A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

Cell Genesys50 enrolled

Overview

To evaluate the safety and effectiveness of CG8020 and CG2505.

To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Cancer Nonresectable Pancreatic Cancer

Interventions

CG 8020 and CG 2505BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma * Chemotherapy naïve or chemotherapy experienced pancreatic cancer Exclusion Criteria: * Prior cancer vaccines or gene therapy * History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis) * History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

Locations (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

US Oncology

Dallas, Texas, United States

Outcomes

Primary Outcomes

Safety

Efficacy measured by clinical benefit response

Progression-free survivial

Overall survival

Data from ClinicalTrials.gov

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