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

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Nivolumab

Criteria

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