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Trial · NCT03625323

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryEvaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
PrimaryEvaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
SecondaryDuration of (Serious) Adverse Eventsup to 27 months
SecondaryFrequency of (Serious) Adverse Eventsup to 27 months
SecondarySeverity of (Serious) Adverse Eventsup to 27 months
SecondaryTime to Responses According to iRECIST and RECIST 1.1up to 68 months
SecondaryDuration of Responses According to iRECIST and RECIST 1.1up to 68 months
SecondaryResponse Rate According to RECIST 1.1up to 68 months
SecondaryDisease Control Rate According to iRECIST and RECIST 1.1up to 68 months
SecondaryProgression Free Survival (PFS)up to 68 months
SecondaryOverall Survival (OS)up to 68 months
SecondaryOccurrence of Eftilagimod Alpha-specific Antibodies (ADA)up to 24 month
SecondaryPlasma Concentration Time Profile of Eftilagimod Alphaup to 24 month

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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