Pembrolizumab + MRGOO3 as Neoadjuvant in NPC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
The goal of this clinical trial is to evaluate efficacy and safety of neoadjuvant of the anti PD1 agent Pembrolizumab combined with MRG003 and adjuvant treatment of Pembrolizumab in patients with Epstein-Barr virus (EBV) - associated locoregionally advanced nasopharyngeal carcinoma.
The expected sample size is 35 patients.
Participants will receive 3 cycles of neoadjuvant pembrolizumab 200mg Q3W plus MRG003 2.3mg/kg Q3W followed by the standard concurrent chemoradiotherapy. Then participants will receive 14 cycles of adjuvant Pembrolizumab 200 mg Q3W after the standard concurrent chemoradiotherapy.
The estimated average length of treatment per patients is 1 year.
Eligibility criteria
Qualifiers
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of stage III-IVa (Exclude T3N0) nasopharyngeal carcinoma (NPC) will be enrolled in this study.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Archival tumor tissue sample or newly obtained [core or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide. Newly obtained biopsies are preferred to archived tissue.
Disqualifiers
Presence of any distant metastasis.
Has received prior therapy with EGFR target therapy, or 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 prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [allocation].
Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Trial design
Treatments tested in this trial
- Pembrolizumab & MRG003
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Lepu Medical Technology (Beijing) Co., Ltd.
Collaborator
Source ClinicalTrials.gov