Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440187
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2018-06-06
Brief Title:
Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Phase II Study of Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HN17-11
Brief Summary:
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 50 months Moreover gemcitabine reduces the frequency of CD11bGR1 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-1PD-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
Gemcitabine single is active and tolerable agent for recurred or metastatic NPC Response rate RR was 34 and progression-free survival PFS was 50 months Moreover gemcitabine reduces the frequency of CD11bGR1 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-1PD-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
Detailed Description:
Based on these evidences which suggest a function for PD-1PD-L1 in NPC and potential synergistic effect with gemcitabine the use of nivolumab in recurredmetastatic NPC is reasonable and valuable So we design this phase II study of nivolumab and gemcitabine in recurredmetastatic NPC which is common cancer in Asian
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None