eo-adjuvant Pembrolizumab in vulvar squamous cell carcinoma: a clinical proof-of-concept study. - APOLLO study

eids Universitair Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•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.

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