Number of Participants With Adverse Events
Primary
· 30 days after last dose, up to 2 years
| Group | Value | 95% CI |
|---|---|---|
| NANT Pancreatic Cancer Vaccine | 3 |
Last reviewed · How we verify
NCT03136406
QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy
Terminated
Phase 1, PHASE2
Results posted
Last updated 11 June 2024
What this trial tests
Phase 1, PHASE2 trial testing Cyclophosphamide in Pancreatic Cancer in 3 participants. Terminated before completion.
Timeline
11 August 2017
Primary endpoint
22 November 2017
22 November 2017
1 November 2019
Quick facts
| Lead sponsor | ImmunityBio, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 11 August 2017 |
| Primary completion | 22 November 2017 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
- 5-Fluorouracil
- Leucovorin (leucovorin) — full drug profile →
- nab-paclitaxel
- bevacizumab
- avelumab (avelumab) — full drug profile →
- ALT-803
- aNK for Infusion
- ETBX-011
- GI-4000
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
Sponsor
ImmunityBio, Inc. — full company profile →
Who can join
18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days after last dose, up to 2 years or until resolution or stabilization for nonserious grade 3 or 4 AEs and SAEs, whichever is longer.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NANT Pancreatic Cancer Vaccine
Serious: 1/3 (33%)
Deaths: 1/3
Serious adverse events (1 terms)
| Reaction | System | NANT Pancreatic Cancer Vac… |
|---|---|---|
| Injection site erythema | General disorders | — |
Other adverse events (43 terms — click to expand)
| Reaction | System | NANT Pancreatic Cancer Vac… |
|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Injection site erythema | General disorders | — |
| Injection site reaction | General disorders | — |
| Pyrexia | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Fatigue | General disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Neuropathy peripheral | Nervous system disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Weight decreased | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Lymph node pain | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Injection site pain | General disorders | — |
| Injection site swelling | General disorders | — |
| Pain | General disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| INFUSION-RELATED REACTION - RIGORS | Investigations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Oral discomfort | Gastrointestinal disorders | — |
| Mucosal inflammation | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Injection site erythema.
Data from ClinicalTrials.gov NCT03136406 adverse events section.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x -
The NK cell-cancer cycle: advances and new challenges in NK cell-based immunotherapies.
Bald T, Krummel MF, Smyth MJ, Barry KC. · · 2020 · cited 388× · PMID 32690952 · DOI 10.1038/s41590-020-0728-z -
Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038 -
Current advances and outlooks in immunotherapy for pancreatic ductal adenocarcinoma.
Fan JQ, Wang MF, Chen HL, Shang D, et al · · 2020 · cited 179× · PMID 32061257 · DOI 10.1186/s12943-020-01151-3 -
Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5 -
Mutations in key driver genes of pancreatic cancer: molecularly targeted therapies and other clinical implications.
Hu HF, Ye Z, Qin Y, Xu XW, et al · · 2021 · cited 116× · PMID 33574569 · DOI 10.1038/s41401-020-00584-2 -
Normalization of the tumor microenvironment by harnessing vascular and immune modulation to achieve enhanced cancer therapy.
Choi Y, Jung K. · · 2023 · cited 100× · PMID 37907742 · DOI 10.1038/s12276-023-01114-w -
From Immunogenic Cell Death to Immunogenic Modulation: Select Chemotherapy Regimens Induce a Spectrum of Immune-Enhancing Activities in the Tumor Microenvironment.
Fabian KP, Wolfson B, Hodge JW. · · 2021 · cited 77× · PMID 34497771 · DOI 10.3389/fonc.2021.728018
Verify or expand the search:
- PubMed search for NCT03136406
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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- NCT07492875 — Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia · Phase 3 · not yet recruiting
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- NCT07125872 — Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03136406 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ImmunityBio, Inc.
- Last refreshed: 11 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03136406.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing