Table of Contents
- Trial overview
- Who was studied
- Treatment and study design
- What was measured
- What the trial aimed to show
- Key patient points
Trial overview
The provided trial data describe one interventional study, which means researchers gave treatment and then measured the results.[1] This study was a Phase 2 trial and it was completed.[1] The trial enrolled 112 people.[1]
The study tested Vorinostat together with pembrolizumab in patients with advanced mucosal squamous cell cancers.[1] The brief summary says the trial looked at the antitumor activity of this combination in recurrent and/or metastatic disease.[1]
Who was studied
The trial included patients with squamous cell carcinoma of the head and neck, cervix, anus, vulva/vagina, and penis.[1] The conditions listed in the source also include squamous cell carcinoma of the lung, but the lung cohort was closed to recruitment.[1]
These cancers are described in the study as advanced, recurrent, and/or metastatic.[1] In simple words, this means the cancer had come back, spread, or was already far along when patients entered the study.[1]
Treatment and study design
Vorinostat was given with pembrolizumab in this trial.[1] The intervention list shows Vorinostat as an oral drug and pembrolizumab as an intravenous treatment.[1]
The study title and summary both point to the same main idea: the researchers wanted to see whether this combination could help patients with difficult-to-treat mucosal cancers.[1] Because this was a Phase 2 study, the main purpose was to look for signs that the treatment might work in this patient group.[1]
What was measured
The main endpoint was overall response rate (ORR).[1] ORR is the percentage of patients whose best tumor response was either a complete response or a partial response.[1]
A complete response means no visible signs of cancer remain, while a partial response means the cancer got smaller but did not disappear completely.[1] The trial measured response using RECIST v1.1, which is a standard method for checking changes in tumor size during a study.[1]
What the trial aimed to show
The main goal was to evaluate the antitumor activity of pembrolizumab combined with Vorinostat in patients with recurrent and/or metastatic squamous cell carcinoma.[1] Antitumor activity means whether the treatment can help stop the cancer from growing or make it shrink.[1]
The trial focused on several body sites, not just one cancer type, which shows it was designed for a group of related mucosal cancers.[1] The source data do not provide other endpoint details beyond ORR, so the main measured outcome in this article is the tumor response rate.[1]
Key patient points
Vorinostat was studied in a combination treatment with pembrolizumab, not by itself.[1]
The trial was for people with advanced squamous cell cancers of the head and neck, cervix, anus, vulva/vagina, penis, and lung.[1]
The study was completed and included 112 participants.[1]
The main result was ORR, a simple way to measure how many patients had their tumors shrink.[1]
The lung cohort was closed to recruitment, so that group was no longer enrolling new patients.[1]
