Trial · NCT07908147
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Rapid Molecular Profiling and Matched Targeted Therapy | From enrollment to initiation of chemoradiation (pre-treatment period). | To assess the feasibility of performing rapid molecular profiling before chemoradiation and initiating matched targeted therapy in patients with actionable molecular alterations. |
| Secondary | Number and Percentage of Participants Experiencing Adverse Events by CTCAE Grade | From Cycle 1 Day 1 (each cycle is 28 days) until 30 days after the end of study treatment. | Toxicity of treatment with plixorafenib, cadonilimab, or larotrectinib will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. The number and percentage of participants experiencing adverse events will be summarized by CTCAE severity grade and, where applicable, relationship to study treatment. |
| Secondary | Efficacy of Induction Targeted Therapy in Newly Diagnosed Glioblastoma | From Cycle 1 Day 1 (each cycle is 28 days) until the commencement of the next anti-cancer intervention or death from any cause, whichever occurs first. | To assess the efficacy of induction treatment with plixorafenib, cadonilimab, or larotrectinib in patients with newly diagnosed glioblastoma and eligible molecular profiles, measured by progression-free survival (PFS) and time to next intervention (TTNI) |
| Secondary | Change in Quality of Life Scores as Assessed by the EORTC QLQ-C30 Questionarrie | From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months. | The effect of upfront treatment with plixorafenib, cadonilimab, or larotrectinib on quality of life in patients with newly diagnosed glioblastoma with eligible molecular phenotypes will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be calculated according to the questionnaire scoring manual. |
| Secondary | Change in Learning and Memory Scores as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) | At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis. | Neurocognitive function in patients with newly diagnosed glioblastoma and eligible molecular profiles will be assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R), which evaluates verbal learning and memory. |
| Secondary | Change in Quality of Life Scores as Assessed by the EORTC QLQ-BN20 Questionarrie | From Cycle 1 Day 1 (each cycle is 28 days) through the end of treatment (EOT), up to 12 months. | The effect of upfront treatment with plixorafenib, cadonilimab, or larotrectinib on brain tumour-specific quality of life in patients with newly diagnosed glioblastoma with eligible molecular phenotypes will be assessed using the European Organisation for Research and Treatment of Cancer Brain Neoplasm Module (EORTC QLQ-BN20). Scores will be calculated according to the questionnaire scoring manual. |
| Secondary | Change in Attention and Working Memory Scores as Assessed by the Wechsler Adult Intelligence Scale Digit Span Test | At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis. | Attention and working memory will be assessed using the Digit Span subtest of the Wechsler Adult Intelligence Scale (WAIS). Changes in scores from baseline will be summarized over the assessment period. |
| Secondary | Change in Processing Speed as Assessed by Trail Making Test Part A | At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis. | Processing speed will be assessed using Trail Making Test Part A. Changes in test performance from baseline will be summarized over the assessment period. |
| Secondary | Change in Executive Function as Assessed by Verbal Fluency and Trail Making Test Part B | At baseline (before initiation of study drugs or standard chemoradiation) and every 12 months thereafter, up to 5 years after initial surgery at diagnosis. | Executive function will be assessed using verbal fluency testing and Trail Making Test Part B. Changes in test performance from baseline will be summarized over the assessment period. |
| Other | Overall Survival | From Cycle 1 Day 1 (each cycle is 28 days) until death from any cause or the end of the study follow-up period for a maximum of 5 years. | Overall survival is defined as the time from Cycle 1 Day 1 (C1D1) to death from any cause. Overall survival will be summarized using the Kaplan-Meier method, with median overall survival and corresponding 95% confidence intervals reported, as applicable. |
| Other | BRAF V600E, Mismatch Repair Protein, and Pan-TRK Expression Status in Glioblastoma Tissue Samples | During prescreening or screening, before initiation of study treatment. | Glioblastoma tissue samples from patients undergoing prescreening or screening will be analyzed for BRAF V600E and mismatch repair (MMR) protein expression using immunohistochemistry (IHC). BRAF V600E testing will use the VE1 monoclonal antibody. MMR protein testing will assess MSH2, MSH6, PMS2, and MLH1. Pan-TRK IHC will be performed using the EPR17341 antibody, with staining intensity scored according to the specified scoring system. Samples with a Pan-TRK IHC score of 3+ will undergo confirmatory next-generation sequencing (NGS) to identify TRK gene fusions. Results will be reported according to the relevant test findings, including biomarker status and confirmatory molecular results where applicable. Samples may also be stored and used for future unspecified translational research as outlined within the informed consent form. |
| Other | Translational Biomarker Analyses of Whole Blood, Plasma, Serum, and Peripheral Blood Mononuclear Cells | From baseline (before initiation of study treatment) through the treatment period and disease progression, total of 12 months. | Translational blood samples, including whole blood (WB), plasma, serum, and peripheral blood mononuclear cells (PBMCs), will be collected for biomarker analyses related to treatment response and resistance in patients with newly diagnosed glioblastoma treated with plixorafenib, cadonilimab, or larotrectinib. Samples may also be stored and used for future unspecified translational research as outlined within the informed consent form. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07908147/registered