NCT04006119Phase 2Terminated

Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-08-05Actual

Enrollment · participants40Actual

Source updated2025-04-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Glioblastoma

Treatments or interventions studied

Ad-RTS-hIL-12Biological
VeledimexDrug
Cemiplimab-RwlcDrugAlso known as Libtayo, REGN2810

Primary outcomes · main study measures

Read the study measures

measure: Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.; description: Evaluation of adverse events as assessed by CTCAE v5.0 will be based on the incidence, intensity and type of adverse event. Safety evaluations included the observed incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of toxicity Grade \>3, TEAEs leading to treatment dose modification, discontinuation, and death. Drug-related TEAEs were also assessed.; timeFrame: 2.0 yrs; measure: Efficacy of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.; description: Overall Survival (OS) OS is defined as the duration of time from the first dose of study drug (i.e., cemiplimab at Day -7) to the date of death from any cause. Censoring will be considered as below: * Subjects who discontinue study will be censored at date of discontinuation. * Subjects who are lost to follow-up will be censored at last follow-up contact date. * If the subject has not died, the subject is censored if still alive up to 2 years from the first dose of study drug received.; timeFrame: 2.0 yrs

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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