A Phase 1 Study of Durvalumab & IPH2201 in Adults with advance tumours
Research type
Research Study
Full title
A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects with Select Advanced Solid Tumors
IRAS ID
213269
Contact name
Susana Banerjee
Contact email
Sponsor organisation
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
Eudract number
2016-000662-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This research study is designed to see if the experimental combination treatment of DURVALUMAB and IPH2201, the study medications, are safe and tolerable in treating various solid tumour cancers. DURVALUMAB and IPH2201 are being investigated as cancer drugs that may help the body’s immune (protective) system destroy cancer cells. This study will occur in two parts, Part 1 (dose-escalation phase) and Part 2 (dose-expansion phase). This application is only in reference to part 2. The main purpose of Part 1 is to determine the doses and dosing schedule of both DURVALUMAB and IPH2201 that are safe and tolerable when given together. Part 2 of the study will begin after the Sponsor determines the safe and tolerable doses and dosing schedule from Part 1 that will be further investigated in Part 2. In Part 2, only participants with CRC, ovarian cancer, endometrial cancer and NSCLC will be enrolled. There will be approximately 40 participants with each type of cancer enrolled. The main purpose of Part 2 is to continue to assess the safety and tolerability of the doses and dosing schedule selected from Part 1. During the treatment period, DURVALUMAB will be administered every 4 weeks and IPH2201 will be administered either every 2 or 4 weeks (depending on when the participant enrolled into the study) Participants will receive DURVALUMAB and IPH2201 until their cancer gets worse, they experience a significant side effect and it would be unsafe for them to continue treatment, or if they decide to stop treatment for other reasons.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/2137
Date of REC Opinion
18 Jan 2017
REC opinion
Further Information Favourable Opinion