NCT03390738WithdrawnPhase 2
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- The University of Hong Kong
- Primary Endpoint
- Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
Study Overview
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 platinum based chemotherapy)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Intravenous nivolumab 240mg
Experimental
Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal.
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
Time Frame: 1 year
Secondary Outcomes
- Toxicities as defined by CTCAE criteria(1 year)
Investigators
Professor Dora Kwong
Clinical Professor
The University of Hong Kong
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