Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 3

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

NCT ID: NCT07166094Sponsor: GenmabLast updated: 2026-06-02

Summary

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

Detailed description

This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.

Arms & interventions

  • DrugRina-S

    Intravenous (IV) infusion.

  • DrugIC

    * Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

Outcome measures

Primary

  • Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)

    Time frame: Up to approximately 3 years

  • Overall Survival (OS)

    Time frame: Up to approximately 3 years

Secondary

  • Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR

    Time frame: Up to approximately 3 years

  • PFS, per RECIST v1.1, as Determined by Investigator Assessment

    Time frame: Up to approximately 3 years

  • ORR, per RECIST v1.1, as Determined by Investigator Assessment

    Time frame: Up to approximately 3 years

  • Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment

    Time frame: Up to approximately 3 years

  • DOR, per RECIST v1.1, as Determined by BICR

    Time frame: Up to approximately 3 years

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 3 years

  • Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)

    Time frame: Baseline up to approximately 3 years

  • Time to Deterioration (TTD) in GHS/Qol

    Time frame: Up to approximately 3 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria * Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy. * Participants must have received at least 1, but not more than 3, prior lines of therapy: * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented. * Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented. * Prior induction plus maintenance is considered 1 line of therapy * Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy. * Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy) * Participants must have progressed radiographically on or after their most recent line of therapy Key Exclusion Criteria * Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. * Has a past or current malignancy other than the inclusion diagnosis before the planned 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 cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration). * 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 completion of 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 planned 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 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. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study locations (43)

MedStar Washington Hospital

Washington D.C., District of Columbia, 20010

Recruiting

SMH - Sarasota - Main Campus

Sarasota, Florida, 34239

Recruiting

Women's Care - 9th Ave

St. Petersburg, Florida, 33713

Recruiting

Emory Winship Cancer Inst.

Atlanta, Georgia, 30308

Recruiting

Emory Winship Cancer Inst.

Atlanta, Georgia, 30322

Recruiting

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia, 30033

Recruiting

Trials365, LLC

Shreveport, Louisiana, 71103

Recruiting

Sinai Hospital

Baltimore, Maryland, 21215

Recruiting

William Kahlert Reg. Can. Ctr

Westminster, Maryland, 21157

Recruiting

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota, 55433

Recruiting

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota, 55433

Recruiting

USOR - Minnesota Oncology - Edina Clinic

Edina, Minnesota, 55435

Recruiting

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota, 55435

Recruiting

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota, 55369

Recruiting

USOR - Minnesota Oncology-Maplewood Clinic

Maplewood, Minnesota, 55109

Recruiting

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota, 55109

Recruiting

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, 55404

Recruiting

USOR - Minnesota Oncology

Minneapolis, Minnesota, 55404

Recruiting

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, 55125

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

Recruiting

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401

Recruiting

NW Cancer Specs. P.C.

Happy Valley, Oregon, 97015

Recruiting

USOR - NW Cancer Specs P.C.

Portland, Oregon, 97227

Recruiting

USOR - NW Cancer Specs. P.C.

Tigard, Oregon, 97223

Recruiting

TX Onc - Arlington North

Arlington, Texas, 76012

Recruiting

USOR - Texas Oncology

Austin, Texas, 78731

Recruiting

USOR - Texas Oncology

Austin, Texas, 78745

Recruiting

USOR - Texas Oncology- Austin North

Austin, Texas, 78758

Recruiting

TX Onc - Bedford

Bedford, Texas, 76022

Recruiting

TX Onc - Methodist Dallas

Dallas, Texas, 75203

Recruiting

TX Onc - Presbyterian Dallas

Dallas, Texas, 75231

Recruiting

TX Onc - Methodist Charlton

Dallas, Texas, 75237

Recruiting

TX Onc - Sammons

Dallas, Texas, 75246

Recruiting

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas, 76104

Recruiting

USOR - Texas Oncology

Harlingen, Texas, 78550

Recruiting

USOR - Texas Oncology

McAllen, Texas, 78503

Recruiting

USOR - TX Oncology - SA NE

San Antonio, Texas, 78217

Recruiting

NEXT San Antonio

San Antonio, Texas, 78240

Recruiting

USOR - Texas Oncology- Horizon Circle

Waco, Texas, 76712

Recruiting

USOR - Texas Oncology- Waco

Waco, Texas, 76712

Recruiting

USOR - Texas Oncology

Weslaco, Texas, 78596

Recruiting

USOR - NW Cancer Specs P.C.

Vancouver, Washington, 98684

Recruiting