eo-adjuvant Pembrolizumab in vulvar squamous cell carcinoma: a clinical proof-of-concept study.
- Conditions
- vulvar carcinoma1004090010029903
- Registration Number
- NL-OMON53949
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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.
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 <=Grade 1 or baseline. Participants with <=Grade 2 neuropathy may be eligible.
Note: If participant received major surgery, they must have recovered
adequately from the toxicity and/or complications from the intervention prior
to starting study treatment.
5. Prior radiotherapy within 2 weeks of start of study treatment. Participants
must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis.
6. Major surgery within 2 weeks of starting study treatment and patients must
have recovered from any effects of any major surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. To study the clinical efficacy of neoadjuvant PD-1 blockade in VSCC, as<br /><br>measured by an objective change in tumor size (according to RECIST 1.1) and<br /><br>documented by calipers using standardized digital photography with reference<br /><br>ruler) at the time of surgery (approximately 6 weeks after first administration<br /><br>Pembrolizumab).<br /><br>2. To study the activation, proliferation and migration of CD4+CD39+PD-1+<br /><br>effector T cell population upon PD-1 blockade.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To study pathological complete responses (pCR) at time of surgery<br /><br>2. To study feasibility(defined as delay in planned surgery and surgical<br /><br>outcome), safety according to NCI-CTC version 5.0<br /><br>3. To study the activation, proliferation and migration of the<br /><br>CD8+CD103+CD39+PD-1+ intratumoral T-cell population upon PD-1 blockade.</p><br>