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NCT04417192: OLAPem
Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer
Phase 2 trial testing Olaparib in Ovarian Cancer in 30 participants. Completed in 30 June 2023.
30 June 2023
Quick facts
| Lead sponsor | National Cancer Center Hospital East |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2020 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 3 locations across Japan |
Drugs / interventions tested
- Olaparib (olaparib) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
National Cancer Center Hospital East
Who can join
20 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and safety of preoperative olaparib monotherapy and preoperative olaparib plus pembrolizumab combination therapy in patients with untreated stage III, IV high-grade serous or Grade 3 endometrioid ovarian cancer with Homologous Recombination Deficiency (HRD) positivity.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0 -
Ovarian Cancer in the Era of Immune Checkpoint Inhibitors: State of the Art and Future Perspectives.
Maiorano BA, Maiorano MFP, Lorusso D, Maiello E. · · 2021 · cited 60× · PMID 34503248 · DOI 10.3390/cancers13174438 -
Current Understanding on Why Ovarian Cancer Is Resistant to Immune Checkpoint Inhibitors.
Pawłowska A, Rekowska A, Kuryło W, Pańczyszyn A, et al · · 2023 · cited 41× · PMID 37446039 · DOI 10.3390/ijms241310859 -
Combining PARP inhibition and immune checkpoint blockade in ovarian cancer patients: a new perspective on the horizon?
Musacchio L, Cicala CM, Camarda F, Ghizzoni V, et al · · 2022 · cited 37× · PMID 35849879 · DOI 10.1016/j.esmoop.2022.100536 -
The Interplay between PARP Inhibitors and Immunotherapy in Ovarian Cancer: The Rationale behind a New Combination Therapy.
Maiorano BA, Lorusso D, Maiorano MFP, Ciardiello D, et al · · 2022 · cited 28× · PMID 35409229 · DOI 10.3390/ijms23073871 -
Efficacy evaluation of multi-immunotherapy in ovarian cancer: From bench to bed.
Hu X, Bian C, Zhao X, Yi T. · · 2022 · cited 19× · PMID 36275669 · DOI 10.3389/fimmu.2022.1034903 -
Application of PARP inhibitors combined with immune checkpoint inhibitors in ovarian cancer.
Xiao F, Wang Z, Qiao L, Zhang X, et al · · 2024 · cited 18× · PMID 39169400 · DOI 10.1186/s12967-024-05583-z -
Towards Personalized Management of Ovarian Cancer.
Algethami M, Kulkarni S, Sadiq MT, Tang HKC, et al · · 2022 · cited 10× · PMID 36545222 · DOI 10.2147/cmar.s366681
Verify or expand the search:
- PubMed search for NCT04417192
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
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- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
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Other National Cancer Center Hospital East trials
Trials by the same sponsor.
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- NCT05646511 — TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT05394740 — Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy · Phase 1, PHASE2 · completed
- NCT05034887 — Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus D · Phase 2 · active not 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 NCT04417192 (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 National Cancer Center Hospital East
- Last refreshed: 6 July 2023
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/NCT04417192.
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