Clinical Trials Logo
  1. Home
  2. Nasopharyngeal Carcinoma
  3. NCT03097939

Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
A Phase II Trial Of Ipilimumab In Combination With Nivolumab In Patients With Advanced Nasopharyngeal Carcinoma

Clinical Trial Summary

The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO) strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC). Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV) driven nasopharyngeal carcinoma.

Clinical Trial Description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and South-east Asia. Due to the peculiar chemosensitive nature of this disease and the low investment in drug development in Asia, there has been a paucity of new therapies for this disease. While response rates to repeated lines of chemotherapy average around 30%, the duration of disease control remains dismal and hence there is an unmet need to develop new therapies for this disease. These response rates are fairly similar to current monotherapy use of anti-PD1 agents in this group. Of specific interest, combined IO strategies have appear to add significantly to response rates in selected tumors such as melanoma, small cell lung cancer, and now Epidermal Growth Factor Receptor (EGFR) mutant lung cancers. It is hypothesized that a combined IO strategy would have similar if not better responses in a virally driven cancer like NPC. Hence this is a single arm study exploring the activity of a combination of nivolumab and ipilimumab in EBV driven nasopharyngeal carcinoma (NPC). The primary endpoint is best overall response rate. Secondary endpoints will examine clinical benefit rate at 18 weeks, toxicities of the combination, and immunological correlates. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03097939
Study type Interventional
Source National Cancer Centre, Singapore
Contact Darren, Wan-Teck Lim, MD
Phone +65 6436 8000
Email darren.lim.w.t@singhealth.com.sg
Status Recruiting
Phase Phase 2
Start date March 31, 2017
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05979961 - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT06055816 - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Phase 2
Recruiting NCT05547971 - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting NCT05020925 - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 1/Phase 2
Not yet recruiting NCT04547088 - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Not yet recruiting NCT04548271 - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02795169 - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02801487 - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02569788 - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT02237924 - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02044562 - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients N/A
Terminated NCT01694576 - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation Phase 2
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01271439 - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma Phase 2
Completed NCT00535795 - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA Phase 3
Completed NCT00379262 - Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma Phase 3
Completed NCT03398980 - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy N/A
Completed NCT01309633 - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC) Phase 2