Trial 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
NCT ID:
NCT05739981
Condition:
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Conditions: Official terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
Conditions: Keywords:
IMNN-001
GEN-1
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 175 mg/m2 IV
Arm group label:
Chemotherapy + BEV (Control)
Arm group label:
Chemotherapy + BEV + IMNN-001 (Experimental)
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC 5-6 IV
Arm group label:
Chemotherapy + BEV (Control)
Arm group label:
Chemotherapy + BEV + IMNN-001 (Experimental)
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following
cycles: [1] Cycle 1, [2] the last cycle of neoadjuvant therapy immediately preceding ICS,
and [3] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During
the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent
until disease progression or unacceptable toxicity for a maximum of an additional 18
cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars
may be used in this study in place of BEV.
Arm group label:
Chemotherapy + BEV (Control)
Arm group label:
Chemotherapy + BEV + IMNN-001 (Experimental)
Intervention type:
Drug
Intervention name:
IMNN-001
Description:
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
Arm group label:
Chemotherapy + BEV + IMNN-001 (Experimental)
Summary:
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.
Detailed 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. The chemotherapy (NACT & adjuvant) will be
a standard regimen of carboplatin + paclitaxel administered every three weeks for a total
of 7-9 cycles. The protocol requires at least 4 cycles of NACT and allows up to 2
additional cycles of neoadjuvant therapy at the Investigator's discretion based on
response and other clinical considerations. ICS will take place 3-4 weeks from last dose
of NACT. Following at least a 4-week recovery from ICS, 3 additional adjuvant cycles of
study treatments will be administered. The minimum time interval between surgery and BEV
administration will be 4 weeks for safety. BEV will be included at Cycles 2, 3, 6, and 7.
BEV may be substituted by an FDA approved biosimilar. The experimental arm will add
IMNN-001 weekly to each cycle of chemotherapy + BEV beginning with Cycle 1 Day 15 and
continue weekly through the last cycle of adjuvant therapy.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins Medicine SKCCC
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mary Kate Jones
Phone:
443-287-6351
Email:
mjone242@jhmi.edu
Investigator:
Last name:
Stephanie Gaillard, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kelsey Higgins
Email:
higgink1@mskcc.org
Investigator:
Last name:
Chrisann Kyi, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kerri Fernandes
Email:
kefernan@mdanderson.org
Contact backup:
Last name:
Mariana Gallardo
Email:
mgallardo2@mdanderson.org
Investigator:
Last name:
Amir Jazaeri, MD
Email:
Principal Investigator
Start date:
February 10, 2023
Completion date:
January 30, 2028
Lead sponsor:
Agency:
Imunon
Agency class:
Industry
Collaborator:
Agency:
Breakthrough Cancer Research
Agency class:
Other
Source:
Imunon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739981
