(APOLLO)Neo-adjuvant Pembrolizumab in vulvar squamous cell carcinoma: a clinical proof-of-concept study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512862-32-00

Acronym

NL82378.058.22

Enrollment

Registered

2024-09-10

Start date

2023-05-11

Completion date

Unknown

Last updated

2024-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar squamous cell carcinoma

Brief summary

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 Tcell population.

Detailed description

Pathological complete responses (pCR) at time of surgery, Feasibility (defined as delay in planned surgery and surgical outcomes), safety according to NCI-CTC version 5.0, The activation, proliferation and migration of the CD8+CD103+CD39+PD-1+ intratumoral T-cell population upon PD-1 blockade

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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 Tcell population.	—

Secondary

Measure	Time frame
Pathological complete responses (pCR) at time of surgery, Feasibility (defined as delay in planned surgery and surgical outcomes), safety according to NCI-CTC version 5.0, The activation, proliferation and migration of the CD8+CD103+CD39+PD-1+ intratumoral T-cell population upon PD-1 blockade	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026