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NCT00669734
Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery
Phase 1 trial testing Falimarev in Locally Advanced Pancreatic Adenocarcinoma in 18 participants. Participants enrolled and being followed up; not accepting new ones.
2 September 2021
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 February 2010 |
| Primary completion | 2 September 2021 |
| Estimated completion | 23 April 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Falimarev — full drug profile →
- Inalimarev — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Sargramostim (SARGRAMOSTIM) — full drug profile →
Conditions studied
- Locally Advanced Pancreatic Adenocarcinoma — all drugs for Locally Advanced Pancreatic Adenocarcinoma →
- Pancreatic Acinar Cell Carcinoma — all drugs for Pancreatic Acinar Cell Carcinoma →
- Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
- Stage III Pancreatic Cancer AJCC v6 and v7 — all drugs for Stage III Pancreatic Cancer AJCC v6 and v7 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Locally Advanced Pancreatic Adenocarcinoma or Pancreatic Acinar Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Viral vector-based gene therapies in the clinic.
Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258 -
Vaccine Therapies for Cancer: Then and Now.
Morse MA, Gwin WR, Mitchell DA. · · 2021 · cited 156× · PMID 33512679 · DOI 10.1007/s11523-020-00788-w -
From bench to bedside a comprehensive review of pancreatic cancer immunotherapy.
Kunk PR, Bauer TW, Slingluff CL, Rahma OE. · · 2016 · cited 86× · PMID 26981244 · DOI 10.1186/s40425-016-0119-z -
Emerging trends in the immunotherapy of pancreatic cancer.
Banerjee K, Kumar S, Ross KA, Gautam S, et al · · 2018 · cited 78× · PMID 29242097 · DOI 10.1016/j.canlet.2017.12.012 -
Trial watch: DNA vaccines for cancer therapy.
Senovilla L, Vacchelli E, Garcia P, Eggermont A, et al · · 2013 · cited 65× · PMID 23734328 · DOI 10.4161/onci.23803 -
Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine.
Huang X, Zhang G, Tang TY, Gao X, et al · · 2022 · cited 61× · PMID 36224645 · DOI 10.1186/s40779-022-00416-w -
Potential targets for pancreatic cancer immunotherapeutics.
Dodson LF, Hawkins WG, Goedegebuure P. · · 2011 · cited 59× · PMID 21463193 · DOI 10.2217/imt.11.10
Verify or expand the search:
- PubMed search for NCT00669734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Locally Advanced Pancreatic Adenocarcinoma
Currently open trials in the same condition.
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- NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
- NCT06861452 — Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcin · Phase 1, PHASE2 · recruiting
- NCT06850623 — Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer · Phase 2 · recruiting
- NCT07241663 — Surgery for Locally Unresectable Pancreatic Cancer · recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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- NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00669734 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 National Cancer Institute (NCI)
- Last refreshed: 24 October 2025
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/NCT00669734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing