Trial · NCT02960906
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment | 54 months | ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (nivolumab monotherapy, nivolumab combined with ipilimumab, or TKI: sunitinib or pazopanib), based on Investigator assessments. |
| Secondary | Progression-free survival (PFS) | 54 months | progression-free survival (PFS) in subjects with previously untreated mRCC according to molecular groups and assigned treatment, based on Investigator radiological assessments. |
| Secondary | Overall Survival | 54 months | To evaluate OS in subjects with previously untreated mRCC according to molecular groups and assigned treatment. |
| Secondary | Objective response rate at 22 weeks | at 22 weeks | To evaluate objective response rate at 22 weeks as a surrogate of other endpoints according to molecular groups and assigned treatment. |
| Secondary | Duration of treatment (DOT) | 54 months | To evaluate the duration of treatment (DOT) of nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in subjects with previously untreated mRCC according to their molecular subgroup (1\&4 vs 2\&3). |
| Secondary | Duration of response (DOR) | 54 months | To evaluate the duration of response (DOR) of nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in subjects with previously untreated mRCC according to their molecular subgroup (1\&4 vs 2\&3). |
| Secondary | Number of Participants With Treatment-Related Adverse Events | 54 months | To estimate the incidence of AEs associated with nivolumab combined with ipilimumab or nivolumab alone or cabozantinib in all treated subjects with previously untreated mRCC. |
| Secondary | Gene expression of immune population markers | at baseline at progression (36 months maximum) | To assess gene expression of immune population markers in the primary tumor as well as in the metastases before beginning treatment, and at progression if safely achievable.populations (CD3, CD8...) and regulatory markers (PD-1, LAG-3…) within the primary tumor, and metastases whenever possible, using frozen and FFPE tumor tissue. |
| Secondary | Gene expression levels obtained from FFPE | at the end of the study (36 months) | Gene expression levels obtained from FFPE tumor tissue (exploratory method) will be compared to those obtained with frozen tumor tissue (standard method). |
| Secondary | Functional status of peripheral blood lymphocytes (PBL) | at baseline, at cycle 2 and at progression (36 months maximum) | To assess the functional status of peripheral blood lymphocytes (PBL) by flow cytometry, before treatment initiation, during treatment, and at progression. |
| Secondary | Association between non-immune tissue and circulating biomarkers and outcomes | 36 months maximum | To explore the association between non-immune tissue and circulating biomarkers and outcomes (ORR, ORR at 22 weeks, OS and PFS). |
| Secondary | Mutation and methylation analysis of circulating tumor DNA | 36 months maximum | The initial rate of ctDNA and its evolution will be correlated to the clinical evolution of patients and progression-free survival. |
| Secondary | Genetic and epigenetic alterations | 36 months maximum | To identify genetic and epigenetic alterations associated with either response or resistance to immune checkpoint inhibitors and tyrosine kinase inhibitors. |
| Secondary | association between immune cells composing tumor microenvironment and response and/or resistance | 36 months maximum | To evaluate the association between immune cells composing tumor microenvironment and response and/or resistance to immune checkpoint inhibitors or tyrosine kinase inhibitors. |
| Secondary | additional genetic and epigenetic tumor alterations | 36 months maximum | To evaluate additional genetic and epigenetic tumor alterations at resistance/progression or after resection of residual mass. |
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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