A Phase 2 Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal
Research type
Research Study
Full title
Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy
IRAS ID
253346
Contact name
Sheela Rao
Contact email
Sponsor organisation
Incyte Biosciences Limited
Eudract number
2018-002070-51
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 24 days
Research summary
This study is an open-label, single-group, multicentre, Phase 2 study that will enroll patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on a standard-of-care platinum-based chemotherapy regimen. The study will be conducted at specialist oncology units.
Following a screening period during which their eligibility is confirmed, male or female participants will be administered INCMGA00012 at the recommended Phase 2 dose of 500 mg intravenously every four weeks for up to two years in the absence of clinical disease progression, intolerability, death, withdrawal of consent, loss to follow-up, or premature discontinuation for any other reason.
While on study treatment and follow-up, patients will undergo the following safety assessments: medical assessment, physical examination, vital signs, electrocardiogram (ECG), routine laboratory tests and recording of adverse events.
The efficacy of INCMGA0012 will be assessed through radiographic imaging, while its distribution around and elimination from the body (pharmacokinetics) will be measured through blood sampling. Further blood samples will be drawn to measure the action of INCMGA0012 on various tissues. Patients who provide additional optional written informed consent will also undergo tumour biopsies.
Approximately 81 participants will be enrolled globally.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/2067
Date of REC Opinion
9 Jan 2019
REC opinion
Further Information Favourable Opinion