Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally A… (NCT07524413) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
514 participantsStarted 2026-04
Plain-language summary
This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age ≥ 18 years at the time of diagnosis, regardless of sex
2\. Histologically confirmed newly diagnosed nasopharyngeal carcinoma (NPC) of non-keratinizing carcinoma histology (WHO classification)
3\. Locoregionally advanced NPC staged as T4N2 or T1-4N3 according to the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) 9th edition staging system. All patients must undergo the following evaluations prior to initiation of any treatment to confirm clinical staging: complete medical history and physical examination, complete blood count (CBC) and biochemistry panel, plasma Epstein-Barr virus (EBV) DNA titer and serology, nasopharyngoscopy, magnetic resonance imaging (MRI) of the head and neck, chest X-ray or computed tomography (CT) of the chest, abdominal ultrasound, and bone scintigraphy. 18F-fluorodeoxyglucose positron emission tomography/CT (¹⁸F-FDG PET/CT) may be used as a substitute for the latter three imaging modalities.
4\. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
5\. Willing to provide archived tumor tissue (primary or metastatic lesion, obtained within 2 years prior to enrollment) or fresh biopsy specimen. Patients unable to provide tumor tissue may still be enrolled at the investigator's discretion, provided all other eligibility criteria are met.
6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.