Nivolumab Monotherapy vs Nivolumab combined therapy in Solid Tumors
Research type
Research Study
Full title
A Phase 1/2 Open-label study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors.
IRAS ID
139389
Contact name
Jeff Evans
Contact email
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2013-002844-10
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, phase 1/2 study involving an investigational drug called Nivolumab given alone or in combination with Ipilimumab, in patients with either Triple Negative Breast Cancer (TNBC), Gastric Cancer, Pancreatic Adenocarcinoma or Small Cell Lung Cancer (SCLC). The purpose of this study is to determine if there is clinical activity with Nivolumab or Nivolumab combined with Ipilimumab in patients that have progressed after 1st line treatment or have refused 1st line treatment.
For TNBC, Gastric and Pancreatic cancer there is no universally agreed upon standard of care. For SCLC of the patients with Limited Stage Disease 80% will have disease progression therefore survival rates are quite low.
Nivolumab and Ipilimumab are designed to work by helping the body’s own immune system attack the cancer cells. Ipilimumab is already approved for use in advanced melanoma in Europe.
Approximately 160 patients will take part globally with approximately 22 coming from the UK. The study is sponsored by Bristol Myers Squibb. Following a screening period, eligible patients will receive either nivolumab,
or Nivolumab and Ipilimumab in combination. Patients and doctors will know what medication they have been assigned to. All medications are given intravenously (through your vein). Patients will undergo the following study procedures:
tumour biopsy, CT/MRI scans, physical exams, vital signs such as blood pressure, height, weight, body temperature, oxygen levels and bloods for routine safety testing and study specific testing. Participants will also be required to complete a questionnaire at regular intervals throughout the study.
Patients can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. At the conclusion of the study patients who continue to gain clinical benefit may be eligible to continue to receive study drug via an extension to the study.REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0541
Date of REC Opinion
11 Nov 2013
REC opinion
Further Information Favourable Opinion