Custom-Made vaccine takes on ovarian cancer
NCT ID NCT03839524
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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64 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Hôpital Pitié-Salpêtrière
Paris, 75013, France
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IUCT Toulouse
Toulouse, 31100, France
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Institut Curie
Paris, 75005, France
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Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic Phoenix
Phoenix, Arizona, 85259, United States
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Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a common cholesterol pill help chemotherapy fight ovarian cancer?
- Can a new drug combo keep ovarian cancer from coming back?