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New treatment option for Ovarian Cancer
Official title Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer
ClinicalTrials.gov ID: NCT05739981
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- people with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly...
- people must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical...
- people must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.
- people should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within...
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone...
You likely can't join if
- people who have received prior treatment with IMNN-001.
- people who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used...
- people who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical...
- people with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus...
- people with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.
- people with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years...
See the full eligibility criteria
- people with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are...
- people must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard...
- people must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.
- people should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. people with diagnosis of COVID-19 infection...
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
- people must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.
- people of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and agree to practice an effective form of contraception. If applicable, people must...
- people must have signed an IRB-approved informed consent.
- people must be at least 18 years old.
- people who have received prior treatment with IMNN-001.
- people who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study.
- people who have received oral or parenteral corticosteroids within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic...
- people with autoimmune disease requiring immunosuppressive therapy within the last 2 years. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and...
- people with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.
- people with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. people are also excluded if their previous cancer treatment...
- people who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed...
- people who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. people may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than...
- people with known active hepatitis.
- people with nephrotic syndrome (proteinuria Grade 2 or greater).
- people with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the subject to extreme risk or decreased life expectancy.
- people with clinically significant cardiovascular disease.
- people of childbearing potential, not practicing adequate contraception, people who are pregnant, or people who are breastfeeding are not eligible for this trial.
- people with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular...
- people with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary.
- people having hemoptysis within the last month.
- people with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reasons other than IP...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; New York, New York, United States; Oklahoma City, Oklahoma, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.