NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer (NCT03734809) | Clinical Trial Compass
Active — Not RecruitingPhase 2
NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer
Hong Kong, Singapore43 participantsStarted 2019-05-03
Plain-language summary
This is an open label, single arm, non-randomized, multi-site, phase 2 clinical trial of neoadjuvant pembrolizumab in combination with gemcitabine-cisplatin for 2 cycles,followed by concurrent pembrolizumab-cisplain-radiation, and then maintainence pembrolizumab monotherpy given every 3 weeks for a total treatment duration of 12 months, in previously untreated stage IVA ( UICC 8 th Edition ) nasopharyngeal cancer(NPC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of nasopharyngeal carcinoma (from primary lesion and/or lymph nodes) of WHO type II-III histology type will be enrolled in this study.
✓. Tumor confirmed EBV positive by EBER ISH assay
✓. AJCC 8th edition Stage IVA (i.e any T4 or any N3) based on the following diagnostic workup:
✓. Evaluation of tumor extent with MRI of the nasopharynx and neck. If MRI is medically contraindicated, CT scan with
✓. Distant metastasis staging:
✓. A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days plus an additional 120 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
✓. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
✓. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
Exclusion criteria
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dosing (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
. Has received 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, CD137).
✕. Has received any prior systemic anti-cancer therapy including investigational agents.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Has a known additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
✕. Has known active CNS metastases and/or carcinomatous meningitis.