GVAX leukemia vaccine / Dana-Farber Cancer Institute, Novartis - LARVOL DELTA

A phase I trial of vaccination with lethally irradiated lymphoma cells admixed with granulocyte-macrophage colony-stimulating factor secreting K562 cells for the treatment of follicular lymphoma. (PubMed, Leuk Lymphoma) - P1 | "Vaccines contained dose levels of 5 × 106 or 1 × 107 GM-K562 cells admixed with autologous tumor cells at doses ranging from 1 × 105 to 5 × 107.Correlative studies did not demonstrate a significant immune response as assessed by delayed-type hypersensitivity reactions, B and T cell subsets, and natural killer cell subsets. Future vaccine studies should focus on identifying lymphoma-specific immunogenic proteins and modifying the vaccine immune adjuvant."

Journal • P1 data • Follicular Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Oncology

Results from a phase 2b, randomized, multicenter study of GVAX pancreas and CRS-207 compared to chemotherapy in adults with previously-treated metastatic pancreatic adenocarcinoma (ECLIPSE Study). (ASCO-GI 2017) - P2b; "Low-dose cyclophosphamide (CY) is administered with GVAX to inhibit regulatory T cells. The combination of CY/GVAX + CRS-207 did not show a survival benefit over chemotherapy in patients with previously-treated mPDA, although survival of patients receiving CRS-207 alone appeared similar to chemotherapy. The regimens were well tolerated with no new significant safety findings. The high dropout rate in the chemotherapy arm demonstrates a potential challenge for conventional controls in immunotherapy trials."

Clinical • Biliary Cancer • Biosimilar • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

GVAX vs. Placebo for MDS/AML After Allo HSCT (clinicaltrials.gov) - P2 | N=123 | Terminated | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jan 2035 ➔ Nov 2021 | Active, not recruiting ➔ Terminated; Recommendation by the Data and Safety Monitoring Board due to efficacy concerns

Trial completion date • Trial termination • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

GM-CSF secreting leukemia cell vaccination for MDS/AML after allogeneic HSCT: a randomized double blinded phase 2 trial. (PubMed, Blood Adv) - P2 | "GVHD prophylaxis included tacrolimus and methotrexate. GVAX does not improve survival after HSCT for MDS/AML. (Clinicaltrials.gov identifier: NCT01773395)."

Clinical • Journal • P2 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CSF2

GVAX vs. Placebo for MDS/AML After Allo HSCT (clinicaltrials.gov) - P2; N=123; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial primary completion date: Jun 2021 ➔ Dec 2020

Clinical • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

GVAX vs. Placebo for MDS/AML After Allo HSCT (clinicaltrials.gov) - P2; N=123; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2033 ➔ Jan 2035

Clinical • Enrollment closed • Trial completion date • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

GVAX vs. Placebo for MDS/AML After Allo HSCT (clinicaltrials.gov) - P2; N=152; Recruiting; Sponsor: Dana-Farber Cancer Institute; Trial primary completion date: Jul 2019 ➔ Jun 2021

Clinical • Trial primary completion date