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

NCT03390738 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: NPC-1501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria

  1 year

Secondary Outcomes (1)

• Toxicities as defined by CTCAE criteria

  1 year

Study Arms (1)

Intravenous nivolumab 240mg

EXPERIMENTAL

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

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Also known as: OPDIVO

Intravenous nivolumab 240mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 4, 2018
• Study Start: June 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 3, 2021

Record last verified: 2021-04