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Trial · NCT07218380

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of participants with treatment-related adverse events related to vepugratinib in combination with EV and pembrolizumabFrom baseline up to 90 months
PrimarySafety Lead-in: Overall Response Rate (ORR)From baseline up to 90 monthsORR by Investigator Assessment.
PrimaryProgression-free Survival (PFS)Baseline to Study Completion (estimated as 6 years)PFS by blinded independent committee review (BICR).
SecondarySafety Lead-in: Disease Control Rate (DCR)From baseline up to the end of Cycle 2 (each Cycle is 21 days)DCR by investigator assessment.
SecondarySafety Lead-in: Time to Response (TTR)From baseline up to 90 monthsTTR by investigator assessment.
SecondaryOverall Survival (OS)Baseline to Study Completion (estimated as 6 years)
SecondaryObjective Response Rate (ORR) by BICRBaseline to Study Completion (estimated as 6 years)
SecondaryDuration of Response (DoR)Baseline to Study Completion (estimated as 6 years)DOR by BICR.
SecondaryProgression-free Survival (PFS)Baseline to Study Completion (estimated as 6 years)PFS by investigator assessment.
SecondaryObjective Response Rate (ORR)Baseline to Study Completion (estimated as 6 years)Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)ORR by investigator assessment
SecondaryDuration of Response (DOR)Baseline to Study Completion (estimated as 6 years)DOR by investigator assessment.
SecondaryProgression-free Survival 2 (PFS2)Baseline to Study Completion (estimated as 6 years)PFS2 by investigator assessment.
SecondaryPlasma Concentrations of VepugratinibCycle 1 Day 1 to Study completion (estimated as 90 months)PK samples are to be drawn every odd cycle while participant on study.
Secondary
Change from Baseline in Global Health Status/Quality of Life (QOL) and Physical Function Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Baseline to Study Completion (estimated as 6 years)
The EORTC QLQ-C30 is a validated self-reported general cancer questionnaire consisting of 30 items with a recall of the past 7 days. Response options range from 1) "very poor" to 7) "excellent." Higher scores represent better overall HRQoL.

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.

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