Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma

NCT02933073 | Terminated Phase 1 DMC

• 1 other identifier: Q16-158-3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Monitoring of treatment-related adverse events as assessed by CTCAE v4.0 in subjects immunized with Oncoimmunome

  Number of Participants with Oncoimmunome Immunization related Adverse Events (AE) as assessed by CTCAE v. 4.03.

  5 years

Secondary Outcomes (2)

• Monitoring of subjects immunized with Oncoimmunome for immune response to components of Oncoimmunome

  5 years

• Monitoring of subjects immunized with Oncoimmunome for progression-free survival.

  5 years

Study Arms (1)

OncoImmunome/Vaccine Phase

EXPERIMENTAL

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.

Biological: OncoImmunome

Interventions

OncoImmunome BIOLOGICAL

The OncoImmunome will be a substance composed of a mixture of seven to ten peptides each containing 17-18 amino acids. Given that the vaccine will be tumor-specific based upon mutant peptide sequences identified in each tumor transcriptome, the vaccine for each patient will likely be a unique composition.

OncoImmunome/Vaccine Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patient must have completed standard platinum based adjuvant chemotherapy as per standard-of-care (only applicable for Vaccine Phase).
• Patients must have a life expectancy of at least 6 months.
• 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.
• Patients with Patients with ECOG/WHO/Zubrod scale performance status \< or = 2.
• No evidence of active infection.
• 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.
• Patients not participating in another experimental program/therapy at least 4 weeks prior to enrollment.
• 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.
• Patients must be English speaking and sign an approved informed consent form (ICF) and HIPAA.

You may not qualify if:

• Patient not enrolled in the UConn Health Center Research Tissue Registry/Repository (Biorepository) study or there is inadequate tissue available for this study.
• Patients not in clinical remission after standard chemotherapy.
• Patients with recurrent Stage III/IV epithelial ovarian/tubal/peritoneal carcinoma with first recurrence \< 12 months after initial therapy.
• Patients who have active autoimmune disease.
• Patients with any medical condition that would interfere with their ability to complete the study.
• Patients who are receiving any experimental drug therapy within 4 weeks of enrollment.
• Patients who are taking steroids (excludes topical steroids) within 4 weeks of enrollment.
• 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).
• Patients unable or unwilling to provide informed consent.
• Patients whose tumors are not able to be sequenced or from which sufficient suitable neo- epitopes are not able to be identified.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06032, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Susan Tannenbaum, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)