Study to assess the efficacy and safety of Rina-S plus standard of care compared to standard of care for maintenance treatment of participants with recurrent platinum-sensitive ovarian cancer after second-line (2-L) platinum-based doublet chemotherapy (RAINFOL-04)

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)

2026-07-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genmab A/S

External identifiers

EU CT number

2025-522167-15-00

ClinicalTrials.gov

NCT07225270

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Therapy, Efficacy

To compare progression-free survival (PFS) of RinaS+standard of care (SOC) vs SOC as maintenance treatment after 2L platinum-based doublet chemotherapy in participants with recurrent platinum-sensitive ovarian cancer

Secondary objectives 3

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

Conditions and MedDRA coding

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
2. 2. Must have PSOC defined as progressive disease > 6 months (ie, >183 days) from the last dose of primary (1L) platinum therapy.
3. 3. Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
4. 4. Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
5. 5. Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
6. 6. Participants must have achieved a CR/NED, PR, or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.

Exclusion criteria 4

1. 1. Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors
2. 2. More than 2 prior lines of systemic therapy.
3. 3. Progression while on or following 2L platinum-based regimen prior to randomization.
4. 4. Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. PFS per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as determined by blinded independent central review (BICR)

Secondary endpoints 2

1. 1. Overall survival (OS) PFS, per RECIST 1.1, as determined by investigator assessment; Second determination of PFS (PFS2) Treatment-emergent adverse events
2. 2. Overall change from baseline in Global Health Status/Quality of Life (GHS/Qol) Score using the EORTC QLQ-C30 questionnaire Time to deterioration (TTD) in the GHS/Qol Scousing the EORTC QLQ-C30 questionnaire

Investigational products

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

Test 1

Comparator 1

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 7

Locations

10 EU/EEA countries · 81 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 81 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