Table 4.
Completed Vaccine-Based Trials in PDAC. * = data acquired from ASCO Publications; + = data acquired from PubMed or peer-reviewed publications; # = data acquired from ClinicalTrials.gov. The confidence interval of 95% is included in parentheses when available. HR: hazard ratio, SoC: standard of care.
| NCT | Phase | Intervention | Study Participant | Study Duration | Clinical Outcomes |
|---|---|---|---|---|---|
| NCT00084383 #, [94] | II | Single Arm: GVAX following SoC | n = 60, surgically resected PDAC | 2002–2006 | OS: 24.8 (21.2–31.6) DFS: 17.3 mo (14.6–22.8) |
| NCT00358566 #, [99] | III | Arm A: Gemcitabine Arm B: GV1001 (telomerase peptide vaccine) + gemcitabine |
n = 360, locally advanced or metastatic PDAC |
2006–2008 | Terminated, preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group. |
| NCT00425360 *, [100] | III | Arm A: Sargramostim (recombinant human GM-CSF) + GV1001 + capecitabine + gemcitabine hydrochloride concurrently Arm B: Capecitabine + gemcitabine hydrochloride with sequential GV1001 Arm C: Capecitabine + gemcitabine hydrochloride alone |
n = 1062 locally advanced or metastatic PDAC | 2006–2013 | OS: 8.4 mo (7.3–9.7) in Arm A vs. 6.9 mo (6.4–7.6) in Arm B vs. 7.9 mo (7.1–8.8) in Arm C |
| NCT00389610 #, [95] | II | Arm A: Previously vaccinated with GVAX, booster every 6 mo Arm B: GVAX naive, priming once a mo for 3 mo, every 6 mo afterwards |
n = 56 surgically resected PDAC | 2006–2022 | OS: 80.5 mo in Arm A (22.5 to 187.8), 30.7 mo in Arm B (19.3 to 40.7) DFS after 16 years: 109.5 mo in Arm A (5.59 to NA), 13.7 in Arm B (5.55 to 25.1) |
| NCT01417000 #, [96] | II | Arm A: CY + GVAX + CRS-207 (mesothelin-expressing LADD) Arm B: CY + GVAX |
n = 93 previously treated metastatic PDAC | 2011–2017 | OS: 6.26 mo in Arm A (4.47–9.40) vs. 4.07 mo in Arm B (3.32–5.42) |
| NCT02261714 #, [102] | I, II | Single Arm: TG01 (KRAS vaccine)/GM-CSF + gemcitabine | n = 32 surgically resected PDAC | 2012–2019 | OS: 33.3 mo (24.0–40.0) DFS: 16.1 mo (11.1–19.6) |
| NCT02004262 +, [97] | II | Arm A: CY + GVAX + CRS-207 Arm B: CRS-207 Arm C: SoC |
n = 213 previously treated metastatic PDAC | 2014–2016 | mOS: 3.7 mo in Arm A (2.9–5.3) vs. 5.4 mo in Arm B (4.2–6.4) vs. 4.6 mo in Arm C (4.2–5.7) HR: 1.17 (0.84–1.64) |
| NCT03190265 #, [98] | II | Arm A: CY + Nivolumab + Ipilimumab + GVAX + CRS-207 Arm B: Nivolumab + Ipilimumab + CRS-207 |
n = 61 previously treated metastatic PDAC |
2017–2023 | ORR 0.0% in Arm A, 7.4% in Arm B |
DFS: disease-free survival, GM-CSF: granulocyte macrophage colony-stimulating factor, GVAX: granulocyte-macrophage colony-stimulating factor gene-transduced tumor cell vaccine, HR: hazard ratio, KRAS: Kristen rat sarcoma viral oncogene homologue, LADD: live, attenuated, double-deleted Listeria monocytogenes, SoC: standard of care.