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NCT00669734

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery

Active, enrolled Phase 1 Last updated 24 October 2025
What this trial tests

Phase 1 trial testing Falimarev in Locally Advanced Pancreatic Adenocarcinoma in 18 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 February 2010
Primary endpoint
2 September 2021
23 April 2026

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date1 February 2010
Primary completion2 September 2021
Estimated completion23 April 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. Viral vector-based gene therapies in the clinic.
    Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. Potential targets for pancreatic cancer immunotherapeutics.
    Dodson LF, Hawkins WG, Goedegebuure P. · · 2011 · cited 59× · PMID 21463193 · DOI 10.2217/imt.11.10

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Other recruiting trials for Locally Advanced Pancreatic Adenocarcinoma

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Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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