Clinical trial · Interventional
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
NCT03390738CI-TRIAL-00051568withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor withdrew funding for Nivolumab
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous nivolumab 240mg
- description
- Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal.
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Toxicities as defined by CTCAE criteria
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.