Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07267338

Pembrolizumab + MRGOO3 as Neoadjuvant in NPC

Conditions: NPC, Locoregionally Advanced Nasopharyngeal Carcinoma

Sex: All
Healthy volunteers: No
Phase: PHASE2
Enrollment: 35
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Location: Wuhan Xiehe Hospital Wuhan Hubei

Summary

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

Inclusion Criteria: 1. 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. 2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 3. 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. 4. 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. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. 6. Epsitein-Barr virus-encoded RNA(EBER) positive. 7. Epidermal Growth Factor Receptor (EGFR) positive. 8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. 9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. 10. Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention. Exclusion Criteria: 1. Presence of any distant metastasis. 2. 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). 3. 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 \[allocation\]. 4. 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. 5. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. 7. 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. 8. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07267338). StuddyBuddy aggregates publicly available trial information.