Ampligen Compared to No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494697
• Other study ID #: AMP-270
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: AIM ImmunoTech Inc.
• Contact: Diane Young
• Phone: 352-448-7797
• Email: diane.young[@]aimimmuno.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Description:

This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and safety of Ampligen treatment compared to a control group / no treatment following FOLFIRINOX treatment in subjects with locally advanced pancreatic adenocarcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 the 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 Visit 2/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:

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 (calculated using both the Bazett's and Fridericia's corrections).

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

Drug:
• Rintatolimod
Rintatolimod (poly I : poly C12U)

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Nebraska Medical Center	Omaha	Nebraska
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AIM ImmunoTech Inc.	Amarex Clinical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

El Haddaoui H, Brood R, Latifi D, Oostvogels AA, Klaver Y, Moskie M, Mustafa DA, Debets R, van Eijck CHJ. Rintatolimod (Ampligen(R)) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program. Cancers (Basel). 2022 Mar 8;14(6):1377. doi: 10.3390/cancers14061377. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is defined as the time, in months, from date of randomization to date of the first documentation of definitive disease progression as per RECIST v1.1 (the initial progressive disease (PD)) or death due to any cause.	Visit 2/First Treatment until disease progression, death, or end of study up to 42 months
Secondary	Overall Survival (OS)	OS is defined as patients who are alive at time of analysis	Visit 2/First Treatment to death due to any cause, or end of study up to 182 weeks.
Secondary	Overall Survival (OS) at 1 year	OS is defined as the time from date of Visit 2/First Treatment to death due to any cause.	Visit 2/First Treatment to death due to any cause.at 1 year
Secondary	Objective Response Rate (ORR)	ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1	Visit 2/First Treatment until disease progression, death, or end of study up to 42 months
Secondary	Duration of Response (DoR)	DoR is defined as the time from the date of the first documentation of objective tumor response (CR or PR) to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first.	Visit 2/First Treatment until disease progression, death, or end of study up to 42 months