Rina-S versus standard chemotherapy for recurrent or progressive endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, open-label Phase 3 randomized study will enroll about 660 participants with recurrent or progressive endometrial cancer who have had 1–3 prior lines of therapy. Participants are randomized 1:1 to receive Rina-S or the investigator's choice of paclitaxel or doxorubicin, with investigators preselecting the chemotherapy option before randomization. The study requires regular in-person visits and all participants receive active treatment (no placebo), with average treatment lasting about 4–6 months and the overall study expected to run approximately 3 years. Key eligibility includes prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy, and certain histologic subtypes (neuroendocrine tumors, carcinosarcoma, endometrial sarcoma) are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• USAH Mitchell Cancer Inst
  Mobile, Alabama, United States Recruiting
• HonorHealth Research Inst
  Phoenix, Arizona, United States Recruiting
• Kaiser Permanente SoCal
  Irvine, California, United States Recruiting
• CPMC Research Institute
  San Francisco, California, United States Recruiting
• Norwalk Hospital
  Danbury, Connecticut, United States Recruiting
• Hartford Hospital
  Hartford, Connecticut, United States Recruiting

+128 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.