184
Active Comparator
Investigator's Choice
  • Drug: Paclitaxel
    IV infusion
  • Drug: Topotecan
    IV infusion
  • Drug: Pegylated liposomal doxorubicin (PLD)
    IV infusion
  • Drug: Gemcitabine
    IV infusion

Recruiting Locations

Alaska Women's Cancer Care
Anchorage, Alaska 99508

Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Burbank, California 91505

University of California San Diego Moores Cancer Center
La Jolla, California 92093

USCF Mission Bay
San Francisco, California 94158

Hartford Hospital
Hartford, Connecticut 06106

Norwalk Hospital
Norwalk, Connecticut 06850

Orlando Health Cancer Institute - Downtown Orlando
Orlando, Florida 32806

Sarasota Memorial Hospital
Sarasota, Florida 34239

SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach, Florida 33401

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322

Northwest Cancer Center - Dyer
Dyer, Indiana 46311

HCA Midwest Health
Overland Park, Kansas 66211

St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky 41017

Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
Shreveport, Louisiana 71103

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201

Saint Joseph Mercy Ann Arbor Hospital
Ypsilanti, Michigan 48197

Center of Hope
Reno, Nevada 89511

Holy Name Medical Center
Teaneck, New Jersey 07666

University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131

Perlmutter Cancer Center - 38th Street
New York, New York 10016

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York 10016

Duke Cancer Institute
Durham, North Carolina 27705

FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374

MetroHealth Medical Center
Cleveland, Ohio 44109

JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026

Legacy Good Samaritan Medical Center
Portland, Oregon 97210

USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon 97227

Avera Cancer Institute
Sioux Falls, South Dakota 57105

SCRI Oncology Partners
Nashville, Tennessee 37203

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
Abilene, Texas 79606

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
Austin, Texas 78731

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth, Texas 76104

USOR - Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502

West Virginia University Cancer Institute
Morgantown, West Virginia 26506-9600

More Details

NCT ID
NCT06619236
Status
Recruiting
Sponsor
Genmab

Study Contact

Genmab Trial Information
+4570202728
clinicaltrials@genmab.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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