Status:
WITHDRAWN
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
Lead Sponsor:
The University of Hong Kong
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include plat...
Eligibility Criteria
Inclusion
- Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy
- Measurable disease (RECIST 1.1)
- ECOG 2 or less
- Life expectancy greater than 3 months
- Adequate organ function
- (Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged
Exclusion
- Suitable for local therapy
- Did not have prior platinum chemotherapy
- Immunodeficiency; immunosuppressive treatment
- Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1
- Other cancer treatment within 2 weeks prior to Day 1
- Other malignancies (some exceptions)
- CNS metastases; carcinomatous meningitis
- Active temporal lobe necrosis or on steroid treatment
- Autoimmune disease
- Active, non-infectious pneumonitis
- Active infection requiring systemic treatment
- Hepatitis
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03390738
Start Date
June 1 2018
End Date
June 1 2019
Last Update
May 3 2021
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