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

Primary Purpose

Ovarian Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OncoImmunome

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UConn Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OncoImmunome/Vaccine Phase

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

1) Measurement of CD8 T cell proliferation and T cell phenotype in response to the Oncoimmunome peptides in immunized subjects

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

Progression-free survival of patients immunized with Oncoimmunome.

Full Information

NCT ID

NCT02933073

First Posted

September 20, 2016

Last Updated

November 1, 2022

Sponsor

UConn Health

1. Study Identification

Unique Protocol Identification Number

NCT02933073

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Study recruitment is temporary on hold by the sponsor due to patient recruitment challenges and the ongoing review of the investigational adjuvant.

Study Start Date

November 2016 (undefined)

Primary Completion Date

August 2022 (Actual)

Study Completion Date

August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UConn Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The study will be conducted under an IRB approval, in accordance with FDA regulations and Human Subject Protection regulations. Female patients will undergo standard of care therapy to include exploratory laparotomy and cytoreduction (debulking) surgery followed by chemotherapy. Only patients with histological confirmation of FIGO Stage III/IV epithelial adenocarcinoma of ovarian, tubal or peritoneal origin will be screened and enrolled into the study. At cytoreduction surgery a portion of the surgically resected tumor is preserved for vaccine production. The surgically resected tumor as well as normal cells obtained from peripheral blood shall be used for extraction of RNA and DNA sequencing of the tumor and normal transcriptomes, as well as normal exome sequencing, in the Genomic Core Facility at UConn Health. Patient's blood cells shall also be HLA typed. When the patient has recovered from surgery, standard of care chemotherapy is given. Following completion of standard chemotherapy (6-8 cycles) and Investigator's confirmation of clinical remission, patients will be consented as subjects for the experimental investigative portion of the study. The overall purpose of this research study is to produce and test the safety of a new experimental vaccine called OncoImmunome in people with Stage III/IV Ovarian Cancer. An "experimental vaccine" is a vaccine that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The study has been divided into two parts: 1)Tumor Tissue and Blood Sample Collection and 2) Vaccine and Follow-up. Study participants will consent to the following: Tumor Tissue and Blood Sample Collection: The purpose of this part of the study is to collect participants' blood and tumor tissue and test it for genetic mutations. These test results will be used to manufacture a study vaccine that is unique to the participant and to their ovarian cancer. Vaccine and Follow-up: The purpose of this part of the study is to test the safety of the experimental drug (vaccine) called OncoImmunome, which has been produced specifically for each participant. Subject participation in this research study will last up to 5 years. The vaccine will be produced over a 6 month period, and for six months subjects will receive the study vaccine (1 study vaccine dose per month or 6 study vaccine doses total). However, the researchers will continue to collect all subjects information for up 5 years from the time they provided their tumor sample and blood for the research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OncoImmunome/Vaccine Phase

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

OncoImmunome

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

Description

1) Measurement of CD8 T cell proliferation and T cell phenotype in response to the Oncoimmunome peptides in immunized subjects

Time Frame

5 years

Title

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

Description

Progression-free survival of patients immunized with Oncoimmunome.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Tannenbaum, MD

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

UConn Health

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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