MedTrace Logo

Neo-adjuvant Pembrolizumab in Vulvar Squamous Cell Carcinoma: a Clinical Proof-of-concept Study

NCT05761132 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-09

No results posted yet for this study

Summary

Rationale:

Vulvar squamous cell carcinoma (VSCC) is a rare cancer with a rising incidence. Standard treatment comprises wide local excision of the primary tumour and inguinal lymph nodes and sometimes (chemo) radiotherapy. Treatment is associated with impressive and long-lasting morbidity, sexual and psychological dysfunction and wound healing disorders. Recurrent disease develops in up to 40% of all treated patients. The unmet need, therefore, is a less radical and more effective treatment for VSCC.

Hypothesis:

Based on the local immune profile in a large fraction of patients with primary VSCC the investigators hypothesize that neoadjuvant PD-1 checkpoint inhibition may reinvigorate tumor-specific T cells resulting in a reduced tumor load, potentially leading to less radical surgery and reduces the recurrence rate.

The primary objectives of this trial are to study clinical efficacy and immune activation of neoadjuvant PD-1 blockade in VSCC.

Study design: This is a prospective, multicenter phase II non-controlled clinical trial in 40 VSCC patients.

Study population: Clinically diagnosed FIGO I-III primary VSCC patients to be treated with surgery with curative intent.

Intervention (if applicable):

Anti-PD1 antibody pembrolizumab, 200 mg IV Q3W for a total of 2 administrations per patient over a period of 6 weeks prior to surgery.

Main study parameters/endpoints:

The primary endpoints are:

* Clinical efficacy of neoadjuvant PD-1 blockade in VSCC, measured by objective change in tumour size (according to RECIST1.1)
* The activation, proliferation and migration of the CD4+CD39+PD-1+ intratumoral T-cell population.

Conditions

  • Vulva Cancer
  • Vulva Neoplasm
  • Squamous Cell Cancer

Interventions

DRUG

Pembrolizumab

neoadjuvant immunotherapy

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Drug
Yes

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761132 on ClinicalTrials.gov