What is the mechanism of action of this treatment?

Therapeutic vaccines and immunotherapies for ovarian cancer, such as TG4050, work by stimulating the patient's immune system to recognize and attack cancer cells. These treatments often target specific cancer antigens, which are proteins expressed on the surface of cancer cells but not on normal cells. By training the immune system to identify these antigens, the body can more effectively target and destroy cancer cells. This approach is significant for ovarian cancer patients as it offers a personalized treatment option that can potentially improve outcomes and reduce the likelihood of recurrence by harnessing the body's natural defenses.

What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, particularly immunotherapies and therapeutic vaccines like TG4050, often lead to immune-related side effects. These can include fatigue, rash, diarrhea, and pruritus. More severe side effects may involve pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions, as the activated immune system can sometimes target normal tissues.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer include several immunotherapies and targeted therapies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for use in ovarian cancer with specific genetic markers such as high tumor mutational burden or mismatch repair deficiency. Additionally, bevacizumab, an anti-VEGF monoclonal antibody, is approved for use in combination with chemotherapy for advanced ovarian cancer. While there are no FDA-approved therapeutic vaccines specifically for ovarian cancer, investigational treatments like TG4050 are exploring this approach by targeting specific cancer antigens to stimulate the immune system.

What other types of research exist?

Promising novel alternatives to TG4050 for ovarian cancer patients in 2024 include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various cancers including ovarian cancer. 2) Dostarlimab, another PD-1 inhibitor, which has demonstrated activity in mismatch repair-deficient tumors. 3) PARP inhibitors like Olaparib and Niraparib, which are effective in patients with BRCA mutations or homologous recombination deficiency. 4) Bevacizumab, an anti-VEGF antibody, which is used in combination with chemotherapy for advanced ovarian cancer. These treatments offer different mechanisms of action and have shown promise in clinical settings.

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Cancer Vaccine

TG4050 for Ovarian Cancer

Phase 1

Waitlist Available

Research Sponsored by Transgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation

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

Must not have

Uncontrolled intercurrent illness

Major surgery within 4 weeks of treatment start

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 64, 85 and 211

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called TG4050 to see if it is safe and effective for patients with ovarian, fallopian, or peritoneal serous carcinoma. The treatment likely helps the immune system fight cancer cells.

Who is the study for?

This trial is for women over 18 with high-grade serous ovarian, fallopian tube, or peritoneal carcinoma who've had surgery and chemotherapy with a complete response. They must be in good health otherwise, not have other recent cancers or chronic infections like hepatitis or HIV, and can't be on immunosuppressants.

What is being tested?

The trial is testing TG4050, a new potential treatment for certain types of cancer affecting the ovaries and related areas. It's an open-label study where all participants receive the drug to assess its safety and initial effectiveness.

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue. Since it's an immune-based therapy, there could also be risks of autoimmune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I've had surgery for my cancer, finished platinum-based chemotherapy, and my tumor tissue has been stored.

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My treatment has fully cleared my cancer.

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I have a confirmed advanced high-grade serous cancer of the ovary, fallopian tube, or peritoneum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I have not had major surgery in the last 4 weeks.

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I have not received, nor will I receive, any live vaccines around the time of my treatment.

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I have tested positive for HIV/AIDS.

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I have an infection with hepatitis B or C.

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I am allergic to eggs or similar substances in vaccines.

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I have received immunotherapy or drugs targeting immune checkpoints for cancer.

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I haven't had any cancer except for non-dangerous skin cancer or very early stage cancer in the last 3 years.

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I have had an organ or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 64, 85 and 211

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 64, 85 and 211

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 64, 85 and 211 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability (Adverse Event reported per CTCAE v5)

Secondary study objectives

Best Overall Tumor Response Rate

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

Rate of patients with immune response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TG4050 armExperimental Treatment1 Intervention

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Therapeutic vaccines and immunotherapies for ovarian cancer, such as TG4050, work by stimulating the patient's immune system to recognize and attack cancer cells. These treatments often target specific cancer antigens, which are proteins expressed on the surface of cancer cells but not on normal cells. By training the immune system to identify these antigens, the body can more effectively target and destroy cancer cells. This approach is significant for ovarian cancer patients as it offers a personalized treatment option that can potentially improve outcomes and reduce the likelihood of recurrence by harnessing the body's natural defenses.