Trial · NCT03268057
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 | Dose Escalation Phase: Number of subjects with dose-limiting toxicities (DLT)s at each dose level | 21 Days for Each Escalation Phase | DLTs will be described and graded according to the Common Terminology Criteria Adverse Events version 4.03 (CTCAE v4.03) and according to the specific MedRA terms from immune mediated AEs |
| Primary | Dose Expansion Phase: Frequency and type of adverse events (AE)s | 2 Years | Safety assessments will be performed on a regular basis using physical examination, spontaneous AE reporting, scheduled and unscheduled laboratory assessments, and other diagnostic evaluations as indicated. Adverse events will be reported using the Common Terminology Criteria Adverse Events version 4.03 (CTCAE v4.03). |
| Secondary | Dose Expansion Phase: Objective Response (OR) | 2 Years | This is defined as complete response (CR) or partial response (PR) according to RECIST 1.1 from first dose until documented confirmed disease progression. |
| Secondary | Dose Expansion Phase: Duration of Response (DoR) | 2 Years | This is defined, for subjects with an objective response, as the time from first confirmed documented objective response (CR or PR) to the date of first confirmed documented objective progression of disease (PD) or death. |
| Secondary | Dose Expansion Phase: Progression Free Survival (PFS) | 2 Years | This is defined as the time from first dose to the date of the first confirmed documented objective progression of disease (PD) or death |
| Secondary | Dose Expansion Phase: Peak serum concentration (Cmax) of VX15/2503 and avelumab | 2 Years | PK Parameter |
| Secondary | Dose Expansion Phase: Area under the serum concentration versus time curve (AUC) of VX15/2503 and avelumab | 2 Years | PK Parameter |
| Secondary | Dose Expansion Phase: Half-life of VX15/2503 and avelumab | 2 Years | PK Parameter |
| Secondary | Dose Expansion Phase: Immunogenicity of VX15/2503 and avelumab as measured by frequency and titer of human anti human antibodies | 2 Years | Anti Drug Antibodies (ADA) |
| Secondary | Dose Expansion Phase: Receptor occupancy of VX15/2503 and avelumab as measured by a flow cytometry based saturation assay | 2 Years | PD Parameter |
| Secondary | Dose Expansion Phase: Cellular SEMA4D levels as measured by flow cytometry | 2 Years | PD Parameter |
| Secondary | Dose Expansion Phase: Total soluble SEMA4D levels as measured by ELISA | 2 Years | PD Parameter |
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/NCT03268057/registered