Trial · NCT04091867
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is whether a dose-limiting toxicity (DLT) occurs | 13 weeks | Severe cetuximab-associated rash is defined as per Lacouture 2010 criteria69, namely \> 20 papules or pustules OR \> 5 areas of erythema or edema \< 1 cm (this is grade 3A) or \> 20 papules/pustules OR \> 5 areas of erythema or edema \< 1 cm AND pain, pruritus, or effect on emotions or functioning (this is a commonly used criteria for grading of rash specifically related to EGFR inhibitors, such as cetuximab). |
| Secondary | To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Locoregional disease | 13 weeks | Tumor response will be assessed in participants with measurable disease at start of therapy by measuring change in size (and/or FDG avidity) on CT (and/or PET/CT). LRC will be calculated as the time from completion of locoregional therapy until disease recurrence at the primary site or in the neck. |
| Secondary | To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Distant Control | 13 weeks | DC will be calculated as the time from completion of locoregional therapy until disease recurrence at a site other than the primary site or neck. |
| Secondary | To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Disease Free Survival | 13 weeks | DFS will be calculated as the time from completion of locoregional therapy until either disease recurrence at any site or until death. |
| Secondary | Overall Survival | 13 weeks | OS will be calculated as the time from diagnosis of LAHNSCC to death |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | To establish a gene signature panel on biopsy samples that can assess the response to sEphB4HSA |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | Evaluate immune infiltration by multiplex immunofluorescence |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | Blood samples to evaluate biomarkers of immune response including mass cytometry on circulating peripheral blood, and analysis of plasma cytokine, cleaved soluble ephrin-B2 as well as for evaluation of circulating auto-antibodies. Blood will be collected at baseline (before the administration of sEphB4) and after administration of sEphB4, as well as on day 22 of treatment and at the end of treatment at the follow-up visit. Cytokine mesoscale assays as well as Elisas will be used |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | Tumor or nodal tissue taken at the time of initial biopsy and after sEphB4 HSA and will be profiled for whole gene and transcriptome sequencing of FFPE tissue, tumor infiltrating lymphocytes; activation markers and antigen specific TCR utilization/diversity. |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | On long-term follow-up (6 months), tumor antigen specific T lymphocyte memory populations will be monitored for representation and robustness in in-vitro stimulation assays as potential biomarker of continued anti-tumor activity. PBMCs will be separately collected for this purpose. |
| Other | To assess target expression analysis, genomic, and immune analysis in tumor and blood samples obtained at baseline, after loading dose of s-EphB4-HSA, during CRT and at follow-up | 13 weeks | Circulating tumor DNA (ctDNA) will also be collected. |
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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