vulvar carcinoma
Conditions
Interventions
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.
Extension phase: Responders have the option to participate in
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to performance of study- specific procedures or assessments, and must be willing to comply with treatment and follow- up assessments. 2. Age >= 18 years old at the day of signing informed consent 3. Histologically confirmed primary vulvar squamous cell carcinoma, with all of the following characteristics: - At least 1 lesion that can be measured in at least 1 dimension with >= 10 mm in largest diameter. - Clinically stage FIGO I-III. - Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice. Routine exams to discard metastases will be performed according to Investigator judgement but are mandatory in case of suspicion of metastatic disease. - Vulvar cancer eligible for primary surgery - In the case of a multifocal tumor (defined as the presence of two or more foci of cancer on the vulva), the largest lesion must be >= 10 mm and all lesions >= 10 mm are designated as "target" lesion(s) for all subsequent tumor evaluations and biopsies.
Exclusion criteria
Exclusion criteria: 1. Locally advanced tumor not amenable to surgical therapy. 2. A woman of child bearing potential who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 3. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD37) 4. Prior systemic anti-cancer therapy including investigational agents within 4 weeks [prior to allocation. Note: Participants must have recovered from all AEs due to previous therapies to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study the clinical efficacy of neoadjuvant PD-1 blockade in VSCC, as measured by an objective change in tumor size (according to RECIST 1.1) and documented by calipers using standardized digital photography with reference ruler) at the time of surgery (approximately 6 weeks after first administration Pembrolizumab). 2. To study the activation, proliferation and migration of CD4+CD39+PD-1+ effector T cell population upon PD-1 blockade. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study pathological complete responses (pCR) at time of surgery 2. To study feasibility(defined as delay in planned surgery and surgical outcome), safety according to NCI-CTC version 5.0 3. To study 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