Trial · NCT03277924
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1 - PHASE 1 | 6 months | The recommended dose of the sunitinib and nivolumab combination for phase II part will be determined by assessing adverse events according to CTCAE 4.0 and they will be used as a rule for escalating or diminishing dose levels according to the dose-limiting toxicities detailed in the protocol |
| Primary | Stage 1 - PHASE 2 | 6 months | Progression-free survival rate (PFSR): Efficacy measured by the PFSR at 6 months according to RECIST 1.1. PFSR at 6 months is defined as the percentage of patients who did not experience progression or death due to any cause since enrollment until month 6 after enrollment. |
| Primary | Stage 2 - Cohort 1-6: Progression-free survival rate (PFSR) | 6 months for CS/DDCS, EMC, VS, SFT, and CCS and 12 months for ASPS | CS/DDCS, EMC, VS, SFT, and CCS cohorts: 6-month progression-free survival rate (PFSR): Efficacy measured by the PFSR at 6 months according to RECIST 1.1. PFSR at 6 months is defined as the percentage of patients who did not experience progression or death due to any cause since enrollmentuntil month 6 after enrollment. ASPS cohort: 12-month progression-free survival rate (PFSR): Efficacy measured by the PFSR at 12 months according to RECIST 1.1. PFSR at 12 months is defined as the percentage of patients who did not experience progression or death due to any cause since the date of enrollment until month 12 after enrollment. |
| Primary | Stage 2 - Cohort 7: Maximum tolerated dose (MTD) | 1 year | The maximum tolerated dose (MTD) of the epirubicin + ifosfamide + nivolumab combination will be determined by assessing adverse events according to CTCAE 5.0 and they will be used for adjusting dose levels according to the dose-limiting toxicities detailed in the protocol. |
| Primary | Stage 2 - Cohort 8: Maximum tolerated dose (MTD) | 1 year | The maximum tolerated dose (MTD) of the MAP + nivolumab combination will be determined by assessing adverse events according to CTCAE 5.0 and they will be used for adjusting dose levels according to the dose-limiting toxicities detailed in the protocol. |
| Secondary | Stage 1 and Stage 2 - Overall survival (OS) | 2 years | OS is defined as the time between the date of enrollment and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. |
| Secondary | Stage 1 and Stage 2 - Objective response rate (ORR) | 2 months | ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects (according to RECIST 1.1 criteria). |
| Secondary | Stage 2 - Cohort 1-6 Correlation between efficacy and potential predictive biomarkers | 2 years | Assessed by finding relationships between clinical efficacy results and translational data. |
| Secondary | Stage 1 and Stage 2 - Safety profile: Adverse events | 3 years | Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests. Toxicity will be graded and tabulated by using CTCAE 5.0. |
| Secondary | Stage 1 (PHASE 2) and Stage 2 - Cohort 1-6 Clinical outcome | At 36 months | Clinical outcomes of post protocol treatments assessed by observation of such treatments in follow-up stage. |
| Secondary | Stage 2 - Cohort 1-6 Prognostic and response correlation | 1 month | Prognostic and response correlation with neutrophils/platelets; lymphocytes/platelets; andred blood cell distribution width (RDW), by assessing hematology tests at baseline, after 2 weeks (before nivolumab), after 1 month, at progression, and at response. |
| Secondary | Stage 1 (PHASE 1) and Stage 2 - Cohort 1-6 6-month progression-free survival rate (PFSR) | 6 months | Efficacy measured by the PFSR at 6 months according to RECIST 1.1. PFSR at 6 months is defined as the percentage of patients who did not experience progression or death due to any cause since the date of enrollment until month 6 after enrollment. |
| Secondary | Stage 2 - Cohort 7 Median progression-free survival (mPFS) | 6 months | PFS is defined as the time between the date of enrollment and the date of progression or death due to any cause. |
| Secondary | Stage 2 - Cohort 7 Median overall survival (mOS) | 2 years | OS is defined as the time between the date of enrollment and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. |
| Secondary | Stage 2 - Cohort 8 Pathological response | At month 3 | Measured by percentage of necrosis in surgical specimen. |
| Secondary | Stage 1 (PHASE 2) | 3 years | Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow up until tumor progression |
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/NCT03277924/registered