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NCT06121401: IOLANTHE
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
Phase 4 trial testing Olaparib in Carcinoma, Ovarian Epithelial in 190 participants. Participants enrolled and being followed up; not accepting new ones.
15 March 2027
Quick facts
| Lead sponsor | Mario Negri Institute for Pharmacological Research |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 190 |
| Start date | 15 September 2023 |
| Primary completion | 15 March 2027 |
| Estimated completion | 15 September 2027 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Olaparib (olaparib) — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Carcinoma, Ovarian Epithelial — all drugs for Carcinoma, Ovarian Epithelial →
Sponsor
Mario Negri Institute for Pharmacological Research
Who can join
Adults 18 to 75, female only, with Carcinoma, Ovarian Epithelial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
HR-SC-an academic-developed machine learning framework to classify HRD-positive ovarian cancer patients and predict sensitivity to olaparib.
Beltrame L, Mannarino L, Sergi A, Velle A, et al · · 2025 · cited 3× · PMID 40393377 · DOI 10.1016/j.esmoop.2025.105060 -
Opportunities for predictive proteogenomic biomarkers of drug treatment sensitivity in epithelial ovarian cancer.
Philips TJ, Erickson BK, Thomas SN. · · 2024 · cited 1× · PMID 39839766 · DOI 10.3389/fonc.2024.1503107 -
Targeting Tumor Stroma: Current Challenges and Future Directions.
Wang S, Hu H, Zeng W, Qin L, et al · · 2026 · PMID 42125068 · DOI 10.1002/mco2.70763 -
Multimodal tumor-agnostic ctDNA analysis for minimal residual disease detection and risk stratification in ovarian cancer: results from the MITO16a/MaNGO-OV2 trial.
Paracchini L, Velle A, Di Gennaro P, Mannarino L, et al · · 2026 · PMID 41747586 · DOI 10.1016/j.esmoop.2026.106087
Verify or expand the search:
- PubMed search for NCT06121401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Carcinoma, Ovarian Epithelial
Currently open trials in the same condition.
- NCT05544929 — A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers · Phase 1 · active not recruiting
- NCT05601700 — Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) · Phase 3 · recruiting
- NCT05116189 — Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-34 · Phase 3 · active not recruiting
- NCT04807166 — Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer · Phase 2 · active not recruiting
- NCT04660929 — CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting
Other Mario Negri Institute for Pharmacological Research trials
Trials by the same sponsor.
- NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
- NCT07331103 — RESOLving INflammation Through Diet for Health (RESOLVIN) · NA · recruiting
- NCT06994468 — Effect of B-cell Depleting Therapies on PLA2R-specific B Cells in Patients With Membranous Nephropathy · NA · completed
- NCT07111624 — A New Crowding Indicator in the Emergency Department · not yet recruiting
- NCT07021118 — Mild TBI in the Emergency Department · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06121401 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mario Negri Institute for Pharmacological Research
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06121401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing