Trial · NCT03753919
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 | Progression-free Survival Rate at 6 Months | Throughout the study period, up to 6 months from start of treatment | 6-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 24 weeks after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s). |
| Primary | Overall Survival Rate at 6 Months | Throughout the trial period, up to 6 months from first dose of treatment. | Defined as percentage of patients alive at month 6 from first dose of treatment. |
| Secondary | Overall Survival, Median | Throughout the trial period, with a following up to 4 years from the start of treatment | Median OS, defined as the time from the start of treatment until death (patients without events were censored at the last follow-up). Estimated by Kaplan-Meier |
| Secondary | Overall Survival Rate at 18 Months | Throughout the trial period, up to 18 months from first dose of treatment. | Percentage of patients alive at month 18 from first dose of treatment. |
| Secondary | Progression-free Survival (PFS), Median | Throughout the trial period, a median follow-up period 14 months from the start of treatment | median PFS, defined as the time from the start of treatment until disease progression (PD) according to RECIST v1.1 or death (patients without events were censored at the last tumor assessment). Estimated by Kaplan-Meier. Per RECIST v1.1, PD: for target lesions, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. For non-target lesions: unequivocal progression of existing non-target lesions or appearance of new lesions. |
| Secondary | Progression-free Survival Rate at 18 Months | Throughout the study period, up to 18 months from start of treatment | 18-months progression-free survival by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at 18 months after durvalumab plus tremelimumab was started without observing disease progression or death at this time point. Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression disease. For non-target lesions, CR: Disappearance of all non-target lesions; Non-CR/Non-PD: Persistence of one or more non-target lesion(s). |
| Secondary | Overall Response Rate (ORR) | Through study completion, average 1 year | Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria or iRECIST 1.1 criteria |
| Secondary | Overall Response (OR) Best Response According to RECIST 1.1 | Throughout the trial period, with a following up to 4 years from the start of treatment | Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions. |
| Secondary | Overall Response (OR) Best Response According irRecist Criteria | Throughout the trial period, with a following up to 4 years from the start of treatment | Defined as patients who achieved partial response (PR) or complete response (CR) as best response according to irRecist criteria. |
| Secondary | Duration of Response (DoR) Median RECIST 1.1 Criteria | Through study period, assessed up to 4 years | Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment RECIST 1.1 criteria Per RECIST for target lesions, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: Disappearance of all non-target lesions. |
| Secondary | Duration of Response (DoR) Median irRECIST Criteria | Through study period, assessed up to 4 years | Defined as the time from the first PR/CR to disease progression or the last tumor assessment. DoR will be determined based on tumour assessment according to irRECIST criteria |
| Secondary | Percentage of Participants With Treatment-Related Adverse Events (TRAEs) | Throughout the study period, from start treatment up 90 days after the last dose, up to 5 years. | Percentage of patients who presented adverse events related with study treatment throughout the study period, Toxicity will be evaluated according NCI CTCAE v 5.0 criteria. AEs and SAEs will be collected from the time of the patient signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab ± tremelimumab). |
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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GET https://conductscience.org/api/trials/v1/NCT03753919/registered