RECRUITING

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

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer IMNN-001 GEN-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy (SLL) in Combination With Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Newly Diagnosed With Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Quick Facts

Study Start:2023-02-10

Study Completion:2028-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05739981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects 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 eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology). 2. Subjects 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 clinical determination by their oncology provider. 3. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function. 4. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms. 5. 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. 6. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria. 7. Subjects 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, subjects must discontinue breastfeeding prior to study entry. 8. Subjects must have signed an IRB-approved informed consent. 9. Subjects must be at least 18 years old.	1. Subjects who have received prior treatment with IMNN-001. 2. Subjects 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. 3. Subjects 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 steroid (prednisone equivalent of \> 10 mg/day) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed. 4. Subjects 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 rheumatoid arthritis. 5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded. 6. Subjects with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol therapy. Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma in-situ, etc. are eligible. 7. Subjects 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 more than three years prior to registration, and the subject remains free of recurrent or metastatic disease. 8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the subject remains free of recurrent or metastatic disease. 9. Subjects with known active hepatitis. 10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater). 11. Subjects 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. 12. Subjects with clinically significant cardiovascular disease. 13. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial. 14. Subjects 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 accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. 15. Subjects with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary. 16. Subjects having hemoptysis within the last month. 17. Subjects 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 port placement), intestinal dysfunction, fistulas, or suspected extensive adhesions from prior history or finding at laparoscopy.

Inclusion Criteria

Exclusion Criteria

1. Subjects 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 eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology).
2. Subjects 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 clinical determination by their oncology provider.
3. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.
4. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms.
5. 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.
6. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.
7. Subjects 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, subjects must discontinue breastfeeding prior to study entry.
8. Subjects must have signed an IRB-approved informed consent.
9. Subjects must be at least 18 years old.

1. Subjects who have received prior treatment with IMNN-001.
2. Subjects 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.
3. Subjects 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 steroid (prednisone equivalent of \> 10 mg/day) use not related to chemotherapy administration. Steroid prophylaxis for IV contrast allergy is allowed.
4. Subjects 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 rheumatoid arthritis.
5. Subjects with known human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) infections are excluded.
6. Subjects with other invasive malignancies are excluded if there is any evidence of the invasive malignancy being present within the last three years. Subjects are also excluded if their previous cancer treatment contraindicates this protocol therapy. Subjects with non-invasive malignancies such as non-melanoma skin cancer, melanoma in-situ, etc. are eligible.
7. Subjects 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 more than three years prior to registration, and the subject remains free of recurrent or metastatic disease.
8. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the subject remains free of recurrent or metastatic disease.
9. Subjects with known active hepatitis.
10. Subjects with nephrotic syndrome (proteinuria Grade 2 or greater).
11. Subjects 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.
12. Subjects with clinically significant cardiovascular disease.
13. Subjects of childbearing potential, not practicing adequate contraception, subjects who are pregnant, or subjects who are breastfeeding are not eligible for this trial.
14. Subjects 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 accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
15. Subjects with a history of diverticulitis within the past 6 months. Diverticulosis is not exclusionary.
16. Subjects having hemoptysis within the last month.
17. Subjects 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 port placement), intestinal dysfunction, fistulas, or suspected extensive adhesions from prior history or finding at laparoscopy.

Contacts and Locations

Study Contact

Khursheed Anwer, PhD

CONTACT

609.896.9100

kanwer@imunon.com

Lauren Musso

CONTACT

609.896.9100

lmusso@imunon.com

Principal Investigator

Amir Jazaeri, MD

STUDY_CHAIR

University of Texas MD Anderson Center

Study Locations (Sites)

Johns Hopkins Medicine SKCCC

Baltimore, Maryland, 21231

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Imunon

Amir Jazaeri, MD, STUDY_CHAIR, University of Texas MD Anderson Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10

Study Completion Date2028-01-30

Study Record Updates

Study Start Date2023-02-10

Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

IMNN-001
GEN-1

Additional Relevant MeSH Terms

Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer