CA025-006: Phase 2 Cabiralizumab & Nivolumab in Pancreatic Cancer
Research type
Research Study
Full title
A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without chemotherapy in Patients with Advanced Pancreatic Cancer
IRAS ID
247851
Contact name
Jeff Evans
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-000339-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 134,940
Duration of Study in the UK
2 years, 8 months, 25 days
Research summary
Adenocarcinoma of the pancreas has a poor prognosis because it is generally detected at a late stage and the existing chemotherapies are not very efficient, which are the cause of a high mortality. The progression after the first treatment is frequently observed in patients with advanced pancreatic cancer and the available chemotherapies for such cancer are limited. Therefore, there is a significant need to develop alternative therapy approaches for the treatment of advanced pancreatic cancer.
Immunotherapy is a therapy based on the stimulation of the body's own immune system to attack cancer cells. The investigational drugs cabiralizumab and nivolumab are immunotherapy agents, which help the immune system to recognise and kill cancer cells.
The combination of two immunotherapy agents could lead to a better effect to kill cancer cells and the addition of chemotherapy (standard of care) could produce a stronger response. Clinical trials using immunotherapy and chemotherapy show encouraging results.
The eligible patients will receive one of the following treatments:
Group A: Chemotherapy, standard of care alone (Gemcitabine based chemotherapy or 5- Fluouracil based chemotherapy)
Group B: Combination of Cabiralizumab and Nivolumab
Group C: Combination with Gemcitabine based chemotherapy
Group D: Combination with 5- Fluouracil based chemotherapy
All treatments will be given intravenously with the study drugs, cabiralizumab and nivolumab given every 4 weeks.Patients will undergo during the study procedures such as tumour biopsy, CT/MRI scans and blood tests for routine safety and study specific testing. Patients will also be required to complete questionnaires throughout the study to assess their quality of life.
Patients can remain in the study until they have serious side effects, their cancer has worsened or they withdraw their consent.
There will be about 160 subjects treated in the study including approximately 6 from th
The purpose of the study is to determine if the combination of cabiralizumab and nivolumab with or without chemotherapy improves survival in patients with advanced pancreatic cancer that became worse or spread in the body during or after the first treatment. The study will also assess the safety, effectiveness and tolerability of the combination with and without chemotherapy.e UK. The study is expected to last around 14 months.REC name
West of Scotland REC 1
REC reference
18/WS/0119
Date of REC Opinion
13 Aug 2018
REC opinion
Further Information Favourable Opinion