Trial · NCT04498117
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
NCT04498117, Phase 3, Active not recruiting, CanariaBio Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery. Trials, record NCT04498117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04498117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
- NCT number
- NCT04498117
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 615 participants, actual
- Lead sponsor
- CanariaBio Inc.
- Conditions
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Peritoneal Cancer, Peritoneal Carcinoma, Peritoneal Neoplasms
- Interventions
- Oregovomab, Paclitaxel, Carboplatin, Placebo, Carboplatin
- First posted
- 2020-08-04
- Last updated
- 2026-04-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator Assessed Progression Free Survival | Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 6 years. | Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death |
| Secondary | Overall Survival | Date of randomization up until date of death from any cause, up to approximately 11 years | Date of randomization to the date of death |
| Secondary | Safety and Tolerability | Date of randomization up until date of discontinuation of treatment, date of significant physical examination changes, date of significant clinical changes, up to approximately 6 years | Incidence of adverse events (AEs) leading to discontinuation of treatment, frequency/severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters |
| Secondary | Change in Quality of Life | Changes from baseline assessment, until date of discontinuation, or up to approximately 6 years | 1. Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O TOI) 2. Three additional questions from the NFOSI-18 in each treatment group |
| Other | Efficacy by times to subsequent therapies and time to next progression | Date of randomization, until date of subsequent therapy or death, or up to approximately 6 years | 1. Tumor response measurement by iRECIST 2. Time to First Subsequent Therapy (TFST), defined as tie form the date of randomization to first subsequent anti-cancer therapy or death 3. Time to Second Subsequent Therapy, defined as time from the date of randomization to second anti-cancer therapy start date or death 4. Progression Free Survival 2, defined from the date of randomization to the first documented progression on next-line therapy or death. |
| Other | Potential Biomarkers | Date of randomization, until date of discontinuation, or up to approximately 6 years | 1. Human Anti-Mouse Antibody (HAMA) 2. HAMA interference-free CA-125 3. Neutrophil + Monocyte to Lymphocyte Ratio (NMLR) 4. Phenotyping or immune subsets, including myeloid-derived suppressor cells (MDSC) 5. Functional assessment of CD4+ and CD8+ T-cells with a focus on measuring the number and frequency of INF-y-producing CD8+ T-cells using flow cytometry |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04498117
GET https://conductscience.org/api/trials/v1/NCT04498117/registered