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Chemotherapy

Combination Immunotherapy + Chemotherapy for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
For Cohort B, subjects must have PD after receiving initial treatment with FOLFOX, FOLFIRINOX, or a gemcitabine- or paclitaxel-based therapy for pancreatic cancer
Must not have
Inadequate organ function, evidenced by specific laboratory results
Uncontrolled hypertension or clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for pancreatic cancer patients who have already tried other treatments. The new combination includes aldoxorubicin, N-803, and PD-L1 t-haNK, and the goal is to find out if it is more effective and has fewer side effects than the current standard of care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions related to immune system activation (like inflammation), typical chemotherapy effects such as nausea, fatigue, hair loss, blood cell count changes, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My pancreatic cancer worsened after initial treatment with specific chemotherapy.
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I have at least one tumor that can be measured or evaluated.
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I've been treated with gemcitabine and nab-paclitaxel for 16 weeks and my cancer hasn't worsened.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My pancreatic cancer cannot be removed by surgery and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lab tests show my organs are not functioning well.
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I have high blood pressure or heart problems that are not well-managed.
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I have had an organ transplant and take medicine to prevent rejection.
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I do not have any serious illnesses that would make the study drug unsafe for me.
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My body weight is 40 kg or less.
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I need oxygen all the time due to my advanced cancer.
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I have a systemic autoimmune disease like lupus or rheumatoid arthritis.
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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.
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I am on daily medication with steroids for a long-term condition.
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I haven't had any other cancer needing treatment or taken gemcitabine or nab-paclitaxel in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Objective response rate (ORR), Complete response (CR) rate, and Disease Control Rate (DCR)
Quality of Life (QoL)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
N-803
2021
Completed Phase 2
~80
Nab-paclitaxel
2014
Completed Phase 3
~1950
Cyclophosphamide
2010
Completed Phase 4
~2310
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
66 Previous Clinical Trials
4,437 Total Patients Enrolled

Media Library

5-Fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04390399 — Phase 2
Pancreatic Cancer Research Study Groups: Cohort A Control Treatment Arm, Cohort A Experimental Treatment Arm 2, Cohort A Experimental Treatment Arm 1, Cohort B Experimental Treatment Arm, Cohort B Control Treatment Arm, Cohort C Experimental Treatment Arm
Pancreatic Cancer Clinical Trial 2023: 5-Fluorouracil Highlights & Side Effects. Trial Name: NCT04390399 — Phase 2
5-Fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04390399 — Phase 2
~57 spots leftby Oct 2025
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