Table 2:
Completed Immunotherapy Trials
| Title | Start Date | Phase | Target | Primary Endpoint | Number Enrolled | Status | Clinical Trial Registry Number | Result |
|---|---|---|---|---|---|---|---|---|
| Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma of the Pancreas | 2002 | II | GVAX | OS and DFS | 60 | Completed | NCT00084383 | Median DFS 17.3 months (95% CI, 14.6–22.8) 75 Median OS 24.8 months (95% CI, 21.2–31.6) |
| A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Cetuximab for the Treatment of Advanced Pancreatic Adenocarcinoma | 2005 | II | GVAX + EGFR | Safety (Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population) | 60 | Completed | NCT00305760 | Serious Adverse events in 20% of participants 76 |
| A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer | 2008 | I | CD40 | Number of Participants With Dose Limiting Toxicities | 22 | Completed | NCT00711191 | Serious Adverse events in 9/22 participants 36,77 |
| Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer | 2011 | II | Cy/GVAX + CRS-207 | OS | 93 | Completed | NCT01417000 | OS 6.1 months75 |
| Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-mesothelin Gene Engineered Lymphocytes | 2012 | I | CAR-T: anti-mesothelin | ORR Serious and Non-serious Adverse Events |
15 | Terminated | NCT01583686 | ORR 0% Study did not proceed to Phase II. 78 |
| Phase IB Study of FOLFIRINOX Plus PF-04136309 in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma | 2012 | Ib | CCR2 | RP2D and DLT | 47 | Completed | NCT01413022 | Combination was safe and tolerable |
| A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer | 2013 | II | CTLA4+ GVAX | OS | 83 | Completed | NCT01896869 | No Results Posted-Completed 5/201979 |
| Phase I Clinical Trial of Autologous Mesothelin Re-directed T Cells in Patients With Chemotherapy Refractory Metastatic Pancreatic Cancer | 2013 | I | CAR-T: anti-mesothelin | Adverse Events as a Measure of Safety and Tolerability. | 16 | Completed | NCT01897415 | No Results Posted-Completed 3/201780 |
| A Phase IIB, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS 207 Compared to Chemotherapy or to CRS-207 Alone in Adults With Previously-Treated Metastatic Pancreatic Adenocarcinoma | 2014 | IIB | GVAX/CRS-207 | OS | 303 | Completed | NCT02004262 | The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy.37 |
| Phase I Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma | 2015 | I | CD40 | Adverse Events as a Measure of Safety and Tolerability | 10 | Completed | NCT02588443 | No Results Posted-Completed 11/201881 |
| A Multi-Center Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Durvalumab (MEDI4736), in Subjects With Relapsed or Refractory Solid Tumors | 2015 | I/II | BTK/PD1 | Adverse Events ORR |
44 | Completed | NCT02403271 | 2% ORR82 |
| Pilot Study of Autologous T-cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer | 2015 | I | CAR-T: anti-mesothelin, anti-CD19 | Safety | 4 | Terminated | NCT02465983 | Terminated. No results posted. 83 |
| Phase Ib Trial of CAR-T Hepatic Artery Infusions Followed by Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Sir-Spheres for CEA-Expressing Liver Metastases | 2015 | I | Yttrium-90 Sir-Spheres with anti-CEA CAR-T | Safety as Measured by Number of Participants with AE | 8 | Completed | NCT02416466 | No Results Posted-Completed 6/201884 |
| Phase 1B/2 Study Of PF-04136309 In Combination With Gemcitabine and Nab-Paclitaxel in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma | 2016 | Ib/II | CCR2 | Number of Participants with DLT, Number of Participants With Treatment-Emergent AE, PFS |
22 | Terminated | NCT02732938 | ORR of 23.8%. High incidence of pulmonary toxicity (24%), 3 of 17 subjects (17.6%) had DLT.85 |
| A Dose Escalation Phase I Study With an Extension Part Evaluating the Safety and Activity of an Anti-PDL1 Antibody (Durvalumab) Combined With a Small Molecule CSF-1R Tyrosine Kinase Inhibitor (Pexidartinib) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers | 2016 | I | PDL-1, CSF1R | DLT, ORR |
48 | Completed | NCT02777710 | No Results Posted-Completed 12/201986 |
| Phase IB Study Investigating the Tolerability, Immunomodulatory Impacts and, Therapeutic Correlates of the Novel Toll-like Receptor 8 Agonist Motolimod Plus Cyclophosphamide Treatment of Advanced Solid Tumors | 2016 | I | TLR-8, MDSC | Change in pharmacodynamics after drug administration | 4 | Terminated | NCT02650635 | Permanently closed per sponsor’s request87 |
Legend: PFS = Progression free survival, Maximum tolerated dose (MTD), ORR= overall response rate, CR= complete response, OS= overall survival, RP2D= recommended phase II dose, DFS= Disease Free survival, DLT= Dose limiting toxicity, AE= Adverse events