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A Trial Evaluating TG4050 in Ovarian Carcinoma.

Primary Purpose

Ovarian Carcinoma, Fallopian Tube Cancer, Peritoneal Carcinoma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

TG4050

About this trial

This is an interventional treatment trial for Ovarian Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Signed written informed consent.
Female patients ≥ 18 years
Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked.
Patients must have achieved a complete response to therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation
Adequate hematological, hepatic and renal functions.

Exclusion Criteria:

Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4)
Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
Major surgery within 4 weeks of treatment start.
Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
Uncontrolled intercurrent illness.

Sites / Locations

Mayo Clinic PhoenixRecruiting
Mayo Clinic JacksonvilleRecruiting
Mayo Clinic RochesterRecruiting
Institut CurieRecruiting
Hôpital Pitié-SalpêtrièreRecruiting
IUCT ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TG4050 arm

Arm Description

Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.

Outcomes

Primary Outcome Measures

Safety and tolerability (Adverse Event reported per CTCAE v5)

Incidence of Adverse Event reported per CTCAE v5

Secondary Outcome Measures

Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria

Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria.

Best Overall Tumor Response Rate

Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) criteria over the the total number of patients evaluable.

Rate of patients with immune response

Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.

Full Information

NCT ID

NCT03839524

First Posted

February 6, 2019

Last Updated

September 22, 2021

Sponsor

Transgene

1. Study Identification

Unique Protocol Identification Number

NCT03839524

Brief Title

A Trial Evaluating TG4050 in Ovarian Carcinoma.

Official Title

A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2019 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Transgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

6. Conditions and Keywords

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

Ovarian Carcinoma, Fallopian Tube Cancer, Peritoneal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TG4050 arm

Arm Type

Experimental

Arm Description

Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.

Intervention Type

Drug

Intervention Name(s)

TG4050

Intervention Description

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.

Primary Outcome Measure Information:

Title

Safety and tolerability (Adverse Event reported per CTCAE v5)

Description

Incidence of Adverse Event reported per CTCAE v5

Time Frame

At each study visit up to final safety follow up visit: every week for the first 6 weeks and then every 3 weeks

Secondary Outcome Measure Information:

Title

Best overall response rate as assessed by the Gynecological Cancer Intergroup (GCIC) Carbohydrate Antigen 125 (CA-125) criteria

Description

Percentage of patients with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to pre-treatment CA-125 serum level per the GCIC criteria.

Time Frame

Every 3 weeks

Title

Best Overall Tumor Response Rate

Description

Time Frame

Within 21 days of treatment initiation and then every 9 weeks

Title

Rate of patients with immune response

Description

Percentage of patients who achieve an immune response established by the detection of antigen-specific T cell.

Time Frame

Days 64, 85 and 211

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent. Female patients ≥ 18 years Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma. Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked. Patients must have achieved a complete response to therapy Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation Adequate hematological, hepatic and renal functions. Exclusion Criteria: Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4) Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma. Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome). Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV). Major surgery within 4 weeks of treatment start. Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation. Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed. Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration. Uncontrolled intercurrent illness.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Transgene EU, Clinical Operations Department

Phone

+ 33.3.88.27.91.00

clinicaltrials@transgene.fr

Facility Information:

Facility Name

Mayo Clinic Phoenix

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Seetharam

Facility Name

Mayo Clinic Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Colon-Otero

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Block

Facility Name

Institut Curie

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pr Le Tourneau

Facility Name

Hôpital Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pr Spano

Facility Name

IUCT Toulouse

City

Toulouse

ZIP/Postal Code

31100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Martinez

12. IPD Sharing Statement

Learn more about this trial

A Trial Evaluating TG4050 in Ovarian Carcinoma.

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