Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06619236

PHASE3

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

Sponsor: Genmab

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

584

Start Date

2025-02-07

Completion Date

2027-10

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Platinum-resistant Ovarian Cancer

Interventions

DRUG

Rina-S

Intravenous (IV) infusion

DRUG

Paclitaxel

IV infusion

DRUG

Topotecan

IV infusion

DRUG

Pegylated liposomal doxorubicin (PLD)

IV infusion

DRUG

Gemcitabine

IV infusion

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.

Locations (177)

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Arizona Center for Cancer Care (ACCC) - Biltmore

Scottsdale, Arizona, United States

University of Arizona Cancer Center - Research and Administration at Main Campus

Tucson, Arizona, United States

Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center

Burbank, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

USCF Mission Bay

San Francisco, California, United States

Kaiser Permanente - Vallejo Medical Center

Vallejo, California, United States

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

SCRI - Florida Cancer Specialists - South Region Research Office

Fort Myers, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Orlando Health Cancer Institute - Downtown Orlando

Orlando, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

SCRI - Florida Cancer Specialists - West Palm Beach

West Palm Beach, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Northside Hospital Atlanta

Atlanta, Georgia, United States

Augusta University Georgia Cancer Center

Augusta, Georgia, United States

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Northwest Cancer Center - Dyer

Dyer, Indiana, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

HCA Midwest Health

Overland Park, Kansas, United States

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Louisiana State University Health Sciences Center (LSU Health) - New Orleans

New Orleans, Louisiana, United States

Trials365, LLC (Gynecologic Oncology Associates-Shreveport)

Shreveport, Louisiana, United States

Maine Medical Center Cancer Institute- Scarborough

Scarborough, Maine, United States

Holy Cross Health - Holy Cross Hospital

Silver Spring, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Corewell Health (Spectrum Health)

Grand Rapids, Michigan, United States

Saint Joseph Mercy Ann Arbor Hospital

Ypsilanti, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Center of Hope

Reno, Nevada, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Perlmutter Cancer Center - 38th Street

New York, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

New York-Presbyterian - Weill Cornell Medical Center

New York, New York, United States

James P. Wilmot Cancer Center

Rochester, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

JamesCare Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States

Legacy Good Samaritan Medical Center

Portland, Oregon, United States

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

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny Health Network - West Penn Hospital

Pittsburgh, Pennsylvania, United States

Jefferson Health - Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

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

Abilene, Texas, United States

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

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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

Fort Worth, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

USOR - Virginia Oncology Associates - Norfolk

Norfolk, Virginia, United States

Kadlec Clinic - Hematology and Oncology

Kennewick, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Newcastle Private Hospital

New Lambton Heights, New South Wales, Australia

Icon Cancer Centre

South Brisbane, Queensland (qld), Australia

Mater Misericordiae - Mater Hospital Brisbane

South Brisbane, Australia

Saint John of God - Subiaco Hospital

Subiaco, Australia

Krankenhaus Hietzing

Vienna, State of Vienna, Austria

Medizinische Universität Innsbruck

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria (Oberösterreich), Austria

Medizinische Universität Graz

Graz, Austria

Medizinische Universität Wien

Vienna, Austria

Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth

Turnhout, Antwerp, Belgium

AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst

Aalst, Belgium

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

Grand Hôpital de Charleroi - Site Les Viviers

Charleroi, Belgium

Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Chretien - Clinique MontLégia

Liège, Belgium

Algemeen Ziekenhuis Delta - Campus Rumbeke

Roeselare, Belgium

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Sunnybrook Health Sciences Centre - Bayview Campus

Toronto, Canada

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The First Hospital of Jilin University

Changchun, China

Zhejiang Cancer Hospital

Hanzhou, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Henan Cancer Hospital - Zhengzhou University

Zhengzhou, China

University Hospital Královské Vinohrady

Prague, Prague, Czechia

Masaryk Memorial Cancer Institute

Brno, Czechia

And 77 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (177)