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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pembrolizumab & MRG003
DrugAfter a screening phase of up to 28 days, each subject will be assigned to receive treatment until disease progression is confirmed, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, or until subjects has received up to 3 cycles pembrolizumab + MRG003, followed Standard concurrent chemoradiotherapy (CCRT), followed up to 14 cycles pembrolizumab.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Complete Response (cCR) rate
clinical complete response (cCR) rate to neoadjuvant treatment.
Time frame
cCR assessment will be performed on week 9±7 days between neoadjuvant therapy and pre CCRTSecondary outcomes
1
Objective Response Rate (ORR)
ORR, defined as the proportion of participants who have achieved a confirmed complete response (CR), or partial response (PR), which is assessed according to RECIST 1.1 criterial.
Time frame
To assess the objective response rate of Neoadjuvant therapy of Pembrolizumab in combination with MRG003 at maximum of 9 weeks (up to 3 cycles)2
Event-Free Survival (EFS)
To evaluate neoadjuvant therapy of Pembrolizumab in combination with MRG003 and adjuvant therapy of Pembrolizumab with respect to event-free survival (EFS).
Time frame
Defined as the time from date of treatment to the date of first documented disease progression that precluded definitive surgery, local or distant recurrence, occurrence of a second primary cancer or death from any cause, up to 36 months3
Overall Survival (OS)
To evaluate neoadjuvant therapy of Pembrolizumab in combination with MRG003 and adjuvant therapy of Pembrolizumab with respect to overall survival (OS).
Time frame
OS, defined as the time from the date of treatment to the date of death due to any cause, up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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