Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (NCT04390399)

🧪 Interventions in This Study

• N-803 (BIOLOGICAL)
• Aldoxorubicin HCl (DRUG)
• PD-L1 t-haNK (BIOLOGICAL)
• Nab-paclitaxel (DRUG)
• Gemcitabine (DRUG)
• Cyclophosphamide (DRUG)
• 5-Fluorouracil (DRUG)
• Leucovorin (DRUG)
• Irinotecan liposome (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age ≥ 18 years.
2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
3. Have histologically confirmed unresectable, locally advanced or metastatic pancreatic cancer.
4. For Cohort A, subjects must have initially received, or are currently receiving, continuous treatment with gemcitabine plus nab-paclitaxel for at least 16 weeks and have confirmed PR, CR, or SD prior to receiving first-line maintenance therapy on this study. Duration of actual initial treatment may be unlimited as long as no evidence of disease progression is noted by the Investigator at the time of randomization.
5. For Cohort B, subjects must have PD after receiving initial treatment with FOLFOX, FOLFIRINOX, or a gemcitabine- or paclitaxel-based therapy for pancreatic cancer. Subjects who discontinued prior therapy due to toxicity, intolerance, or available therapy was clinically contraindicated are allowed.
6. For Cohort C, subjects must have PD after receiving at least 2 lines of therapy for pancreatic cancer, including but not limited to neoadjuvant, adjuvant, and/or metastatic settings.
7. ECOG PS of 0 or 1.
8. Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST V1.1.
9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
10. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of study treatment. Non-sterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of study treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, oral contraceptives, and abstinence.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

• Chan Soon-Shiong Institute for Medicine — El Segundo, California
• Hoag memorial Presbyterian Hospital — Newport Beach, California
• Astera Cancer Care — East Brunswick, New Jersey
• Avera Cancer Institute — Sioux Falls, South Dakota

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Pancreatic Cancer

• A Study of Multiparametric Ultrasound Imaging Methods — Basking Ridge, New Jersey
• Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer — Gilbert, Arizona
• Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions — Houston, Texas
• Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations — Tampa, Florida
• A Study of the Life Changes Experienced by Patients With Pancreatic Cancer — New York, New York
• Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma — Aurora, Colorado

Explore by condition: All Pancreatic Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.