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

Sponsor
The University of Hong Kong (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03390738
Collaborator
(none)
0
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy
Anticipated Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intravenous nivolumab 240mg

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria [1 year]

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Dora Kwong, Clinical Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT03390738
    Other Study ID Numbers:
    • NPC-1501
    First Posted:
    Jan 4, 2018
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Carcinoma
    Nasopharyngeal Carcinoma
    Nivolumab

    Study Results

    No Results Posted as of May 3, 2021