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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 64, 85 and 211
Awards & highlights
Study Summary
This trial is testing a new drug for ovarian, fallopian, or peritoneal cancer. They will be testing how safe and tolerable the drug is, as well as how it affects the cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability (Adverse Event reported per CTCAE v5)
Secondary outcome measures
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: TG4050 armExperimental Treatment1 Intervention
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
Find a Location
Who is running the clinical trial?
TransgeneLead Sponsor
22 Previous Clinical Trials
1,595 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I do not have any unmanaged ongoing illnesses.I have not had major surgery in the last 4 weeks.I've had surgery for my cancer, finished platinum-based chemotherapy, and my tumor tissue has been stored.My treatment has fully cleared my cancer.My blood, liver, and kidney functions are all within normal ranges.I am on long-term steroids or other drugs that weaken my immune system, but I can use creams or inhalers.I have not received, nor will I receive, any live vaccines around the time of my treatment.I have tested positive for HIV/AIDS.I have an infection with hepatitis B or C.I am allergic to eggs or similar substances in vaccines.I have received immunotherapy or drugs targeting immune checkpoints for cancer.I haven't had any cancer except for non-dangerous skin cancer or very early stage cancer in the last 3 years.I have had an organ or bone marrow transplant.I have a confirmed advanced high-grade serous cancer of the ovary, fallopian tube, or peritoneum.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: TG4050 arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment number for this research endeavor?
"Affirmative, the data present on clinicaltrials.gov reveals that this research is currently looking for volunteers. This trial was initially uploaded on December 9th 2019 and recently revised on September 22nd 2021. 23 participants are required from 3 distinct locations to take part in the study."
Answered by AI
Is enrollment in this trial currently available to participants?
"According to data accessible from clinicaltrials.gov, this scientific trial is actively looking for participants. It was initially posted on the 9th of December in 2019 and recently updated on the 22nd of September 2021."
Answered by AI
What have the safety assessments revealed about TG4050?
"Due to the limited clinical data available, TG4050 was assigned a score of 1 for safety. This is in part due to it being an early stage Phase 1 trial without much evidence supporting efficacy or security."
Answered by AI
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