Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
NCT06241599

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)

Led by Sun Yat-sen University · Updated on 2024-02-05

300

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To compare whether AK104 combined with GP or PFLL can improve survival benefit, safety and tolerability in nasopharyngeal carcinoma patients who have failed first-line treatment; To compare the survival benefits of GP or GFLL treatment in nasopharyngeal carcinoma patients who had failed first-line therapy; To compare the survival benefits of GP or GFLL combined with AK104 in patients with nasopharyngeal carcinoma who had failed first-line therapy.

CONDITIONS

Official 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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Pathologically confirmed non-keratinized differentiated or undifferentiated nasopharyngeal carcinoma
  • Recurrent or metastatic disease not suitable for local treatment as defined by UICC/AJCC staging
  • Failed first-line treatment for nasopharyngeal carcinoma
  • ECOG performance score 0 or 1
  • At least one measurable lesion per RECIST 1.1 criteria
  • Provided tissue samples within three years before enrollment
  • Expected survival of at least 3 months
  • Adequate vital organ function with specific blood count and chemistry parameters
  • Women of reproductive age with unsterilized partners must use effective birth control
  • Unsterilized men with partners of childbearing age must use effective birth control from day 1 to day 120 after last study drug use
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Allergy to 5-Fu, cisplatin, gemcitabine, monoclonal antibodies, or components of CTLA-4 and PD1 bispecific antibodies
  • Prior simultaneous CTLA-4 and PD1-specific antibody therapy
  • Major surgery within 28 days before randomization or planned during study
  • Active or history of autoimmune disease requiring treatment, except certain controlled conditions
  • Use of immunosuppressants or systemic/absorbed local steroids above specified doses within 2 weeks before enrollment
  • Allergy to macromolecular protein preparations
  • Symptomatic central nervous system metastases
  • Other aggressive malignancies within 7.5 years except certain localized cancers
  • Active autoimmune disease requiring systemic treatment within 2 years except specified conditions
  • Active or past inflammatory bowel disease
  • Glucocorticoid or immunosuppressant therapy required within 7 days of investigational drug start
  • Allogeneic organ or stem cell transplantation
  • Gastrointestinal perforation or fistula within 6 months before enrollment
  • Necrotic foci posing major bleeding risk within 4 weeks before enrollment
  • History of interstitial pneumonia or active tuberculosis
  • Serious infections within 4 weeks before investigational drug use
  • Active infections requiring systemic treatment
  • Untreated chronic hepatitis B or high HBV DNA load or active hepatitis C
  • Major surgery within 30 days before investigational drug
  • Meningeal or active brain metastasis
  • Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
  • Unresolved toxicity from prior cancer therapy above specified levels
  • Live attenuated vaccine within 30 days before investigational drug or planned during study
  • Severe allergy to other monoclonal antibodies
  • Pregnant or breastfeeding women
  • Uncontrolled heart conditions including heart failure NYHA 2 or above, unstable angina, recent myocardial infarction, or serious arrhythmias
  • Active infection or unexplained fever above 38.5°C at screening
  • Allergy to AK104 ingredients
  • History of substance abuse
  • Other serious illnesses or conditions that may affect study participation or safety as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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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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