Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03390738

Enrollment

Registered

2018-01-04

Start date

2018-06-30

Completion date

2019-06-30

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

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)

Interventions

DRUGNivolumab

Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria	1 year

Secondary

Measure	Time frame	Description
Toxicities as defined by CTCAE criteria	1 year	To characterize the safety and tolerability of nivolumab in subjects with recurrent/metastatic NPC. This will be based on subjects who experienced toxicities as defined by CTCAE criteria, receiving at least one dose of nivolumab.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026