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QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

NCT03136406•ImmunityBio, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with pancreatic cancer who have progressed on or after previous Standard of Care first line therapy and chemotherapy.

Detailed Description

Treatment will be administered in two phases. Subjects will continue treatment until they experience progressive disease (PD) or experience unacceptable toxicity (not correctable with dose reduction), withdraw consent, or the investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) will enter phase 2 of the study. Subjects may remain on phase 2 of the study for up to 1 year. Treatment will continue throughout phase 2 until the subject experiences PD or unacceptable toxicity, withdraws consent, or the investigator feels it is no longer in the subject's best interest to continue treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years old.
•Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
•Histologically-confirmed pancreatic cancer with progression on or after SoC therapy.
•ECOG performance status of 0 to 2.
•Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
•Must have a recent tumor biopsy specimen following the conclusion of the most recent anti-cancer treatment. If a historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
•Must be willing to provide blood samples for exploratory analyses.
•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 with child-bearing potential and non-sterile males.

Exclusion Criteria

•History of persistent grade 2 or higher (CTCAE Version 4.03) hematological toxicity resulting from previous therapy.
•History of other active malignancies or brain metastasis except: controlled basal cell carcinoma; prior history of in situ cancer (eg, breast, melanoma, cervical); prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy) and with undetectable prostate-specific antigen (PSA) (\< 0.2 ng/mL); bulky (≥ 1.5 cm) disease with metastasis in the central hilar area of the chest and involving the pulmonary vasculature. Subjects with a history of another malignancy must have \> 5 years without evidence of disease.
•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).
•History of organ transplant requiring immunosuppression.
•History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
•Requires whole blood transfusion to meet eligibility criteria.
•Inadequate organ function, evidenced by the following laboratory results:
•* White blood cell (WBC) count \< 3,500 cells/mm3
•* Absolute neutrophil count \< 1,500 cells/mm3.
+17 more criteria

Locations (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

Key Dates

Start Date

August 11, 2017

Primary Completion Date

November 22, 2017

Completion Date

November 1, 2019

Last Updated

June 11, 2024

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

Cyclophosphamide

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

5-Fluorouracil

DRUG

Leucovorin

DRUG

nab-paclitaxel

DRUG

bevacizumab

BIOLOGICAL

avelumab

BIOLOGICAL

ALT-803

BIOLOGICAL

aNK for Infusion

BIOLOGICAL

ETBX-011

BIOLOGICAL

GI-4000

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy

Inclusion Criteria

Exclusion Criteria

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