ArticleJournal for immunotherapy of cancer2013
A randomized pilot phase I study of modified carcinoembryonic antigen (CEA) peptide (CAP1-6D)/montanide/GM-CSF-vaccine in patients with pancreatic adenocarcinoma.
Article in Journal for immunotherapy of cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00203892 (A Randomized Pilot Phase II Study of Immunization With Modified CEA), which is not on this map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Pilot Phase II Study of Immunization With Modified CEA (CAP1-6D) Peptide In Patients With Locally Advanced Or Surgically Resected Adenocarcinoma of the Pancreas
Who cites it
26 citing papers in PubMed, 39 citations in OpenAlex.
- Targeting Carcinoembryonic Antigen with DNA Vaccination: On-Target Adverse Events Link with Immunologic and Clinical Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Trial
- Harnessing Vaccines in the Treatment of Solid Tumors: Advances, Challenges, and Future Directions.Vaccines · 2026Review
- Review
- Advances in Vaccine-Based Therapies for Pancreatic Cancer.Journal of gastrointestinal cancer · 2025Review
- The power and the promise of CAR-mediated cell immunotherapy for clinical application in pancreatic cancer.Journal of advanced research · 2025Review
- Review
- Circulating tumor-associated antigen-specific IFNγFrontiers in immunology · 2024Article
- Adjuvant properties of IFN-γ and GM-CSF in the scFv6.C4 DNA vaccine against CEA-expressing tumors.Gene therapy · 2023Article
- The Role of Immunotherapy in Pancreatic Cancer.Current oncology (Toronto, Ont.) · 2022Review
- A Brief Introduction to Current Cancer Gene Therapy.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Peptide-Based Therapeutics for Oncology.Pharmaceutical medicine · 2019Review
- A modified HLA-A*0201-restricted CTL epitope from human oncoprotein (hPEBP4) induces more efficient antitumor responses.Cellular & molecular immunology · 2018Article
- Methods for improving the immunogenicity and efficacy of cancer vaccines.Expert opinion on biological therapy · 2018Review
- Biomarker-Based Therapy in Pancreatic Ductal Adenocarcinoma: An Emerging Reality?Clinical cancer research : an official journal of the American Association for Cancer Research · 2018Review
- Emerging trends in the immunotherapy of pancreatic cancer.Cancer letters · 2018Review
- Immunotherapy and pancreatic cancer: unique challenges and potential opportunities.Therapeutic advances in medical oncology · 2018Review
- A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus poly-ICLC in early stage breast cancer.Journal for immunotherapy of cancer · 2017Article
- Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Strategies for Increasing Pancreatic Tumor Immunogenicity.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Review
- Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis?Surgery today · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundCEA is expressed in >90% of pancreatic cancers (PC) and may be an appropriate immunotherapy target. CEA is poorly immunogenic due to immune tolerance; CAP1-6D, an altered peptide ligand can help bypass tolerance. We conducted a pilot randomized phase I trial in PC patients to determine the peptide dose required to induce an optimal CD8(+) T cell response.
methodsPatients with a PS 0-1, HLA-A2+ and CEA-expressing, previously-treated PC were randomized to receive 10 μg (arm A), 100 μg (arm B) or 1000 μg (arm C) of CEA peptide emulsified in Montanide and GM-CSF, given every 2 weeks until disease progression.
resultsSixty-six patients were screened and 19 enrolled of whom 14 received at least 3 doses of the vaccine and thus evaluated for the primary immunologic endpoint. A median of 4 cycles (range 1-81) was delivered. Median and mean peak IFN-γ T cell response by ELISPOT (spots per 10(4) CD8(+) cells, Arm A/B/C) was 11/52/271 (A vs. C, p = 0.028) for medians and 37/148/248 (A vs. C, p = 0.032) for means. T cell responses developed or increased in 20%/60%/100% of pts in Arms A/B/C. Seven of the 19 patients remain alive at a minimum 32 months from trial initiation, including three with unresectable disease.
conclusionsThe T cell response in this randomized phase I trial was dose-dependent with the 1 mg CEA peptide dose eliciting the most robust T cell responses. A signal of clinical benefit was observed and no significant toxicity was noted. Further evaluation of 1 mg CEA peptide with stronger adjuvants, and/or combined with agents to overcome immune inhibitory pathways, may be warranted in PC pts.
trial registrationClinicalTrials.gov NCT00203892.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.