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Pancreatic CancerPhase 2NCT04390399

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

A Phase 2 study testing N-803, Aldoxorubicin HCl and PD-L1 t-haNK in people with Pancreatic Cancer, run by ImmunityBio, Inc. at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
N-803, Aldoxorubicin HCl and PD-L1 t-haNK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
328 participants
Where
4 sitesUnited States
Study dates
21 Jul 2020to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  • Have histologically confirmed unresectable, locally advanced or metastatic pancreatic cancer.
  • 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.
  • 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.
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  • 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.
  • ECOG PS of 0 or 1.
  • Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST V1.1.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • 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.

Who cannot join

  • Body weight ≤ 40 kg at screening.
  • Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
  • Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
  • For Cohort A only: tumors harboring germline BRCA1/2 mutations.
  • For Cohort B only: previous treatment with liposomal irinotecan for advanced or metastatic pancreatic cancer.
  • History of organ transplant requiring immunosuppression.
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  • History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • Inadequate organ function, evidenced by the following laboratory results:
  • Absolute neutrophil count (ANC) < 1000 cells/mm3.
  • Platelet count < 100,000 cells/mm3.
  • Hemoglobin < 9 g/dL.
  • Total bilirubin greater than two times the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
  • Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
  • Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L.
  • Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3.
  • Albumin <3.0.
  • Ascites requiring paracentesis.
  • Each site should use its own institution's ULN to determine eligibility.
  • Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  • Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to dosing for this study, except for testosterone-lowering therapy in men with prostate cancer or FDA-authorized drugs for the prevention and treatment of COVID-19.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women. A negative serum pregnancy test during screening and a negative pregnancy test within 72 hours prior to the first dose must be documented before study drug is administered to a female subject of child-bearing potential.
  • Any other cancer within the past 5 years that is progressing or requires active treatment, or any previous cancer treatment within the last 5 years that included gemcitabine or nab-paclitaxel.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

  • Hoag memorial Presbyterian Hospital

    Newport Beach, California, 92663

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

Other trials in United States

About this study

Official title: Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

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.

Being tested
N-803, Aldoxorubicin HCl, PD-L1 t-haNK, Nab-paclitaxel, Gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-803Biological

    Recombinant human super agonist interleukin-15 (IL-15) complex

  • Aldoxorubicin HClDrug

    Aldoxorubicin hydrochloride

  • PD-L1 t-haNKBiological

    PD-L1 t-haNK suspension for infusion

  • Nab-paclitaxelDrug

    Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

  • GemcitabineDrug

    2', 2'-difluoro 2'deoxycytidine, dFdC

  • CyclophosphamideDrug

    2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

  • 5-FluorouracilDrug

    5-fluoro-2,4 (1H,3H)-pyrimidinedione

  • LeucovorinDrug

    L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt

  • SBRTProcedure or surgery

    Stereotactic Body Radiation Therapy

  • Irinotecan liposomeDrug

    Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate

Study groups in NCT04390399
Study groupRoleWhat they receive
Cohort A Control Treatment ArmActive comparatorSBRT + gemcitabine + nab-paclitaxel
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Procedure: SBRT
Cohort A Experimental Treatment Arm 1ExperimentalSBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803
Receives: Biological: N-803; Drug: Aldoxorubicin HCl; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cyclophosphamide; Procedure: SBRT
Cohort A Experimental Treatment Arm 2ExperimentalSBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
Receives: Biological: N-803; Drug: Aldoxorubicin HCl; Biological: PD-L1 t-haNK; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cyclophosphamide; Procedure: SBRT
Cohort B Control Treatment ArmActive comparatorIrinotecan liposome + 5-FU/leucovorin
Receives: Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Irinotecan liposome
Cohort B Experimental Treatment ArmExperimentalSBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK
Receives: Biological: N-803; Drug: Aldoxorubicin HCl; Biological: PD-L1 t-haNK; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cyclophosphamide; Procedure: SBRT
Cohort C Experimental Treatment ArmExperimentalSBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK
Receives: Biological: N-803; Drug: Aldoxorubicin HCl; Biological: PD-L1 t-haNK; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cyclophosphamide; Procedure: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Response Criteria in Solid Tumors (RECIST) V1.1

    Measured: 8 weeks

Secondary outcomes (3)

  1. Objective response rate (ORR), Complete response (CR) rate, and Disease Control Rate (DCR)

    Response Criteria in Solid Tumors (RECIST) V1.1

    Measured: 2 years

  2. Overall Survival (OS)

    Measured: 2 years

  3. Quality of Life (QoL)

    Patient Reported Outcomes (PROs) using the Functional Assessment of Cancer Therapy - Hepatobiliary Cancer (FACT-Hep) Questionnaire

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start21 Jul 2020
  3. Primary completion13 Oct 2025
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
328 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390399
Sponsor's protocol ID
QUILT-88
Status last verified
Oct 2025
First submitted
7 May 2020
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-803, Aldoxorubicin HCl and PD-L1 t-haNK in people with Pancreatic Cancer, run by ImmunityBio, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04390399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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