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

NCT ID: NCT03390738

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2019-06-30

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)

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous nivolumab 240mg

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

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

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

Interventions

Nivolumab

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

Intervention Type: DRUG

Other Intervention Names

OPDIVO

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Dora Kwong

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NPC-1501

Identifier Type: -

Identifier Source: org_study_id