MS201781-0031, Phase 1b, open-label study in advanced solid tumours
Research type
Research Study
Full title
A Phase Ib Open Label, Dose Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors
IRAS ID
239967
Contact name
Robert Jones
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2017-002212-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
131184, IND
Duration of Study in the UK
2 years, 6 months, 14 days
Research summary
The main purpose of this research study is to assess how effective the study drugs (avelumab and NHS-IL12) are against certain solid tumours. It will also collect more information on how safe and well-tolerated the combined study drugs are.
This study has two parts; Part A, Dose Escalation - to find the highest dose of the study drug that can be used safely and that does not cause unacceptable side effects, and Part B, Expansion Cohorts - to test how safe and effective the study drug combination is. Part A of the study is on-going in the USA only and will establish the best dose for NHS-IL12 in combination with avelumab. After the best NHS-IL12 dose is confirmed in Part A, Part B will run several expansion cohorts in selected types of tumour. Approximately 140 subjects will be enrolled across the 4 expansion cohorts: 40 subjects per cohort in the non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC) indications and 30 subjects per cohort in the colorectal carcinoma (CRC) and renal cell carcinoma (RCC) indications. The UC and RCC cohorts will be the first to open with the NSCLC and CRC cohorts starting at a later date to be determined by the Sponsor. The NSCLC cohort is not being conducted in the UK.
The study comprises of a Screening Period (up to 28 days), a Treatment Period consisting of 28-day Cycles (lasting up to 24 months, depending on the participants response to treatment) and a Follow-up Period (lasting up to 1 year after the last participant leaves the study).
The study will be conducted at 65 study centres in 10 or more countries from around the world and the study is expected to last until 2020.
REC name
Wales REC 1
REC reference
18/WA/0085
Date of REC Opinion
15 May 2018
REC opinion
Further Information Favourable Opinion