It’s quite common in oncology to add cohorts to early phase trials to test different regimens, combinations, indications, etc. The protocol would need to be amended to specify unique inclusion/exclusion criteria by cohort, endpoints, etc. The ICF would also need to be amended.
I’ve done this in Phase 2 with different combinations and different indications. A cohort(s) that shows potential for clinical benefit could then be used to discuss Accelerated Approval with FDA.
Mark De Rosch, PhD, FRAPS
Original Message:
Sent: 3/4/2024 12:38:00 PM
From: Olga Peycheva
Subject: RE: Adding a combination study as a cohort to Phase 1 protocol (oncology)
Hello,
It depends on the objectives of your study. What the regulatory agencies do not want to see is 'never ending studies' where companies add cohort after cohort and at the end it is a completely different study.
Adding a new drug will lead to changes in your eligibility criteria (to consider the new drug), the analysis of the data, the treatment schedule, safety monitoring (to consider the combined AE, etc), etc. I believe this will require a new study.
Good luck with your study.
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/
United Kingdom
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Original Message:
Sent: 01-Mar-2024 07:33
From: Anonymous Member
Subject: Adding a combination study as a cohort to Phase 1 protocol (oncology)
This message was posted by a user wishing to remain anonymous
We have an ongoing Phase 1 study for an oncology Drug X. We are planning to do a combination study of Drug X with Keytruda. Will it be acceptable to FDA and EMA to add this combination study as a cohort to the Phase 1 protocol ? Previous experience to share and FDA/EMA guidelines on this topic are much appreciated.