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

Last updated: May 5, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cysts

Treatment

Gemcitabine

Paclitaxel

Pegylated liposomal doxorubicin (PLD)

Clinical Study ID

NCT06619236
GCT1184-02
RAINFOL-OV2
PRO1184-002
2024-514822-21
GOG-3107
ENGOT-OV86
  • Ages > 18
  • Female

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 Criteria

Inclusion

Key Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed high grade serousor endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopiantube 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 standardof care per institutional guidelines, unless the participant has a documentedcontraindication or due to precautions/intolerance

  • Participants with known or suspected deleterious germline or somatic breastcancer gene (BRCA) mutations and who achieved a complete or partial response toplatinum-based chemotherapy must have been treated with a poly ADP-ribosepolymerase (PARP) inhibitor as maintenance treatment unless the participant isnot 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 andDrug Administration (FDA)-approved (or local equivalent) test, and

  • The participant does not have a documented medical exception, includingchronic corneal disorders, history of corneal transplantation, or activeocular conditions requiring ongoing treatment/monitoring, such asuncontrolled glaucoma, wet age-related macular degeneration requiringintravitreal 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 havereceived at least 4 cycles of platinum therapy, and must have either had aresponse (CR or PR) or had non-measurable disease at the start ofplatinum-based therapy, and then progressed between > 91 days and ≤ 183 daysafter the date of the last dose of platinum.

  • Participants who have received 2 to 4 lines of platinum-based therapy must haveprogressed on or within 183 days after the date of the last dose of platinum.

Exclusion

Key Exclusion Criteria:

  • Prior therapy with an antibody-drug conjugate containing a topoisomerase 1inhibitor.

  • Have primary platinum-refractory disease, defined as ovarian cancer that did notrespond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-lineplatinum-containing regimen.

  • History of another malignancy within 3 years before the first dose of study drug, orany evidence of residual disease from a previously diagnosed malignancy. Exceptionsare 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 thecervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterinecancer.

  • Known active central nervous system metastases or carcinomatous meningitis.Participants with previously treated brain metastases may participate provided theyare clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment, they have no new or enlarging brain metastases, and are offcorticosteroids and anticonvulsants prescribed for symptoms associated with brainmetastases for at least 7 days prior to the first dose of study drug. Participantswith 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 thepast 91 days or radiographic evidence of gastrointestinal obstruction at the time ofscreening. Enrollment of participants who currently require parenteral nutritionmust be discussed with the study medical monitor to determine eligibility.

  • Ascites requiring frequent paracentesis (more often than approximately every 4weeks) for symptomatic management. Enrollment of participants with an indwellingperitoneal catheter must be discussed with the medical monitor to determineeligibility.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 530
Treatment Group(s): 5
Primary Treatment: Gemcitabine
Phase: 3
Study Start date:
February 07, 2025
Estimated Completion Date:
April 05, 2028

Connect with a study center

  • University of California San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • USCF Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut 06850
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute - Downtown Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • St. Elizabeth Healthcare - Edgewood

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Trials365, LLC

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Trials365, LLC (Gynecologic Oncology Associates-Shreveport)

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Center of Hope

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • Perlmutter Cancer Center - 38th Street

    New York, New York 10016
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    New York, New York 10016
    United States

    Active - Recruiting

  • Duke Cancer Institute

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina 28374
    United States

    Active - Recruiting

  • JamesCare Gynecologic Oncology at Mill Run

    Hilliard, Ohio 43026
    United States

    Active - Recruiting

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

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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

    Abilene, Texas 79606
    United States

    Active - Recruiting

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

    Austin, Texas 78731
    United States

    Active - Recruiting

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

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • USOR - Virginia Oncology Associates - Norfolk

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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