Clin2
NCT07783321Possibly a fitNot yet recruiting

Immunotherapy with or without BL-B01D1 for nasopharyngeal cancer

Nasopharyngeal Carcinoma (NPC)

Treatments studied

Part of Cancer, Ear, nose & throat, Mouth & dental clinical trials.

This study tests whether adding an experimental drug (BL-B01D1) to a standard immunotherapy (anti-PD-1 antibody) as maintenance therapy is better than immunotherapy alone for patients with nasopharyngeal cancer that has spread or come back. The goal is to see if the combination helps keep the cancer from growing longer.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
414 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years or older.
  • You must have nasopharyngeal cancer that is either newly diagnosed with spread (stage IV) or has come back after prior treatment with curative intent.
  • You must have at least one tumor that can be measured on imaging scans.
  • Your overall health status (ECOG score) must be 0 or 1, meaning you are fully active or restricted only in physically strenuous activity.
  • You must agree to provide a tumor tissue sample (from a biopsy or surgery) for testing.
  • You must not have had prior systemic treatment for your nasopharyngeal cancer (except for the treatment you received as part of the initial curative approach).
  • You must not have had a prior cancer (other than nasopharyngeal) in the last 3 years.
  • You must not have active brain metastases, severe heart or lung disease, or poorly controlled blood pressure or diabetes.
  • You must not be pregnant or breastfeeding, and if you are of childbearing potential, you must use highly effective birth control during the study and for 7 months after the last dose.
  • Your blood, liver, and kidney function must meet certain lab criteria (tested by the study team).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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