*CA045-020 Bempegaldesleukin + Nivo in Paediatric Malignancies
Research type
Research Study
Full title
Phase 1/2 Study of Bempegaldesleukin in Combination with Nivolumab in Children, Adolescents, and Young Adults with Recurrent or Refractory Malignancies (PIVOT IO 020)
IRAS ID
1003686
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2020-000854-85
Clinicaltrials.gov Identifier
Research summary
This is a multicentre early phase study of 2 study drugs called Nivolumab (Nivo) and Bempegaldesleukin (Bempeg) given together in patients up to the age of 30, with cancers that don’t respond to treatment, or that have returned after treatment, or without a treatment available.
Nivolumab and Bempeg are types of immunotherapy drugs that stimulate the body’s immune system to attack cancer cells.
This study assesses the safety of Bempeg with Nivo in children, teenagers, young adults; also if the 2 study drugs delay the progression of untreatable cancers.
Up to 228 patients will take part globally in this study, with 18 of them in the UK.
The study is in 2 parts: Part A will check the safety of Bempeg with Nivo. Part B will check the efficacy of Bempeg with Nivo in various types of cancers.
There are 3 study phases: Screening, Treatment, Follow-up. During Treatment, patients will receive Nivolumab and Bempeg every 3 weeks. Patients will receive the drugs into a vein. Both the patients and the study doctor will know the doses that patients will receive.
Bempeg can drop the blood pressure. To avoid this, patients will receive salty water in a vein before their treatment. For the 3 days following the Bempeg dose, patients should also drink between 0.5 and 2 litres of liquid every day, depending on their age or weight. They will also refrain from doing anything that makes them sweat, such as physical exercise or going to the sauna. Patients will also have an examination of their heart to check that they can take part in the study.
During their study participation, patients will have physical examinations (including vital signs, temperature, weight), scans, up to 3 biopsies, questionnaires, blood samples for safety and for study-specific tests. Patients will receive the drugs for up to 2 years, or until they withdraw their consent to their study treatment; they no longer tolerate the study drugs; or their cancer progresses.
The study is paid by Bristol Myers Squibb.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0277
Date of REC Opinion
18 Mar 2022
REC opinion
Further Information Favourable Opinion