MEDI0680 with Durvalumab vs Nivolumab Alone
Research type
Research Study
Full title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies
IRAS ID
225542
Contact name
Gemma Sheppard
Contact email
Sponsor organisation
MedImmune, LLC, a wholly-owned subsidiary of AstraZeneca PLC
Eudract number
2016-000323-43
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
This is a multicentre, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies.
MEDI0680, durvalumab and nivolumab are monoclonal antibodies that are similar to antibodies that are made by the human body. Antibodies are natural proteins made by our immune system that bind to other proteins and molecules to fight infection and its ill effects. Durvalumab binds to the PD-L1 protein in the body and may prevent cancer growth by helping certain blood cells of the immune system eliminate the tumour. MEDI0680 and nivolumab work to block PD-1 from attaching to the PD-L1 and PD-L2 proteins within the tumour thereby allowing the T cells and the body’s immune system to attack the tumour. MEDI0680 may also work by making the T cells kill the tumours better.Up to 96 people will be asked to participate in the study in up to 80 clinical research sites globally.
The study includes 2 phases, dose-escalation and dose-expansion. In the dose-escalation phase, Participants with selected solid tumours will receive MEDI0680/durvalumab combination therapy. In the dose-expansion phase, participants with clear cell Renal Cell Carcinoma (ccRCC) will receive either (1)MEDI0680/durvalumab combination therapy or (2)nivolumab monotherapy.
The UK is only taking part in the dose expansion phase.
The dose-expansion phase will begin after the dose-escalation phase. Participants with ccRCC will be randomized in a 2:1 ratio to 1 of 2 treatment arms: (1) MEDI0680/durvalumab combination therapy or (2) nivolumab monotherapy.
Participants may receive the study drug(s) for up to 2 years.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0340
Date of REC Opinion
31 Oct 2017
REC opinion
Further Information Favourable Opinion