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Tests treatment safety and results for Nasopharyngeal Cancinoma (NPC)
Official title Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07705243
What this study is testing
What is Anti-PD1?
Anti-PD1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This multicenter randomized controlled Phase III trial assesses the efficacy and safety of becotatug vedotin plus anti-PD-1 antibody as maintenance therapy for recurrent/metastatic nasopharyngeal carcinoma. Eligible patients aged 18-75 must have stable disease or positive plasma EBV DNA after 4-6 cycles of first-line chemoimmunotherapy, with adequate organ function and good physical status.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged between 18 and 75 years at diagnosis, regardless of gender;
- Histologically confirmed nasopharyngeal carcinoma;
- Patients with advanced nasopharyngeal carcinoma with confirmed distant metastasis (Stage IVb per AJCC 8th edition; Stage IV per AJCC 9th edition), or...
- Achieved stable disease (SD) assessed per RECIST v1.1 or maintained positive plasma EBV DNA after 4 to 6 cycles of first-line chemotherapy combined...
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
You likely can't join if
- Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0);
- History of hypersensitivity to any study drug;
- Expected survival less than 3 months;
- Active hepatitis B (positive HBsAg or HBcAb with HBV DNA ≥ 2000 IU/mL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower...
- Patients with positive HIV antibody;
- Active bacterial, fungal, viral infection requiring systemic treatment, or interstitial pneumonia within 1 week prior to the first administration of...
See the full eligibility criteria
- Aged between 18 and 75 years at diagnosis, regardless of gender;
- Histologically confirmed nasopharyngeal carcinoma;
- Patients with advanced nasopharyngeal carcinoma with confirmed distant metastasis (Stage IVb per AJCC 8th edition; Stage IV per AJCC 9th edition), or recurrent nasopharyngeal carcinoma unsuitable for locoregional or...
- Achieved stable disease (SD) assessed per RECIST v1.1 or maintained positive plasma EBV DNA after 4 to 6 cycles of first-line chemotherapy combined with immunotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival of at least 12 weeks;
- No prior systemic chemotherapy administered within 6 months before diagnosis (excluding patients with disease progression more than 6 months after neoadjuvant chemotherapy, adjuvant chemotherapy, or definitive...
- At least one measurable lesion as defined by RECIST v1.1;
- Adequate organ and bone marrow function as defined below:
- HGB ≥90 g/L, WBC ≥4×10⁹/L, PLT ≥100×10⁹/L.
- Liver function: TBIL \<1.5 × ULN; ALT and/or AST \<2.5 × ULN. For patients with liver metastases, ALT or AST \<5 × ULN. For patients with liver or bone metastases, ALP \<5 × ULN.
- Renal function: creatinine \<1.5 × ULN.
- Coagulation: INR of PT / PTT \<1.5 × ULN;
- Able to provide written informed consent and comply with all protocol-specified procedures including laboratory tests and follow-up visits;
- Female people of childbearing potential and male people with childbearing potential partners must agree to use effective contraception from screening through 6 months after the last dose of study treatment (e.g...
- Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0);
- History of hypersensitivity to any study drug;
- Expected survival less than 3 months;
- Active hepatitis B (positive HBsAg or HBcAb with HBV DNA ≥ 2000 IU/mL) or active hepatitis C (positive HCV antibody with HCV RNA above the lower limit of quantification at the study site). For patients with normal liver...
- Patients with positive HIV antibody;
- Active bacterial, fungal, viral infection requiring systemic treatment, or interstitial pneumonia within 1 week prior to the first administration of study drugs;
- Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval...
- Received anti-tumor therapies including chemotherapy, small-molecule inhibitors, immunotherapy (e.g., interleukins, interferons, thymosins) within 4 weeks or 5 half-lives (whichever is shorter, with a minimum interval...
- Underwent major surgery within 3 months prior to the first dose, or planned to receive major surgery during the study period;
- Severe thromboembolic events within 6 months before screening, such as cerebrovascular accidents (including transient ischemic attack) and pulmonary embolism;
- Active malignant tumors within 2 years prior to the first administration of study drugs, excluding nasopharyngeal carcinoma under investigation and any locally curable tumors that have received radical treatment (e.g...
- Severe cardiovascular diseases within 6 months before enrollment, including but not limited to:
- Acute myocardial infarction, unstable angina, coronary angioplasty or stenting, deep vein thrombosis, stroke;
- New York Heart Association (NYHA) Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 50%;
- Electrocardiogram (ECG) abnormalities of significant clinical relevance at screening as assessed by the investigator;
- Pregnant or breastfeeding women;
- Presence of any severe and/or uncontrolled diseases that, in the investigator's judgment, may interfere with the patient's participation in the study (including but not limited to uncontrolled diabetes...
- Any other conditions deemed inappropriate for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.