Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My pancreatic cancer worsened after initial treatment with specific chemotherapy.
Select...
I have at least one tumor that can be measured or evaluated.
Select...
I've been treated with gemcitabine and nab-paclitaxel for 16 weeks and my cancer hasn't worsened.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My pancreatic cancer cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Objective response rate (ORR), Complete response (CR) rate, and Disease Control Rate (DCR)
Overall Survival (OS)
Quality of Life (QoL)
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
~2070
N-803
2021
Completed Phase 2
~30
SBRT
2014
Completed Phase 2
~1060
Nab-paclitaxel
2014
Completed Phase 3
~2030
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
4,808 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.I do not have any serious illnesses that would make the study drug unsafe for me.I have at least one tumor that can be measured or evaluated.I haven't taken part in any drug studies or received experimental treatments in the last 14 days, except for prostate cancer or COVID-19 treatments.I can attend all required study visits and follow-ups.I am fully active or restricted in physically strenuous activity but can do light work.I stopped my previous cancer treatment because it was harmful or not suitable for me.My pancreatic cancer worsened after initial treatment with specific chemotherapy.I've been treated with gemcitabine and nab-paclitaxel for 16 weeks and my cancer hasn't worsened.I agree to use effective birth control during and up to 5 months after the study.My body weight is 40 kg or less.I need oxygen all the time due to my advanced cancer.My pancreatic cancer has worsened after at least 2 treatments.I have a systemic autoimmune disease like lupus or rheumatoid arthritis.I have not taken certain medications recently.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.I am on daily medication with steroids for a long-term condition.I haven't had any other cancer needing treatment or taken gemcitabine or nab-paclitaxel in the last 5 years.I have had liposomal irinotecan for my advanced pancreatic cancer.My tumor has a BRCA1 or BRCA2 gene mutation.My pancreatic cancer cannot be removed by surgery and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A Control Treatment Arm
- Group 2: Cohort A Experimental Treatment Arm 2
- Group 3: Cohort A Experimental Treatment Arm 1
- Group 4: Cohort B Experimental Treatment Arm
- Group 5: Cohort B Control Treatment Arm
- Group 6: Cohort C Experimental Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other scientific investigations have included research into PD-L1 t-haNK?
"PD-L1 t-haNK was first studied by the City of Hope Comprehensive Cancer Center in 1997. To this day, it has been tested extensively with 3697 completed trials and 2237 actively recruiting clinical studies; a substantial portion of these occurring in El Segundo, California."
Answered by AI
What potential harm is associated with PD-L1 t-haNK treatment?
"The estimated safety of PD-L1 t-haNK is assessed to be a 2, as this Phase 2 trial has produced some evidence on their safety but not yet any efficacy data."
Answered by AI
What is the recruitment rate for this clinical trial?
"Affirmative. According to clinicaltrials.gov, the recruiting process for this trial began on July 21st 2020 and was recently updated on October 26th 2022. 328 participants need to be enrolled from 4 distinct locations around the country."
Answered by AI
How widespread is the implementation of this experiment?
"A few of the 4 participating medical sites include Chan Soon-Shiong Institute for Medicine in El Segundo, Hoag Memorial Presbyterian Hospital in Newport Beach and Avera Cancer Institute in Sioux Falls."
Answered by AI
Are researchers currently seeking participants for this clinical trial?
"According to clinicaltrials.gov, enrollment for this trial is now open. The study was first publicized on July 21st 2020 and recently updated on October 26th 2022."
Answered by AI
In what medical circumstances is PD-L1 t-haNK commonly prescribed?
"PD-L1 t-haNK can be used to mitigate the symptoms of lymphoma, acute lymphoblastic leukemia (ALL), and actinic keratosis."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger