Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer
Multicenter Phase II Study of Nivolumab in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
7 other identifiers
interventional
45
3 countries
19
Brief Summary
This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 15, 2015
CompletedStudy Start
First participant enrolled
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2018
CompletedResults Posted
Study results publicly available
September 13, 2019
CompletedSeptember 13, 2019
August 1, 2019
2.9 years
January 12, 2015
August 16, 2019
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Confirmed Response Rate (Complete Response or Partial Response) Based on RECIST Version 1.1
Confirmed response rate is defined as either a Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1. \> To be consider a CR, there must be a disappearance of all target lesions and each target lymph node must have reduction in short axis to \< 1.0 cm.\> \> To be considered a PR, at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline value.\> \> The confirmed response rate is reported as the number of patients reporting a CR or PR divided by the total number of evaluable patients multiplied by 100 (reported as a percentage).
Up to 3 years
Secondary Outcomes (5)
Adverse Events
Up to 3 years on treatment
Tumor Response to Nivolumab Based on the Immune Response Criteria (IRC)
Up to 3 years
Duration of Response
Up to 3 years
Progression-free Survival (PFS) Based on RECIST Version 1.1
Time from registration to the first of either death due to any cause or progression, assessed up to 3 years
Overall Survival (OS)
Time from registration to death due to any cause, assessed up to 3 years
Other Outcomes (5)
Clearance of EBV DNA
Up to 6 weeks of treatment
Intratumoral Expression of PD-1 and PD-L1
Baseline
Change in Serum Absolute Lymphocyte Count
Baseline and up to 3 years
- +2 more other outcomes
Study Arms (1)
Treatment (nivolumab)
EXPERIMENTALPatients receive nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign a written informed consent document
- Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at locoregional and/or distant sites; NOTE: patients with local recurrence at the bony skull-base as the only site of index disease are excluded; patients with locoregional recurrence without distant metastases must have undergone radical radiotherapy previously
- Measurable disease according to the RECIST criteria (version 1.1), for the evaluation of measurable disease
- Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery
- Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Absolute neutrophil count \>= 1.5 x 10\^9/L
- Platelet count \>= 100 x 10\^9/L
- Hemoglobin \>= 8.0 g/dL
- Serum alanine aminotransferase (\[ALT\]; serum glutamate-pyruvate transferase \[SGPT\]), or serum aspartate aminotransferase \[AST\] where available at the center) \< 2.5 x upper limit of normal (ULN), OR \< 5 x ULN in the presence of liver metastases
- Serum total bilirubin \< 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL)
- Serum creatinine \< 1.5 x ULN
You may not qualify if:
- Any of the following:
- Chemotherapy =\< 4 weeks prior to registration
- Radiotherapy =\< 4 weeks prior to registration
- Nitrosoureas =\< 6 weeks prior to registration or
- Mitomycin C =\< 6 weeks prior to registration
- Those who have not recovered from adverse events (to grade =\< 1 in severity) due to agents administered more than 4 weeks earlier; prior palliative radiotherapy to bone metastases =\< 2 weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed \> 2 weeks prior to registration)
- Prior investigational agents =\< 4 weeks prior to registration
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Known brain metastases or leptomeningeal metastases; NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. \> 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =\< 8 weeks of study entry, are not excluded; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
- History of severe hypersensitivity reaction to any monoclonal antibody
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any of the following:
- Pregnant women
- Nursing women
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Mayo Clinic Cancer Center P2C
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China
National University Hospital Singapore
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Johns Hopkins Singapore
Singapore, 308433, Singapore
Related Publications (1)
Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.
PMID: 29584545DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brigette B.Y. Ma
- Organization
- Prince of Wales Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Brigette B Ma
Mayo Clinic Cancer Center P2C
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 15, 2015
Study Start
July 21, 2015
Primary Completion
June 16, 2018
Last Updated
September 13, 2019
Results First Posted
September 13, 2019
Record last verified: 2019-08