Pancreatic CancerPhase 2NCT05494697
Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC
A Phase 2 study testing Rintatolimod in people with Pancreatic Cancer, run by AIM ImmunoTech Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Rintatolimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2027to Mar 2031
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer.
- Measurable disease per RECIST v.1.1.
- Completion of at least four (4) months of first line therapy, such as FOLFIRINOX and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan after last first-line therapy and prior to randomization.
- Subject must meet one of the following criteria for stratification question of 'Is subject planned to receive chemoradiation therapy as SOC? [Yes/No]' A. For subjects to be enrolled under stratification of 'Yes, SOC includes chemoradiation', subjects are planned to receive the following allowable radiotherapy and chemotherapy, with curative intent (i.e., not palliative).
- Allowable SOC radiotherapy:
- IMRT (Intensity-Modulated Radiation Therapy)
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- SBRT (Stereotactic Body Radiation Therapy)
- Allowable SOC chemotherapy:
- Capecitabine
- 5-Fluorouracil (5-FU) +/- irinotecan B. For subjects to be enrolled under stratification of 'No, SOC does not include chemoradiation', subjects are planned to receive chemotherapy alone or undergo surveillance for disease progression only.
- Male or non-pregnant, non-lactating female, ≥18 years or age.
- Negative serum pregnancy test at screening visit for female subjects of childbearing potential. Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after last study treatment administration.
- Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device).
- Female subject/partners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.
- All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom from screening up until 90 days after last study treatment administration. In addition, subjects may not donate sperm for the same time period.
- Provide signed written informed consent and willingness, ability to comply with study requirements.
- Minimum weight of 40kg at screening.
- Karnofsky Performance Status of 80 or higher at screening.
- Subject must have a projected life expectancy of ≥ 3 months in the opinion of the Investigator.
- Subject has adequate organ function by the following laboratory assessments at screening (after the last dose of first-line therapy treatment and prior to randomization):
- Hematologic:
- Platelets ≥ 100×10^9/L Hemoglobin ≥ 9.0 g/dL Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L WBC ≥ 3 x 10^9/L Neutrophil/Lymphocyte (N/L) ratio < 4.5
- 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, aPTT and INR within normal limits
Who cannot join
- Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma.
- Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma following treatment with first-line therapy, such as FOLFIRINOX.
- Subject has received prior treatment with Ampligen®.
- Therapy with investigational drugs within 6 weeks of beginning study medication.
- 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.
- 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.
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- Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous (IV) treatment for infection(s).
- Known history of positivity (regardless of immune status) for human immunodeficiency virus (HIV).
- Known history of, chronic active, or active viral hepatitis A, B, or C infection
- Clinically significant bleeding within 2 weeks prior to Randomization (e.g., gastrointestinal [GI] bleeding, intracranial hemorrhage).
- Pregnant or lactating women.
- 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.
- Subjects with abnormal electrocardiogram (ECG) at screening with QTc interval >470 ms (calculated using both the Bazett's and Fridericia's corrections).
- Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2 weeks.
- 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.
- Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD- L1).
- Inability to return for scheduled treatment and assessments.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Nebraska Medical Center
Omaha, Nebraska, 68198
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma
The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma
Read the detailed description
This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and safety of Ampligen treatment combined with standard of care (SOC) versus SOC alone following First-line therapy in subjects with locally advanced pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- Rintatolimod
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RintatolimodDrug
Also called Ampligen, poly I : poly C12U
Rintatolimod (poly I : poly C12U)
| Study group | Role | What they receive |
|---|---|---|
| Ampligen / rintatolimod + SOC Chemoradiation | Experimental | Subjects will receive rintatolimod [intravenous (IV)], up to 400 mg twice weekly plus SOC chemoradiation until disease progression Receives: Drug: Rintatolimod |
| SOC Chemoradiation Alone | No intervention | Subjects will receive SOC chemoradiation until evidence of disease progression. |
| Ampligen / rintatolimod + SOC | Experimental | Subjects will receive rintatolimod [intravenous (IV)], up to 400 mg twice weekly plus SOC (SOC does not include chemoradiation) until disease progression Receives: Drug: Rintatolimod |
| SOC Alone | No intervention | Subjects will receive SOC (SOC does not include chemoradiation) until evidence of disease progression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and iRECIST (the initial progressive disease (PD)) or death due to any cause.
