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RecruitingLast updated: 10 July 2026

RAINFOL-03: Comparing a targeted drug called Rina-S compared to standard chemotherapy for recurrent or progressive endometrial cancerA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

RAINFOL-03

Clinical summary

Summary

The purpose of this study is to compare how well a targeted drug called Rina-S works compared to standard treatments for people with recurrent or progressive endometrial cancer.

Who can take part?
You may be eligible if you have:

  • recurrent or progressive endometrial cancer following prior treatment
  • received at least 1, but no more than 3, prior lines of treatment
  • prior treatment must have included platinum-based chemotherapy and a PD(L)-1 inhibitor (either separately or in combination)

Eligible participants will be randomly assigned (by chance) to receive either:

  • Rina-S (also known as GEN1184), or
  • Standard treatment with a doctor's choice of chemotherapy (either paclitaxel or doxorubicin)

The study will last for 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 an active drug; no one will be given a placebo. Participation in the study will require visits to the study site(s).

Conditions

This trial is treating people with endometrial cancer

Eligibility

Inclusion

  • 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

Exclusion

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT07166094 *
  • GCT1184-03; JRCT2031250494; MOH_2026-03-29_015739; 2024-519818-31; GOG-3128; ENGOT-EN31; GEICO-158-E

Trial sponsor

Genmab

Scientific Title

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

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