Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator’s Choice in Participants With Endometrial Cancer ( RAINFOL-03 )

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genmab A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Genmab A/S

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To compare clinical efficacy of Rina-S to treatment of investigator’s choice (IC) in patients with recurrent or progressive endometrial cancer (EC) following prior therapy

Secondary objectives 3

1. To assess additional measures of efficacy of Rina-S compared to IC
2. To assess the safety of Rina-S compared to IC
3. To assess patient-reported outcomes (PROs) in patients receiving Rina-S and IC

Conditions and MedDRA coding

Endometrial Cancer Advanced, Recurrent, Metastatic, or Primary Unresectable Endometrial Cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 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.
2. Participants must have received at least 1, but not more than 3, prior lines of therapy:
3. Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
4. 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 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.
5. Prior induction plus maintenance is considered 1 line of therapy
6. Hormonal therapy alone (ie, without chemotherapy) will not be counted as a separate line of therapy.
7. 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)
8. Participants must have progressed radiographically on or after their most recent line of therapy

Exclusion criteria 4

1. Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
2. 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 (eg, 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 (ie, eligible participants must have complete response of ≥3 years duration).
3. 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.
4. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years]
2. 2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]

Secondary endpoints 8

1. Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC
2. PFS, per RECIST v1.1, as determined by investigator assessment
3. ORR, per RECIST v1.1, as Determined by investigator assessment
4. Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment
5. DOR, per RECIST v1.1, as Determined by BICR
6. Number of Participants with Treatment-emergent Adverse Events (TEAEs)
7. Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)
8. Time to Deterioration (TTD) in GHS/Qol

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genmab A/S

Sponsor organisation

Genmab A/S

Address

Carl Jacobsens Vej 30

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

Genmab A/S

Contact name

Genmab Trial Information

Public contact point

Organisation

Genmab A/S

Contact name

Genmab Trial Information

Third parties 12

Locations

11 EU/EEA countries · 80 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 98 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications