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Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT02875613
Recruitment Status : Terminated (Slow patient accrual)
First Posted : August 23, 2016
Results First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Assuntina Sacco, M.D., University of California, San Diego

Tracking Information
First Submitted Date  ICMJE August 18, 2016
First Posted Date  ICMJE August 23, 2016
Results First Submitted Date  ICMJE August 15, 2019
Results First Posted Date  ICMJE September 5, 2019
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
Overall Response Rate [ Time Frame: 6 months ]
Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Overall Response Rate [ Time Frame: 6 months ]
Based on RECIST criteria
Change History Complete list of historical versions of study NCT02875613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Avelumab for Recurrent/Metastatic Nasopharyngeal Cancer
Official Title  ICMJE An Open-label, Single-arm, Multi-institutional Phase II Trial of Avelumab for Recurrent, Metastatic Nasopharyngeal Carcinoma
Brief Summary The purpose of this study is to determine whether avelumab, an investigational antibody against programmed death-ligand (PD-L1), has an effect on recurrent nasopharyngeal cancer. Avelumab is designed to block the interaction between programmed cell death protein 1 (PD-1), a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
Detailed Description

This is a prospective, multi-center, open-label, single-arm phase II trial to evaluate the efficacy of Avelumab for patients with recurrent/metastatic, Epstein-Barr virus (EBV)-related nasopharyngeal carcinoma.

Upon study entry, all patients will receive Avelumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal. Dose interruptions may occur per pre-specified criteria for grade 3 or higher toxicity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Cancer
Intervention  ICMJE Drug: Avelumab
Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.
Other Name: MSB0010718C
Study Arms  ICMJE Experimental: Avelumab
Avelumab 10mg/kg IV infusion on days 1 and 15 of 28-day cycle
Intervention: Drug: Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 15, 2019)
6
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
39
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has histologically/cytologically confirmed, non-keratinizing/undifferentiated, EBV-related nasopharyngeal carcinoma, not amenable to curative intent therapy. EBV testing may be completed per institutional standards.
  • Patient must have at least one measurable site of disease as defined by RECIST v1.1, determined by investigator review
  • Patient has received at least one prior line of systemic therapy in the recurrent/metastatic setting
  • Patient is willing to undergo a fresh tumor biopsy (core or excisional) for correlative analyses (ie. PD-L1 expression).The study chair may grant exceptions to the mandatory biopsy should the treating physician deem that a biopsy is not feasible or unsafe for the patient, and archival tissue is available and provided for study purposes. A conversation with the study chair is required to obtain an exception.
  • Patient has adequate organ and marrow function.
  • Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication

Exclusion Criteria:

  • Patient is currently receiving or has received another investigational agent within 4 weeks prior to Day 1 of study.
  • Patient has received chemotherapy or radiotherapy within 4 weeks prior to Day 1 of study. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been radiated.
  • Patient has received prior immunotherapy with inhibitors of PD-1/PD-L1 axis.
  • Patient has had major surgery or insufficient recovery from surgical-related trauma or wound healing within 14 days of Study Day 1.
  • Patient has had a prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1.
  • Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Patient has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patient has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy (>10mg prednisone daily, or steroid equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of avelumab.
  • Patient has a known history of active TB (Bacillus Tuberculosis).
  • Patient has a known history of, or any evidence of active, non-infectious pneumonitis.
  • Patient has a known history of chronic interstitial lung disease.
  • Patient has an active infection requiring systemic therapy.
  • Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Patient has known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV). Patients with HIV who have a normal CD4 count (≥ 200) and an undetectable viral load are not excluded.
  • Patient has received a live vaccine within 30 days of study Day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02875613
Other Study ID Numbers  ICMJE 160114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assuntina Sacco, M.D., University of California, San Diego
Study Sponsor  ICMJE Assuntina Sacco, M.D.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Assuntina Sacco, MD University of California Medical Center
PRS Account University of California, San Diego
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP