Trials Today

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

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

Platinum-resistant Ovarian Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: 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 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 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 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 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

Arm	Description	Assigned 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 5879400, Alaska 5879092 99508

Arizona Center for Cancer Care (ACCC) - Biltmore
Scottsdale 5313457, Arizona 5551752 85251

University of Arizona Cancer Center - Research and Administration at Main Campus
Tucson 5318313, Arizona 5551752 85724

Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
Burbank 5331835, California 5332921 91505

University of California San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093

USCF Mission Bay
San Francisco 5391959, California 5332921 94158

Kaiser Permanente - Vallejo Medical Center
Vallejo 5405380, California 5332921 94589

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06106

Yale School of Medicine
New Haven 4839366, Connecticut 4831725 06510

Norwalk Hospital
Norwalk 4839822, Connecticut 4831725 06850

SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers 4155995, Florida 4155751 33901-8108

Mount Sinai Comprehensive Cancer Center
Miami Beach 4164143, Florida 4155751 33140

Orlando Health Cancer Institute - Downtown Orlando
Orlando 4167147, Florida 4155751 32806

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239

SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach 4177887, Florida 4155751 33401

Winship Cancer Institute of Emory University
Atlanta 4180439, Georgia 4197000 30322

Northside Hospital Atlanta
Atlanta 4180439, Georgia 4197000 30342

Augusta University Georgia Cancer Center
Augusta 4180531, Georgia 4197000 30912

Kapi'olani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96826

Northwest Cancer Center - Dyer
Dyer 4919820, Indiana 4921868 46311

University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160

HCA Midwest Health
Overland Park 4276873, Kansas 4273857 66211

St. Elizabeth Healthcare - Edgewood
Edgewood 4290873, Kentucky 6254925 41017

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Louisiana State University Health Sciences Center (LSU Health) - New Orleans
New Orleans 4335045, Louisiana 4331987 70112

Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
Shreveport 4341513, Louisiana 4331987 71103

Maine Medical Center Cancer Institute- Scarborough
Scarborough 4977882, Maine 4971068 04074-7172

Holy Cross Health - Holy Cross Hospital
Silver Spring 4369596, Maryland 4361885 20910

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Barbara Ann Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

Corewell Health (Spectrum Health)
Grand Rapids 4994358, Michigan 5001836 49503

Saint Joseph Mercy Ann Arbor Hospital
Ypsilanti 5015688, Michigan 5001836 48197

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68105

Center of Hope
Reno 5511077, Nevada 5509151 89511

Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760 07666

University of New Mexico Comprehensive Cancer Center
Albuquerque 5454711, New Mexico 5481136 87131

Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14203

Perlmutter Cancer Center - 38th Street
New York 5128581, New York 5128638 10016

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York 5128581, New York 5128638 10016

Herbert Irving Comprehensive Cancer Center
New York 5128581, New York 5128638 10032

New York-Presbyterian - Weill Cornell Medical Center
New York 5128581, New York 5128638 10065

James P. Wilmot Cancer Center
Rochester 5134086, New York 5128638 14642

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27705

FirstHealth Outpatient Cancer Center
Pinehurst 4485272, North Carolina 4482348 28374

University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109

Cleveland Clinic Main Campus
Cleveland 5150529, Ohio 5165418 44195

JamesCare Gynecologic Oncology at Mill Run
Hilliard 5157588, Ohio 5165418 43026

Legacy Good Samaritan Medical Center
Portland 5746545, Oregon 5744337 97210

USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland 5746545, Oregon 5744337 97227

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239

St. Luke's University Health Network
Bethlehem 5180225, Pennsylvania 6254927 18015

Penn State Health Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111

Allegheny Health Network - West Penn Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15224

Jefferson Health - Asplundh Cancer Pavilion
Willow Grove 5219619, Pennsylvania 6254927 19090

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
Abilene 4669635, Texas 4736286 79606

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
Austin 4671654, Texas 4736286 78731

University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth 4691930, Texas 4736286 76104

Inova Schar Cancer Institute
Fairfax 4758023, Virginia 6254928 22031

USOR - Virginia Oncology Associates - Norfolk
Norfolk 4776222, Virginia 6254928 23502

Kadlec Clinic - Hematology and Oncology
Kennewick 5799610, Washington 5815135 99336

Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109

Providence Sacred Heart Medical Center
Spokane 5811696, Washington 5815135 99204

West Virginia University Cancer Institute
Morgantown 4815352, West Virginia 4826850 26506-9600

University of Wisconsin - Madison
Madison 5261457, Wisconsin 5279468 53706

UPR Comprehensive Cancer Center Hospital
Monacillo, San Juan 4568138, Puerto Rico 00927

More Details

NCT ID: NCT06619236
Status: Recruiting
Sponsor: Genmab

Study Contact

Genmab Trial Information
+4570202728
clinicaltrials@genmab.com