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NCT03100006: ORION-01
Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
Phase 1, PHASE2 trial testing Nivolumab in Epithelial Ovarian Cancer in 13 participants. Terminated before completion.
7 June 2019
Quick facts
| Lead sponsor | National Cancer Centre, Singapore |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 22 February 2017 |
| Primary completion | 7 June 2019 |
| Estimated completion | 17 April 2020 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
- Oregovomab — full drug profile →
Conditions studied
- Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
Sponsor
National Cancer Centre, Singapore
Who can join
Adults 21 to 99, female only, with Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to characterize the safety and tolerability, identify a recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics, and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in ovarian cancer therapy.
Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. · · 2018 · cited 417× · PMID 29249039 · DOI 10.1007/s00280-017-3501-8 -
Immunotherapy for Ovarian Cancer: Adjuvant, Combination, and Neoadjuvant.
Yang C, Xia BR, Zhang ZC, Zhang YJ, et al · · 2020 · cited 246× · PMID 33123161 · DOI 10.3389/fimmu.2020.577869 -
Recent Insights into PARP and Immuno-Checkpoint Inhibitors in Epithelial Ovarian Cancer.
Revythis A, Limbu A, Mikropoulos C, Ghose A, et al · · 2022 · cited 73× · PMID 35886427 · DOI 10.3390/ijerph19148577 -
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 -
Role of tumor microenvironment in ovarian cancer pathobiology.
Ghoneum A, Afify H, Salih Z, Kelly M, et al · · 2018 · cited 58× · PMID 29854318 · DOI 10.18632/oncotarget.25126 -
Exploring the clinical value of tumor microenvironment in platinum-resistant ovarian cancer.
Ghoneum A, Almousa S, Warren B, Abdulfattah AY, et al · · 2021 · cited 53× · PMID 33476723 · DOI 10.1016/j.semcancer.2020.12.024 -
Role of tumor microenvironment in the pathobiology of ovarian cancer: Insights and therapeutic opportunities.
Ghoneum A, Afify H, Salih Z, Kelly M, et al · · 2018 · cited 46× · PMID 30133163 · DOI 10.1002/cam4.1741 -
Development of Therapeutic Vaccines for Ovarian Cancer.
Chow S, Berek JS, Dorigo O. · · 2020 · cited 28× · PMID 33167428 · DOI 10.3390/vaccines8040657
Verify or expand the search:
- PubMed search for NCT03100006
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Epithelial Ovarian Cancer
Currently open trials in the same condition.
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Trials by the same sponsor.
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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 NCT03100006 (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 Centre, Singapore
- Last refreshed: 13 June 2022
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/NCT03100006.
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