Trial · NCT04815720
Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT04815720, Phase 1, Phase 2, Completed, Vaccinex Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. Trials, record NCT04815720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04815720
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT04815720
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Vaccinex Inc.
- Conditions
- Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Interventions
- pepinemab + pembrolizumab
- First posted
- 2021-03-25
- Last updated
- 2025-01-08
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects with Treatment Emergent Adverse Events (TEAE's). | 2 Years | TEAE's are defined as Adverse Events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IMP but increased in severity or relationship after date-time of first dose of IMP. |
| Primary | Evaluation of RP2D | 2 Years | Review number of subjects with incidence of laboratory abnormalities based on hematology, clinical chemistry, and urinalysis test results with consideration to ECG, vital sign measurements and physical examinations. |
| Primary | Efficacy Endpoint | 2 Years | To be determined by the ORR of the combination pepinemab and pembrolizumab first-line treatment in patients with R/M HNSCC. This is defined as complete response (CR) or PR according to RECIST 1.1 from the first dose until documented confirmed disease progression. |
| Secondary | Duration of Response (DoR) | 2 Years | To be measured from the first date of response (CR or PR) until the development of progressive neoplastic disease or death from any cause. |
| Secondary | Overall Survival (OS) | 2 Years | To be measured from the date of the first dose (Day 1 of Cycle 1) until death from any cause. |
| Secondary | Progression Free Survival (PFS) | 2 Years | To will be measured based on the RECIST 1.1 criteria from the date of enrollment until the development of progressive neoplastic disease or death from any cause. |
| Secondary | Extent of Disease (EOD) | 2 Years | To based on radiographic findings on computed tomography (CT) or magnetic resonance imaging (MRI) scan. |
| Secondary | Pharmacokinetic (PK) Endpoints | 2 Years | Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-∞). |
| Secondary | Pharmacokinetic (PK) Endpoints | 2 Years | AUC from time zero to the time of the last quantifiable concentration (AUC0-tlast). |
| Secondary | Pharmacokinetic (PK) Endpoints | 2 Years | Maximum observed plasma concentration (Cmax). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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.
Papers37
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/NCT04815720
GET https://conductscience.org/api/trials/v1/NCT04815720/papers?page=2