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Custom-Made vaccine takes on ovarian cancer

NCT ID NCT03839524

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 1 trial tested a personalized immunotherapy called TG4050 in 64 women with advanced ovarian, fallopian tube, or peritoneal cancer who had completed standard chemotherapy and were in complete remission. The treatment is made from each patient's unique tumor mutations and given as injections to help the immune system recognize and attack any remaining cancer cells. The main goal was to check safety and tolerability, with some early looks at whether it might help prevent recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TG4050 (a personalized cancer vaccine made from the patient's own tumor mutations)
What this could lead to
If successful, this could point toward a new way to keep ovarian cancer from coming back after standard treatment.
What could go wrong
This is an early Phase 1 trial with only 64 participants, so it is mainly checking safety, not yet proven to work. The treatment is personalized and complex, which may limit how widely it can be used.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Dec 2019

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed written informed consent. 2. Female patients ≥ 18 years 3. Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma. 4. 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. 5. Patients must have achieved a complete response to therapy 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation 7. Adequate hematological, hepatic and renal functions. Exclusion Criteria: 1. 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) 2. Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma. 3. Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. 4. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome). 5. Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products. 6. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV). 7. Major surgery within 4 weeks of treatment start. 8. Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation. 9. Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed. 10. 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. 11. Uncontrolled intercurrent illness.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • IUCT Toulouse

    Toulouse, 31100, France

  • Institut Curie

    Paris, 75005, France

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85259, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

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