Combination Immunotherapy + Chemotherapy for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot use certain medications like strong CYP3A4 or CYP2C8 inhibitors or inducers within 14 days before starting the study. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination used in the clinical trial for pancreatic cancer?
What safety data exists for combination immunotherapy and chemotherapy in pancreatic cancer?
The combination of 5-fluorouracil, nab-paclitaxel, leucovorin, and oxaliplatin (FABLOx) was found to be feasible and tolerable in patients with metastatic pancreatic cancer, though some patients experienced severe side effects like anemia and mucositis (painful inflammation of the mouth). Another study showed that liposomal irinotecan with 5-fluorouracil and leucovorin was well-tolerated in patients whose cancer progressed on other treatments.36789
How is the combination immunotherapy and chemotherapy treatment for pancreatic cancer different from other treatments?
This treatment combines multiple drugs, including 5-fluorouracil, gemcitabine, and nab-paclitaxel, which have shown improved survival rates in pancreatic cancer compared to single-agent therapies. It uniquely integrates both chemotherapy and immunotherapy, potentially offering a more comprehensive approach to targeting cancer cells.12101112
What is the purpose of this trial?
This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort.
Eligibility Criteria
Adults with advanced or metastatic pancreatic cancer who've had certain treatments and have specific responses can join. They must be able to follow the study plan, agree to use contraception, and not have other serious health issues or recent participation in other drug studies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard-of-care chemotherapy with or without combination immunotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5-Fluorouracil
- Aldoxorubicin HCl
- Cyclophosphamide
- Gemcitabine
- Irinotecan liposome
- Leucovorin
- N-803
- Nab-paclitaxel
- PD-L1 t-haNK
- SBRT
5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Ovarian cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImmunityBio, Inc.
Lead Sponsor
Richard Adcock
ImmunityBio, Inc.
Chief Executive Officer since 2024
Information not available
Dr. Patrick Soon-Shiong
ImmunityBio, Inc.
Chief Medical Officer since 2021
MD