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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy
ClinicalTrials.gov ID: NCT07496190
What this study is testing
What is Becotatug vedotin?
Becotatug vedotin is an investigational medicine, 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
- Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA \>0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival.
- Phase 2: a mid-size study of how well it works
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 70
You may be able to join if
- Voluntary participation and written informed consent must be signed.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
- how well it works after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and...
You likely can't join if
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- HIV positive.
- History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
See the full eligibility criteria
- Voluntary participation and written informed consent must be signed.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
- how well it works after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
- ECOG performance status score of 0 or 1.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010\^9/L, and Platele (PLT) ≥10010\^9/L.
- Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5\ ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \ ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the...
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- HIV positive.
- History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
- Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 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.