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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

Terminated Phase 1, PHASE2 Last updated 13 June 2022
What this trial tests

Phase 1, PHASE2 trial testing Nivolumab in Epithelial Ovarian Cancer in 13 participants. Terminated before completion.

Timeline
22 February 2017
Primary endpoint
7 June 2019
17 April 2020

Quick facts

Lead sponsorNational Cancer Centre, Singapore
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date22 February 2017
Primary completion7 June 2019
Estimated completion17 April 2020
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for Epithelial Ovarian Cancer

Currently open trials in the same condition.

Other National Cancer Centre, Singapore trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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