328 Participants Needed

Combination Immunotherapy + Chemotherapy for Pancreatic Cancer

Recruiting at 3 trial locations
JF
KB
PB
Overseen ByPaula Bradshaw
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ImmunityBio, Inc.
Must be taking: Gemcitabine, Nab-paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that combinations like FOLFIRINOX (which includes 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) and gemcitabine plus nab-paclitaxel improve survival in patients with advanced pancreatic cancer compared to using gemcitabine alone.12345

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

Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines
I have at least one tumor that can be measured or evaluated.
I can attend all required study visits and follow-ups.
See 7 more

Exclusion Criteria

My lab tests show my organs are not functioning well.
I have high blood pressure or heart problems that are not well-managed.
I have had an organ transplant and take medicine to prevent rejection.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care chemotherapy with or without combination immunotherapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • 5-Fluorouracil
  • Aldoxorubicin HCl
  • Cyclophosphamide
  • Gemcitabine
  • Irinotecan liposome
  • Leucovorin
  • N-803
  • Nab-paclitaxel
  • PD-L1 t-haNK
  • SBRT
Trial Overview The trial is testing if adding aldoxorubicin HCl, N-803, and PD-L1 t-haNK to standard chemotherapy works better for treating pancreatic cancer. It's an open-label phase 2 study with three separate groups based on previous treatment response.
Participant Groups
6Treatment groups
Experimental Treatment
Active Control
Group I: Cohort C Experimental Treatment ArmExperimental Treatment7 Interventions
SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK
Group II: Cohort B Experimental Treatment ArmExperimental Treatment7 Interventions
SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
Group III: Cohort A Experimental Treatment Arm 2Experimental Treatment7 Interventions
SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
Group IV: Cohort A Experimental Treatment Arm 1Experimental Treatment6 Interventions
SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803
Group V: Cohort A Control Treatment ArmActive Control3 Interventions
SBRT + gemcitabine + nab-paclitaxel
Group VI: Cohort B Control Treatment ArmActive Control3 Interventions
Irinotecan liposome + 5-FU/leucovorin

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Ovarian cancer
🇺🇸
Approved in United States as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
🇨🇦
Approved in Canada as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
🇯🇵
Approved in Japan as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

ImmunityBio, Inc.

Lead Sponsor

Trials
75
Recruited
5,000+

Richard Adcock

ImmunityBio, Inc.

Chief Executive Officer since 2024

Information not available

Dr. Patrick Soon-Shiong

ImmunityBio, Inc.

Chief Medical Officer since 2021

MD

Findings from Research

A study of 5465 patients with advanced pancreatic cancer in Ontario showed that the introduction of new chemotherapy regimens, GEMNAB and FOLFIRINOX, significantly improved overall survival rates over time, with median survival increasing from 5.6 months to 7.6 months between 2008 and 2018.
FOLFIRINOX was found to provide better overall survival compared to GEMNAB, particularly in younger and healthier patients, while GEMNAB still showed improved survival compared to the older standard treatment, gemcitabine.
The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer.Raphael, MJ., Raskin, W., Habbous, S., et al.[2023]
The introduction of FOLFIRINOX and gemcitabine plus nab-paclitaxel therapy significantly improved treatment outcomes for metastatic pancreatic cancer, with response rates increasing from 7.8% to 28.4% after these therapies were introduced.
Patients treated with the newer therapies experienced longer median progression-free survival (3.1 months to 5.4 months) and median overall survival (6.7 months to 10.2 months), indicating a substantial benefit in daily clinical practice.
Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis.Sasaki, T., Kanata, R., Yamada, I., et al.[2022]
In a study of 485 patients with localized pancreatic cancer, those treated with FOLFIRINOX showed higher rates of partial response according to RECIST criteria compared to those treated with gemcitabine plus nab-paclitaxel (GA), indicating better initial tumor response.
Despite the higher response rates and more frequent surgeries (pancreatectomy) in the FOLFIRINOX group, overall survival rates were similar between the two treatment regimens, suggesting that while FOLFIRINOX may be more effective in shrinking tumors, it does not necessarily lead to longer survival.
Response and Survival Associated With First-line FOLFIRINOX vs Gemcitabine and nab-Paclitaxel Chemotherapy for Localized Pancreatic Ductal Adenocarcinoma.Perri, G., Prakash, L., Qiao, W., et al.[2022]

References

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. [2023]
Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis. [2022]
Response and Survival Associated With First-line FOLFIRINOX vs Gemcitabine and nab-Paclitaxel Chemotherapy for Localized Pancreatic Ductal Adenocarcinoma. [2022]
A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. [2022]
Sequential first-line treatment with nab-paclitaxel/gemcitabine and FOLFIRINOX in metastatic pancreatic adenocarcinoma: GABRINOX phase Ib-II controlled clinical trial. [2022]
Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group. [2022]
A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407). [2023]
A Phase I/II Open-Label Multicenter Single-Arm Study of FABLOx (Metronomic 5-Fluorouracil Plus nab-Paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin) in Patients with Metastatic Pancreatic Cancer. [2023]
Comparison of FOLFIRINOX vs Gemcitabine Plus Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma. [2023]
Systemic therapy for advanced pancreatic cancer. [2022]
Neoadjuvant FOLFIRINOX for borderline resectable pancreas cancer: a new treatment paradigm? [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Phase II clinical trial of 5-fluorouracil, trimetrexate, and leucovorin (NFL) in patients with advanced pancreatic cancer. [2018]
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