A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas

Roche

Status and phase: Completed; Phase 1

Conditions: Pancreatic Neoplasm

Treatments: Drug: chemotherapy; Biological: monoclonal antibody

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00711191

A5021005

Details and patient eligibility

About

This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1st-line surgically incurable cancer of the pancreas
• ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion criteria

• Previous systemic therapy for pancreas cancer
• History of cancer-associated blood clots
• History of autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

single arm

Experimental group

Treatment:

Drug: chemotherapy

Biological: monoclonal antibody