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

Phase 2

Withdrawn

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nivolumab

• Registration Number: NCT03390738
• Lead Sponsor: The University of Hong Kong

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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-04
• Study Start: 2018-06
• Primary Completion: 2019-05
• Study Completion: 2019-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.