Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Andrew Ko

Description

Summary

A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

Official Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Keywords

Pancreatic Adenocarcinoma Adenocarcinoma Pancreatic Neoplasms Paclitaxel Gemcitabine Oxaliplatin Atezolizumab Albumin-Bound Paclitaxel Fluorouracil Antibodies, Monoclonal Nab-Paclitaxel Leucovorin Cobimetinib PEGPH20 BL-8040 Atezolizumab + Cobimetinib Atezolizumab + PEGPH20 Atezolizumab + BL-8040

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
  • Disease progression during or within 6 months after treatment with one line of 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy in the metastatic setting
  • Life expectancy greater than or equal to (>/=3) months
  • Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing
  • Measurable disease (at least one target lesion) according to RECIST v1.1
  • Adequate hematologic and end-organ function test results
  • Tumor accessible for biopsy
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

You CAN'T join if...

  • Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases
  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Positive human immunodeficiency (HIV) test at screening or at any time prior to screening
  • Active hepatitis B or C virus infection or active tuberculosis
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death

Locations

  • Helen Diller Fam Comp Can Ctr accepting new patients
    San Francisco California 94158 United States
  • Oregon Health and Science University accepting new patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03193190
Phase
Phase 1/2
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
June 14, 2018