Measured: Randomization until disease progression, death, or end of study up to 182 weeks
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as patients who are alive at time of analysis
Measured: Randomization to death due to any cause, or end of study up to 182 weeks.
Overall Survival (OS) at 1 year
OS is defined as the time from date of Randomization to death due to any cause.
Measured: Randomization to death due to any cause.at 1 year
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 and iRECIST
Measured: Randomization until disease progression, death, or end of study up to 182 weeks
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 per RECIST v1.1 and iRECIST or death due to any cause, whichever occurs first.
Measured: Randomization until disease progression, death, or end of study up to 182 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study startAug 2027 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionMar 2031 (estimated)
Why it stopped: A business decision to place screening/enrollment on hold. Study redesign/amendment pending additional Ampligen-related data from an ongoing Phase I-II open label study (NCT05927142)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIM ImmunoTech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- David R Strayer, MD, Study director, AIM ImmunoTech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494697
- Sponsor's protocol ID
- AMP-270
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35326528
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05494697
- Acronym / sponsor ID
- AMP-270
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: A business decision to place screening/enrollment on hold. Study redesign/amendment pending additional Ampligen-related data from an ongoing Phase I-II open label study (NCT05927142)
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AIM ImmunoTech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- Aug 2027 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma
Detailed description
This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and safety of Ampligen treatment combined with standard of care (SOC) versus SOC alone following First-line therapy in subjects with locally advanced pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ampligen / rintatolimod + SOC Chemoradiation | Experimental | Drug: RintatolimodSubjects will receive rintatolimod [intravenous (IV)], up to 400 mg twice weekly plus SOC chemoradiation until disease progression |
| SOC Chemoradiation Alone | No intervention | –Subjects will receive SOC chemoradiation until evidence of disease progression. |
| Ampligen / rintatolimod + SOC | Experimental | Drug: RintatolimodSubjects will receive rintatolimod [intravenous (IV)], up to 400 mg twice weekly plus SOC (SOC does not include chemoradiation) until disease progression |
| SOC Alone | No intervention | –Subjects will receive SOC (SOC does not include chemoradiation) until evidence of disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer.
- Measurable disease per RECIST v.1.1.
- Completion of at least four (4) months of first line therapy, such as FOLFIRINOX and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan after last first-line therapy and prior to randomization.
- Subject must meet one of the following criteria for stratification question of 'Is subject planned to receive chemoradiation therapy as SOC? [Yes/No]' A. For subjects to be enrolled under stratification of 'Yes, SOC includes chemoradiation', subjects are planned to receive the following allowable radiotherapy and chemotherapy, with curative intent (i.e., not palliative).
- Male or non-pregnant, non-lactating female, ≥18 years or age.
Key exclusion criteria (17 listed)
- Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma.
- Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma following treatment with first-line therapy, such as FOLFIRINOX.
- Subject has received prior treatment with Ampligen®.
- Therapy with investigational drugs within 6 weeks of beginning study medication.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RintatolimodAlso: Ampligen, poly I : poly C12URintatolimod (poly I : poly C12U) | Drug | Ampligen / rintatolimod + SOC, Ampligen / rintatolimod + SOC Chemoradiation |
Primary outcome
Progression Free Survival (PFS)
Time frame: Randomization until disease progression, death, or end of study up to 182 weeks
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 and iRECIST (the initial progressive disease (PD)) or death due to any cause.
4 secondary outcomes
Overall Survival (OS)
Time frame: Randomization to death due to any cause, or end of study up to 182 weeks.
Overall Survival (OS) at 1 year
Time frame: Randomization to death due to any cause.at 1 year
Objective Response Rate (ORR)
Time frame: Randomization until disease progression, death, or end of study up to 182 weeks
Duration of Response (DoR)
Time frame: Randomization until disease progression, death, or end of study up to 182 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 35326528El 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Strayer, MD study director
AIM ImmunoTech Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rintatolimod in people with Pancreatic Cancer, run by AIM ImmunoTech Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Randomization until disease progression, death, or end of study up to 182 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.