Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11

Sponsor
Seoul National University Hospital
Study ID
NCT06440187
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent or Metastatic Nasopharyngeal Carcinom

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. At present, cisplatin plus continuous intravenous infusion of fluorouracil is widely used in patients with recurrent or metastatic nasopharyngeal carcinoma, with a response rate of 40-65%. Gemcitabine single is active and tolerable agent for recurred or metastatic NPC. Response rate (RR) was 34% and progression-free survival (PFS) was 5.0 months . Moreover, gemcitabine reduces the frequency of CD11b+GR1+ myeloid suppressor cells. Gemcitabine-induced apoptosis of established tumours may enhance the dendritic cell dependent cross-presentation of tumor antigens to T cells. Gemcitabine can function in synergy with CD40 stimulation of T cells. Hence, theoretically gemcitabine can have synergistic effect with PD-1/PD-L1 blocking agent. Immunotherapy with immune checkpoint inhibitors has gradually emerged as a promising treatment modality for head and necks squamous cell carcinoma and NPC.

Key Dates

Start date
Jun 8, 2018
Status verified
May 2024
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: gemcitabine+ nivolumab
    Nivolumab administration on D1 and D15 every cycle, with 3mg/kg with gmecitabine co-administration on D1 and D15 every cycle, with 1250mg/m2

Primary Outcome Measure

Progression free survival [ Time Frame: From the first date of treatment to the date occurring disease progression or death from any cause ]