Trial · NCT05903833
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR within 24 weeks | 24 weeks | ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall ORR | From date of starting study treatment until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months | Overall ORR |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of disease control rate (DCR) | For 8 weeks | DCR will be defined as the proportion of patients with PR, CR or stable disease (SD) |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of duration of response (DOR) | Time from response until first progression or death, whichever occurs first, assessed up to 40 months | DOR will be defined as time from response until first progression or death, whichever occurs first |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall survival (OS) | Time from date of starting study treatment to death, assessed up to 40 months | OS will be defined as the time from date of starting study treatment to death. |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of progression free survival (PFS) | Time from starting study treatment to progressive disease or death, whichever occurs first, assessed up to 40 months | PFS will be defined as the time from starting study treatment to progressive disease (PD) or death, whichever occurs first |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of time to first subsequent therapy (TFST) | The time from date of starting study treatment until the start of the first subsequent therapy or death whichever occurs first, assessed up to 40 months | • TFST will be defined as the time from date of starting study treatment until the start of the first subsequent therapy or death whichever occurs first. |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of time to second subsequent therapy (TSST) | Time from date of starting study treatment until the start of second subsequent treatment or death whichever occurs first, assessed up to 40 motnhs | • TSST will be defined as the time from date of starting study treatment until the start of second subsequent treatment or death whichever occurs first. |
| Secondary | Patient reported outcomes (QLQ) | Assessed frequently during the trial up to 40 months | Quality of life is measured by patient reported outcome instruments EORTC QLQ C-30 to evaluate the efficacy of combination of lenvatinib and pembrolizumab |
| Secondary | Patient reported outcomes (QLQ) | Assessed frequently during the trial up to 40 months | Quality of life is measured by patient reported outcome instruments EORTC QLQ VU34 to evaluate the efficacy of combination of lenvatinib and pembrolizumab |
| Secondary | Number of participants with treatment-related adverse events (AE) and/or serious adverse events (SAEs) and/or AEs that led to premature withdrawal of trial treatment and/or interruptions/dose modifications | At every visit during the trial up to safety follow, thereafter up to 120 days after administration of last dose of study medication | Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, to evaluate the safety and tolerability of the combination of lenvatinib and pembrolizumab |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05903833/registered