Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 17 of 17

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg	From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).	The FAS included all participants who were randomized. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg	From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).	The FAS included all participants who were randomized. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Overall Survival (OS) at 18, 24, and 36 Months After Randomization	At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).	The FAS included all participants who were randomized. T75+D arm was closed during study.	percentage of survival	NUMBER
SECONDARY	Progression Free Survival (PFS)	Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)	The FAS included all participants who were randomized. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Time To Progression (TTP)	From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	The FAS included all participants who were randomized. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Objective Response Rate (ORR)	From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	The FAS included all participants who were randomized. T75+D arm was closed during study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Control Rate (DCR)	From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	The FAS included all participants who were randomized. T75+D arm was closed during study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Objective Response (DoR)	From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Overall Survival (OS) by PD-L1	From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	A subset of FAS who had non-missing baseline PD-L1 status. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration	At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.	A subset of the FAS who had baseline scores of \>=10. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration	At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.	A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration	At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.	A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration	At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.	A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.	months	MEDIAN
SECONDARY	Presence of ADA for Durvalumab	Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).	The Durvalumab ADA evaluable set includes all participants who received at least 1 dose of Durvalumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Durvalumab. T75+D arm was closed during study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Presence of ADA for Tremelimumab	Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.	The Tremelimumab ADA evaluable set includes all participants who received at least 1 dose of Tremelimumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Tremelimumab. T75+D arm was closed during study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Summary of Durvalumab Concentration Over Time	To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).	PK analysis set includes all participants who received at least 1 dose Durvalumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.	ug/mL	GEOMETRIC_MEAN
SECONDARY	Summary of Tremelimumab Concentration Over Time	To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).	PK analysis set includes all participants who received at least 1 dose of Tremelimumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.	ug/mL	GEOMETRIC_MEAN

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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