Actively Recruiting
A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo with Chemotherapy for Second-line or Later Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-02-05
300
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates treatment options for patients with recurrent or metastatic nasopharyngeal carcinoma who have not responded to first-line therapies. Researchers aim to compare the survival benefits, safety, and tolerability of AK104 combined with two chemotherapy regimens, GP or PFLL, against similar chemotherapy regimens combined with a placebo. This Phase II/III study is designed to evaluate how these combinations perform regarding progression-free survival over 24 months. Participants receive either AK104 or a placebo through intravenous infusion at a dose of 6 mg/kg over more than 60 minutes. The study includes four groups based on prior treatment exposure, with chemotherapy regimens consisting of 5-Fu and Cisplatin or Gemcitabine and Cisplatin administered in cycles every three weeks for up to six cycles. AK104 or placebo infusions are given on specific days within each cycle, followed by maintenance doses every two weeks after chemotherapy. During the trial, participants undergo regular assessments including imaging to measure tumor response according to RECIST1.1 criteria, and evaluations of vital organ function and overall health status. Tissue samples collected within three years prior to enrollment are required. Researchers will monitor progression-free survival as the primary outcome and track safety and tolerability throughout the study, which lasts until at least 24 months after treatment begins.
CONDITIONS
Brief Title
A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Pathologically confirmed non-keratinized differentiated or undifferentiated nasopharyngeal carcinoma
- Recurrent or metastatic disease not eligible for local treatment as defined by standard staging systems
- Failure of first-line treatment for nasopharyngeal carcinoma
- ECOG performance status of 0 or 1
- At least one measurable lesion by RECIST1.1 criteria
- Available tissue samples from within three years prior to enrollment
- Expected survival of at least 3 months
- Adequate vital organ function including neutrophil count, platelets, hemoglobin, serum albumin, liver enzymes, and creatinine clearance
- Use of effective birth control for women of reproductive age and unsterilized men during and after treatment
- Signed informed consent
You will not qualify if you...
- Allergy to 5-Fu, cisplatin, gemcitabine, monoclonal antibodies, or components of CTLA-4 and PD1 bispecific antibodies
- Major surgery within 28 days before randomization or planned major surgery during the study
- Active or history of autoimmune diseases requiring treatment, except certain stable conditions
- Use of immunosuppressants or systemic steroids above specified doses within 2 weeks before enrollment
- Allergy to macromolecular protein preparations or AK104 ingredients
- Symptomatic central nervous system metastases or active brain metastases
- Other aggressive malignancies within 7.5 years except certain curable skin and superficial cancers
- Active infections requiring systemic treatment or serious infections recently
- Untreated or active hepatitis B or C not meeting stability criteria
- Meningeal metastasis, uncontrolled effusions needing drainage
- Unresolved toxicity from previous antitumor therapy above specified grades
- Live attenuated vaccines within 30 days before starting treatment
- Pregnant or breastfeeding women
- Uncontrolled heart conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Known history of substance abuse or other serious illnesses affecting safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks for initial chemotherapy cycles; continuation treatment duration varies
Participants receive up to 6 cycles of chemotherapy combined with either AK104 or placebo. Each cycle lasts 3 weeks. After completing 6 cycles, participants may continue to receive AK104 or placebo every 2 weeks.
Visits every 1 to 3 weeks during treatment cycles, then every 2 weeks during continuation
Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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