Trial · NCT06791460
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 | Objective response rate (ORR) | Month 6 | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). ORR was defined as the percentage of participants who had a Complete Response (Disappearance of all target lesions) or a Partial Response (≥30% decrease in the sum of the longest diameter of target lesions) using RECIST 1.1 based on BICR. |
| Secondary | Progression Free Survival (PFS) at 6 Months | Month 6 | PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS at 6 months is defined as the percentage of patient who was progression free at 6 months from the randomization. |
| Secondary | Overall Survival (OS) at 6 Months | Month 6 | OS at 6 months is defined as the percentage of patients who are alive at 6 months from the randomization. |
| Secondary | Progression Free Survival (PFS) at 12 Months | Month 12 | PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1 PD was defined as ≥20% increase in SOD of target lesions and an absolute SOD increase of ≥5 mm. The appearance of ≥1 new lesion is also PD. PFS at 12 months is defined as the percentage of patient who was progression free at 12 months from the randomization. |
| Secondary | Overall Survival (OS) at 12 Months | Month 12 | OS at 12 months is defined as the percentage of patients who are alive at 12 months from the randomization. |
| Secondary | Incidence of grade 3-4 Adverse Events (AEs) | up to 1 month after the end of treatment | Incidence of grade 3-4 AEs, according to CTCAE, version 5.0 |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for PD-L1 expression in exploratory analysis. |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for BMI (weight and height will be combined to report BMI in kg/m\^2) in exploratory analysis. |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for tumor microenvironment (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis. |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for circulating anti-tumor immunity (including density and state of CD8+ T cells density and other immune cells) in exploratory analysis. |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for transcriptome in exploratory analysis. |
| Other | Exploratory outcome: biomarkers testing and efficacy of anti-tumor immunity | Baseline and 6 months from the randomization | Biomarker testing for genome in exploratory analysis. |
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/NCT06791460/registered