The MRD Study

A Phase II Study Evaluating the effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL) When Administered in Combinatiion with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

While the standard of care for stage 3 and 4 ovarian cancer treatment can be successful, the current five-year survival rate still remains low, at less than 50%, with a relapse rate of 70%. There is a significant unmet need for more robust treatment options for ovarian cancer patients and their loved ones.

The 201-21-202 “MRD” Study is a Phase II Study Evaluating the effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) on Second Look Laparoscopy (SLL) When Administered in Combination with Bevacizumab (BEV) and Neoadjuvant Chemotherapy (NACT) in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer. The primary endpoint of the study is to determine if the addition of IMNN-001 can reduce the rate of minimal residual disease (MRD) at SLL from an expected 70% in the control group (chemotherapy + BEV) to 35% in the experimental group (chemotherapy + BEV + IMNN-001). This is a randomized, open label, multicenter trial in which eligible subjects will be assigned 1:1 the to the treatment and control arms. The study will also evaluate progression free survival and overall survival between the two arms.

PROTOCOL
INFORMATION

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Protocol Number: 201‑21‑201

Phase: 2

Enrolling: Up to 50 subjects with newly diagnosed advanced ovarian cancer

Randomization: Randomly assigned 1:1 to receive either chemotherapy, BEV and IMNN-001 or chemotherapy and BEV alone.

IMNN-001

The Investigational Drug

Human IL-12 plasmid (phIL-12-005) is formulated with lipopolymer PEG-PEI-Cholesterol (PPC) in 10% lactose; classified as a biologic (nonviral gene therapeutic)

Infusion into abdominal cavity via an intraperitoneal catheter

Dose: 80 mg/m2

Study Design and Treatment Schedule:


EXCLUSION
CRITERIA

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Key Inclusion Criteria

  • Histologic confirmation of high grade epithelial ovarian, fallopian tube or primary peritoneal cancer

 

  • FIGO stage III or IV and candidate for neoadjuvant chemotherapy

 

  • ECOG of 0 or 1

 

  • Have adequate bone marrow, renal, hepatic, and neurological function

 

  • Are free of active infection for 4 weeks prior to treatment

Key Exclusion Criteria

  • Previously treated

 

  • Have had any other form of cancer in the past 3 years

 

  • Subjects with a history of clinically significant cardiovascular disease, CNS disease, and/or diverticulitis

 

  • Uncontrolled hypertension

The study is based on the findings from the recently published OVATION trial that can be found in Clinical Cancer Research.

Am I Eligible?