Trial · NCT03268057
VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer
NCT03268057, Phase 1, Phase 2, Completed, Vaccinex Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer. Trials, record NCT03268057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03268057
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer
- NCT number
- NCT03268057
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Vaccinex Inc.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- VX15/2503 + avelumab
- First posted
- 2017-08-31
- Last updated
- 2022-05-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03268057
GET https://conductscience.org/api/trials/v1/NCT03268057/registered