Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02574260
Brief Summary:
The primary objective of this extension study was to further assess the safety and tolerability of talimogene laherparepvec. Secondary objectives were to assess objective tumor response rate and survival.
Detailed Description:
This was an extension study to the multicenter, open-label, phase 2 Study 002/03 (NCT00289016). Participants who had received the maximum 24 treatments under Study 002/03 and met the inclusion and exclusion criteria were eligible to enroll.
Participants continued to receive talimogene laherparepvec until discontinuation criteria were met. The discontinuation criteria were complete response, clinically significant progressive disease that rendered further dosing futile, receipt of 24 treatments or 12 months on treatment (whichever was longer), occurrence of an unacceptable toxicity, death, investigator determination that other treatment was warranted, or another criterion for withdrawal from treatment (participant request, noncompliance with study procedures, or sponsor request).
Study:
NCT02574260
Study Brief:
Protocol Section:
NCT02574260