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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03390738
• Other study ID #: NPC-1501
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2018
• Est. completion date: June 2019

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria		1 year
Secondary	Toxicities as defined by CTCAE criteria	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.	1 year