Clinical trial · Interventional
Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma
A Phase I Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study recruitment is temporary on hold by the sponsor due to patient recruitment challenges and the ongoing review of the investigational adjuvant.
Summary
Brief summary (as posted)
This is a Phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which is predicted to elicit tumor-protective immune responses. A total of 15 patients will be enrolled from the Principal Investigator (PI) clinical practice. These patients will have just successfully completed standard of care surgical debulking with preservation of fresh tumor, chemotherapy treatment and be in documented clinical remission prior to receiving the vaccine. The patients receive 6-monthly doses of the vaccine and are monitored for up to 5 years post vaccination. This is a personalized vaccine, unique to each patient and is the "first in human" use.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoImmunome | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OncoImmunome/Vaccine Phase
- description
- Women with Stage III/IV Ovarian Cancer who have received the standard of care treatment (surgical debulking and chemotherapy) for their cancer and are now in clinical remission will be given the experimental drug (vaccine) called OncoImmunome, which has been produced specifically for each participant.
- interventionNames
- Biological: OncoImmunome
Primary outcomes (1)
- measure
- Monitoring of treatment-related adverse events as assessed by CTCAE v4.0 in subjects immunized with Oncoimmunome
- timeFrame
- 5 years
- description
- Number of Participants with Oncoimmunome Immunization related Adverse Events (AE) as assessed by CTCAE v. 4.03.
Secondary outcomes (2)
- measure
- Monitoring of subjects immunized with Oncoimmunome for immune response to components of Oncoimmunome
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients \>18 years of age must have a diagnosis of histologically confirmed Stage III/IV epithelial ovarian/fallopian tube/primary peritoneal adenocarcinoma who have not received any treatment or patients with recurrent Stage III/IV epithelial ovarian/tubal/peritoneal carcinoma with first recurrence ≥12 months after initial therapy and with resectable disease. 2. All patients must have cytoreduction/laparoscopic surgery at UConn Health and their tissue must be stored in the UConn Health Center Research Tissue Registry/Repository (Biorepository) using cryopreservation methods. 3. Patient must have completed standard platinum based adjuvant chemotherapy as per standard-of-care (only applicable for Vaccine Phase). 4. Patients must have a life expectancy of at least 6 months. 5. In the clinical judgment of the investigator, patients must have adequate renal, hepatic, and bone marrow function to complete the study: * Hematologic function: Absolute neutrophil count (ANC) must be greater than 1000 per mcl. White blood count equal to or greater than 3000 per mcl, platelet count greater than or equal to 100,000 per mcl. * Renal function: Serum creatinine equal to or less than 2.0 mg/dl. * Hepatic function: Bilirubin \<1.5 x institutional normal. 6. Patients with Patients with ECOG/WHO/Zubrod scale performance status \< or = 2. 7. No evidence of active infection. 8. No evidence of active infection requiring systemic therapy. Patients enrolled in the Tissue and Blood Phase may receive IV antibiotics preoperatively, IV in surgery when they have a Hysterectomy and also postoperatively. 9. Patients not participating in another experimental program/therapy at least 4 weeks prior to enrollment. 10. Patients have enrolled and have adequate cancer tissue sample available from this cytoreduction/laparoscopic surgery deposited in the UConn Health Center Research Tissue Registry/Repository (Biorepository) study (Principal Investigator: Mary Melinda Sanders, MD; UConn Health IRB# 08-310-1) for this study. 11. Patients must be English speaking and sign an approved informed consent form (ICF) and HIPAA. Exclusion Criteria: 1. Patient not enrolled in the UConn Health Center Research Tissue Registry/Repository (Biorepository) study or there is inadequate tissue available for this study. 2. Patients not in clinical remission after standard chemotherapy. 3. Patients with recurrent Stage III/IV epithelial ovarian/tubal/peritoneal carcinoma with first recurrence \< 12 months after initial therapy. 4. Patients who have active autoimmune disease. 5. Patients with any medical condition that would interfere with their ability to complete the study. 6. Patients who are receiving any experimental drug therapy within 4 weeks of enrollment. 7. Patients who are taking steroids (excludes topical steroids) within 4 weeks of enrollment. 8. Patients with a prior malignancy within the previous 5 years or a synchronous primary cancer (non-melanoma skin cancer or other In Situ cancers are excluded). 9. Patients unable or unwilling to provide informed consent. 10. Patients whose tumors are not able to be sequenced or from which sufficient suitable neo- epitopes are not able to be identified.
References
Publications (0)
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