A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

Phase 2

Not yet recruiting

• Conditions: Locally Advanced Pancreatic Adenocarcinoma; Pancreas cancer; 10015674; 10017991

• Registration Number: NL-OMON56480
• Lead Sponsor: AIM ImmunoTech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Subjects will be eligible for enrollment in the study only if they meet ALL the
following criteria at time of Screening:
1. Histological diagnosis of pancreatic adenocarcinoma confirmed
pathologically: Unresectable pancreatic cancer; locally advanced pancreatic
cancer.
2. Measurable disease per RECIST v.1.1.
3. Completion of at least four (4) months of first line FOLFIRINOX treatment
and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography
(CT) or Magnetic Resonance Imaging (MRI) scan 4 to 6 weeks after last
FOLFIRINOX treatment.
4. Male or non-pregnant, non-lactating female, >=18 years or age.
5. Negative pregnancy test for female subjects. Women of child-bearing
potential (WOCBP) and Women not of child-bearing potential are eligible to
participate. Both women of child-bearing potential and women of
non-child-bearing potential should use an approved method of birth control and
agrees to continue to use this method for the duration of the study and for 90
days after last treatment.
Acceptable methods of contraception include abstinence, female
subject/partner*s use of hormonal contraceptive (oral, implanted, or injected)
in conjunction with a barrier method (WOCBP only), female subject/partner*s use
of an intrauterine device (IUD), or if the female subject/partner is surgically
sterile or two years post-menopausal. All male subjects/partners must agree to
use a condom consistently and correctly for the duration of the study and for
90 days after last treatment. In addition, subjects may not donate sperm for
the duration of the study and for 90 days after last treatment.
Females who are less than two (2) years post-menopausal, those with tubal
ligations and those using contraception must have a negative serum pregnancy
test at baseline within the one (1) week prior to the first study medication
infusion. Every six weeks, and at study termination a pregnancy test should be
performed, either serum or urine stick test. However, if the urine result is
positive, a serum pregnancy test will be performed.
Any pregnancy that occurs while taking Ampligen® should be recorded using a
Pregnancy Report Form and reported immediately to AIM ImmunoTech, Inc.
6. Provide signed written informed consent and willingness, ability to comply
with study requirements.
7. Minimum weight of 40kg at baseline.
8. Karnofsky Performance Status of 80 or higher at baseline.
9. Subject must have a projected life expectancy of >= 3 months in the opinion
of the Investigator.
10. Subject has adequate organ function by the following laboratory assessments
at baseline (obtained <= 28 days prior to V2 / First treatment):
Hematologic
Platelets >= 100×109/L
Hemoglobin >= 9.0 g/dL
Absolute Neutrophil Count (ANC) >= 1.5×109/L
Absolute lymphocyte count >= 3 x 109/L
Hepatic
AST/ALT <= 3×ULN (if liver metastases are present, <= 5×ULN)
Alkaline phosphatase <= 2.0×ULN (if liver metastases are present, <= 5×ULN)
Total bilirubin <= 1.5×ULN
Albumin >= 3.0 g/dL
Renal
Creatinine clearance >= 60 mL/min using the Cockcroft-Gault formula. .
Coagulation
PT-INR and APTT within normal limits

Exclusion Criteria

meeting ANY of the following criteria at time of Screening will be excluded
from enrollment:
1. Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e.,
lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
cystadenocarcinoma.
2. Subjects who have surgically resectable locally advanced pancreatic
adenocarcinoma following treatment with FOLFIRINOX.
3. Subject has received prior treatment with Ampligen®.
4. Therapy with investigational drugs within 6 weeks of beginning study
medication.
5. History of prior malignancy, except for adequately treated in situ cancer,
basal cell, squamous cell skin cancer, or other cancers (e.g., breast,
prostate) for which the subject has been disease-free for at least 3 years.
Subjects with prior cancer that is adequately controlled per the judgement of
the Investigator will not be excluded from the study.
6. Any serious medical condition, laboratory abnormality, psychiatric illness,
or comorbidity that, in the judgment of the Investigator, would make the
subject inappropriate for the study.
7. Serious systemic fungal, bacterial, viral, or other infection that is not
controlled or requires intravenous (IV) treatment for infection(s).
8. Known history of positivity (regardless of immune status) for human
immunodeficiency virus (HIV).
9. Known history of, chronic active, or active viral hepatitis A, B, or C
infection
10. Clinically significant bleeding within 2 weeks prior to Randomization
(e.g., gastrointestinal [GI] bleeding, intracranial hemorrhage).
11. Pregnant or lactating women.
12. Myocardial infarction within the last 6 months prior to Randomization,
symptomatic congestive heart failure (New York Heart Association Classification
> Class II), unstable angina, or unstable cardiac arrhythmia requiring
medication.
13. Subjects with abnormal electrocardiogram (ECG) at baseline QTc interval
>470 ms. Both Bazett*s and Fridericia*s corrections need to be applied; if
either is >470 ms; subject is not eligible.
14. Subjects with positive germline BRCA (gBRCA) mutations.
15. Clinically significant ascites defined as requiring >= 1 paracentesis every
2 weeks.
16. Major surgery, defined as any surgical procedure that involves general
anesthesia and a significant incision (i.e., larger than what is required for
placement of central venous access, percutaneous feeding tube, or biopsy),
within 28 days prior to Randomization or anticipated surgery during the study
period.
17. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4,
anti-PD1, anti-PD- L1).
18. Inability to return for scheduled treatment and assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival (PFS) [Time Frame: Visit 2/ First Treatment until<br /><br>disease progression, death, or end of study up to 42 months]<br /><br>PFS is defined as the time, in months, from date of Visit 2/ First Treatment to<br /><br>date of the first documentation of definitive disease progression as per RECIST<br /><br>v1.1 (the initial progressive disease (PD)) or death due to any cause. Patients<br /><br>will be classified by the investigator as having disease progression at the<br /><br>time of initial imaging that meets RECIST version 1.1 criteria for disease<br /><br>progression.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Overall Survival (OS)<br /><br>OS is defined as the time from date of Visit 2/ First Treatment to death due to<br /><br>any cause.<br /><br>• Overall Survival (OS) at 1 year<br /><br>• Objective Response Rate (ORR) [Time Frame: Visit 2/ First Treatment until<br /><br>disease progression per RECIST v.1.1, death, or end of study up to 42 months]<br /><br>ORR is defined as the proportion of subjects who achieve a Complete Response<br /><br>(CR) or Partial Response (PR) as assessed by RECIST v1.1.<br /><br>• Duration of Response (DoR) [Time Frame: Visit 2/ First Treatment until<br /><br>disease progression per RECIST v.1.1, death, or end of study up to 42 months]<br /><br>DoR is defined as the time from the date of the first documentation of<br /><br>objective tumor response (CR or PR) to the date of the first documentation of<br /><br>objective tumor progression or death due to any cause, whichever occurs first.</p><br>