ML40108 v.2.0
Research type
Research Study
Full title
A MULTICENTER STUDY TO EXPLORE THE MECHANISM OF ACQUIRED IMMUNE ESCAPE IN PATIENTS WITH METASTATIC CANCER PROGRESSING ON CHECKPOINT INHIBITOR THERAPY
IRAS ID
254200
Contact name
Thomas Bartholomew Powles
Contact email
Sponsor organisation
Genentech, Inc
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The objective of this exploratory biopsy study is to identify potential mechanisms of acquired immune escape to checkpoint inhibitor (CPI) therapy.Immune escape is the ability, by one of several mechanisms, for cancer cells to avoid elimination, and therefore, interrupt the patient’s response to treatment. This question is important to increase the knowledge and understanding of disease biology, and determine how immune escape starts. There is overall limited data about acquired immune escape across cancer types, which this study hopes to help increase.
This will be accomplished by comparing baseline and at-progression biopsy tissue samples from patients who have shown a clinical benefit, or response, from CPI treatment of metastatic cancer (solid tumors) or hematologic malignancies (cancers of the blood), and who then progress.Samples will be analyzed to locate mutations associated with immune escape, where possible.
Patient will only be enroled once they discontinued the CPI therapy and will not be receiving any investigational treatment as part of this study
Prospective patients must have received CPI therapy for metastatic cancer or hematologic malignancies, must have achieved a documented response (Partial Response, Complete Response, or long Stable Disease as defined by RECIST criteria), and be eligible for an at-progression biopsy.
Retrospective enrolment of patients who progressed on CPI therapy after documented response and for whom an at-progression biopsy is already available, is also possible. These patients should have also achieved a documented response as indicated above. Patients can be enroled if they received marketed CPI therapy or participated in a Roche/Genentech CPI trial. Patients taking CPI combination therapies with chemotherapy are not permitted, however immunotherapy combinations are allowed. A baseline archival biopsy sample is required prior to beginning the CPI therapy. Patients will participate in the study from time of consent until the collection of the at-progression biopsy, which can vary between prospective and retrospective patients.REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0499
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion