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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous nivolumab 240mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03390738

First Posted

December 11, 2017

Last Updated

April 28, 2021

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03390738

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor withdrew funding for Nivolumab

Study Start Date

June 2018 (Anticipated)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous nivolumab 240mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

OPDIVO

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Toxicities as defined by CTCAE criteria

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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