Trial · NCT03070392
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. | Overall survival is defined as the time from randomization to date of death due to any cause. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months. | Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings. |
| Secondary | Progression Free Survival (PFS) | PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months. | Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause. |
| Secondary | Change From Baseline in EQ-5D,5L Domain Scores | EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement. |
| Secondary | Change From Baseline in EQ-5D Visual Analogue Score (VAS) | EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Global Health Status | EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement. |
| Secondary | Tebentafusp Concentration | PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15. | Serum pharmacokinetics (PK) concentrations of tebentafusp were collected over time. |
| Secondary | Objective Response Rate (ORR) | DOR was assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | Objective response rate (ORR) is defined as the percentage of patients achieving an objective response (RECIST v1.1). |
| Secondary | Duration of Response (DOR) | DOR was assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression. The Kaplan-Meier estimates for the percentage of participants' DOR over time is presented. |
| Secondary | Disease Control Rate (DCR) | DCR was assessed every 3 months from randomization until disease progression, up to 5.5 years. | Disease control rate (DCR) is defined as the percentage of participants with either an objective response or stable disease (RECIST v1.1) |
| Secondary | Prevalence of IMCgp100 Anti-Drug Antibody (ADA) Formation at Week 9 | Week 9 | The numberof participants with ADA is reported. Treatment-induced and treatment-boosted prevalence is reported separately. ADA formation was assessed only in tebentafusp-treated participants. |
| Secondary | Best Overall Response (BOR) | BOR was assessed every 3 months from randomization until disease progression, up to 5.5 years. | The BOR of participants is presented. |
| Secondary | Time to Response (TTR) | TTR was assessed every 3 months from randomization until disease progression, up to 5.5 years. | TTR of participants is reported for participants achieving a complete response (CR) or partial response (PR). |
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.
For software
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