Pembrolizumab Trial in Head and Neck Cancer Posts Results

ClinicalTrials.gov posted results on 2026-08-17 for NCT03650764, a completed phase 1/phase 2 trial of ramucirumab plus pembrolizumab in recurrent or metastatic head and neck squamous cell carcinoma. The study enrolled 43 participants and evaluated the combination’s recommended phase 2 dose, objective response outcome, and adverse-event profile.

Background

The trial evaluated pembrolizumab with ramucirumab in participants with head and neck squamous cell carcinoma. The investigators hypothesized that combining inhibition of angiogenesis with PD-1 inhibition could be more effective than PD-1 inhibition alone. The initial part of the protocol focused on establishing the safety and feasibility of the combination through a phase 1 de-escalation design. Pembrolizumab is also known as Keytruda.

Trial design

This was a phase 1/phase 2 study listed as completed, with 43 participants. The phase 1 portion used dose de-escalation, treating three participants at each dose level and moving to the next dose level if two or more participants experienced ramucirumab-attributable dose-limiting toxicities. The posted intervention was ramucirumab plus pembrolizumab in participants with head and neck squamous cell carcinoma.

Key results

The posted phase 1 measurement identified a recommended phase 2 dose of ramucirumab combined with fixed-dose pembrolizumab at 10 mg/kg for the phase 1 dose-level group. For the phase 2 objective response rate outcome, the record lists 18 participants in the ramucirumab 10 mg/kg plus pembrolizumab group. The posted measurement does not provide a percentage response rate, dispersion value, p-value, or confidence interval.

The adverse-event measurements were reported separately for the phase 1 dose-level group and the phase 2 group. Recorded participant counts were 1 and 33 for one listed adverse-event measure; 1 and 3 for another; 1 and 0 for another; and 0 and 1 for each of three additional listed measures. The record excerpt does not identify the event categories corresponding to these counts.

What this means

The posted record establishes a 10 mg/kg ramucirumab dose for the phase 2 combination group and reports participant counts for the objective-response and adverse-event outcomes. Because the available measurements do not include response percentages, event definitions, statistical analyses, or a pembrolizumab-alone comparator result, they do not establish comparative efficacy from this record alone.

Source

This article is based on results posted by ClinicalTrials.gov on 2026-08-17 for NCT03650764. The source document is the ClinicalTrials.gov study record, available at clinicaltrials.gov.