Trial · NCT04256421
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months) | PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). |
| Primary | Overall Survival (OS) in the PAS | From randomization to death from any cause (up to approximately 24 months) | OS was defined as the time from randomization to death from any cause. |
| Secondary | PFS in the FAS | From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 24 months) | PFS was defined as the time from randomization to the first documented PD as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | OS in the FAS | From randomization to death from any cause (up to approximately 24 months) | OS was defined as the time from randomization to death from any cause. |
| Secondary | Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS | From randomization up to approximately 24 months | ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. |
| Secondary | Investigator-assessed Confirmed ORR in the FAS | From randomization up to approximately 24 months | ORR was defined as the percentage of participants with CR or PR as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. |
| Secondary | Investigator-assessed Duration of Response (DOR) in the PAS | From the first occurrence of a documented confirmed objective response (OR) to PD or death from any cause, whichever occurred first (up to approximately 24 months) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | Investigator-assessed DOR in the FAS | From the first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 24 months) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. |
| Secondary | Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS | Month 6, Month 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the Kaplan-Meier (K-M) method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
| Secondary | Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS | Month 6, Month 12 | PFS rate at 6 months and 12 months was defined as the percentage of participants who were event-free at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
| Secondary | OS Rates at 12 Months and 24 Months in the PAS | Month 12, Month 24 | OS rate at 12 months and 24 months was defined as the percentage of participants who were alive at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
| Secondary | OS Rates at 12 Months and 24 Months in the FAS | Month 12, Month 24 | OS rate at 12 months and 24 months was defined as the percentage of participants who were alive at these specific time points. Percentages have been rounded off to the nearest decimal point. A point estimate of the event-free rate was a single, numerical value used to approximate the true event-free rate of the entire population at a specific point in time. This value was calculated from ordered data (Event, Censoring) of each participant, using the K-M method, accounting for censored observations (so event-free rates may not directly be calculated based only on participants remaining at risk). |
| Secondary | Time to Confirmed Deterioration (TTCD) of European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (PF) in the PAS | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months) | TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in PF. TTCD was determined based on patient-reported PF (Items 1-5) as collected and measured by the EORTC QLQ-C30. The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). A high score for the PF subscale represented a high/healthy level of functioning. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in PF subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. |
| Secondary | TTCD of EORTC QLQ-C30 Physical Functioning in the FAS | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months) | TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in PF. TTCD was determined based on patient-reported PF (Items 1-5) as collected and measured by the EORTC QLQ-C30. The PF was measured on 4-point scale (1='Not at all' to 4='Very much'). A high score for the PF subscale represented a high/healthy level of functioning. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in PF subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. |
| Secondary | TTCD of EORTC QLQ-C30 Global Health Status (GHS)/Quality-of-life (QoL) in the PAS | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months) | TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in patient-reported GHS/QoL. TTCD was determined based on patient-reported GHS/QoL (Items 29-30) as collected and measured by the EORTC QLQ-C30. GHS/QoL items were scored on a 7-point scale, ranging from "very poor" to "excellent". A high score for the GHS/QoL subscale represented a high health-related QoL. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in GHS/QoL subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. |
| Secondary | TTCD of EORTC QLQ-C30 GHS/QoL in the FAS | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 24 months) | TTCD was the time from randomization until the first confirmed clinically meaningful deterioration in patient-reported GHS/QoL. TTCD was determined based on patient-reported GHS/QoL (Items 29-30) as collected and measured by the EORTC QLQ-C30. GHS/QoL items were scored on a 7-point scale, ranging from "very poor" to "excellent". A high score for the GHS/QoL subscale represented a high health-related QoL. The scale was linearly transformed so that each score ranged from 0 to 100. A score change of at least 10-point in GHS/QoL subscale score was perceived by participants as clinically meaningful. Confirmed clinically meaningful deterioration was defined as a clinically meaningful decrease from baseline that was held for at least two consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to 58 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study were also considered as AEs. |
| Secondary | Number of Participants With Severity of Cytokine-release Syndrome (CRS), as Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale | Up to 58 months | CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension \& hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS. Only non zero values have been reported. |
| Secondary | Minimum Serum Concentration (Cmin) of Tiragolumab | At the end of Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) (1 Cycle=21 days) | |
| Secondary | Cmin of Atezolizumab | At the end of each Cycles 1, 2, 3, 7, 11 and 15 (approximately 11 months) (1 Cycle=21 days) |
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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