Study of Pamrevlumab or Placebo with chemotherapy in Pancreatic Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer
IRAS ID
272435
Contact name
Khurum Khan
Contact email
Sponsor organisation
FibroGen, Inc.
Eudract number
2019-001925-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
011952, IND Number
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Pancreatic cancer is an aggressive (grows quickly) cancer which does not respond very well to chemotherapy treatment alone. Removal of the tumour at diagnosis is the best way to improve overall survival however most tumours cannot be removed completely by surgery alone. Neoadjuvant therapy (one treatment followed by another treatment) may improve the chances of overall survival following surgical removal of a tumour.
The purpose of this study is to evaluate whether pamrevlumab, given in combination with the currently approved chemotherapy treatment (gemcitabine and nab-paclitaxel) is effective and safe in the treatment of patients with locally advanced unresectable (cannot be completely removed by surgery) pancreatic cancer. Pamrevlumab works by interfering with connective tissue growth factor (CTGF) which is a protein that the body normally produces. Sometimes the body produces too much CTGF which may help tumours grow or spread. Pamrevlumab is a protein medication known as a human monoclonal antibody which is similar to the antibodies that the immune system produces to fight infections.Participants will be randomly assigned (like flipping a coin) to 1 of 2 treatment groups which include treatment with the currently approved chemotherapy treatments in combination with pamrevlumab or placebo.
The treatment phase of the study will consist of six 28-day cycles. Participants will receive chemotherapy treatment once a week for three weeks followed by a week of no treatment for each cycle. Participants will also receive pamrevlumab or placebo every week for the first three weeks of treatment and then every other week for each cycle of treatment. Once the participant has received all the treatments and has had a safety follow up visit, relevant information will be sent to a central review board who will recommend whether or not the participant is eligible to undergo surgery to attempt removal of the tumour.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0018
Date of REC Opinion
11 Mar 2020
REC opinion
Further Information Favourable Opinion