Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 19 of 19

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).
Secondary	Pharmacokinetic (PK) Endpoints	2 Years	Time of the maximum observed plasma concentration (tmax).
Secondary	Pharmacokinetic (PK) Endpoints	2 Years	Apparent plasma terminal elimination half-life (t1/2).
Secondary	Pharmacokinetic (PK) Endpoints	2 Years	Apparent total plasma clearance (CL/F).
Secondary	Pharmacokinetic (PK) Endpoints	2 Years	Apparent volume of distribution (Vz/F).
Secondary	Immunogenicity Endpoint	2 Years	The incidence and severity of specific antidrug antibodies (ADA) to pepinemab.
Secondary	Pharmacodynamic (PD) Endpoint	2 Years	Include receptor occupancy, cellular SEMA4D levels, and total soluble SEMA4D levels.
Other	On-Treatment Tumor Biopsies	2 Years	To be collected from the subjects who have readily accessible tumor tissue for determinations of T cell subpopulations and presence of MDSC and other myeloid suppressors (eg, M2 macrophage). These will be compared to pre-baseline tumor samples.
Other	Serum and CSF Levels of Neuroinflammatory Cytokines	2 Years	IL-1, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL13,IFNγ, TNF-α, TGFβ
Other	T- and B-Cell Quantitation by Flow Cytometry (TBNK)	2 Years	B cells, total count; Natural killer (NK) cells, total count; T cells, total count; Absolute CD4/CD8 count with ratio.

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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