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Trial record 7 of 67 for:    tpn

Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT03894891
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute

Brief Summary:
This research is being performed to treat patient for head and neck cancer patients who have not received prior chemotherapy.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Nivolumab Drug: Cisplatin Drug: Docetaxel Radiation: Radioimmunotherapy Phase 2

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug or combination of interventions is being studied.

Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or advanced head and neck cancer (head and neck cancer that has come back or is incurable) but is considered investigational for head and neck cancer patients who have not received prior chemotherapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Therapy With Induction TPN Followed by Nivolumab With Radiation in Locoregionally Advanced Laryngeal and Hypopharyngeal Cancer
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Docetaxel+Cisplatin+Nivolumab+Radioimmunotherapy
Docetaxel will be administered per standard institutional every 3 weeks Nivolumab will be administered intravenously every 3 weeks Cisplatin will be administered intravenously every 3 weeks Radioimmunotherapy will be conducted 3 weeks after the last cycle of TPN (docetaxel, cisplatin and nivolumab)
Drug: Nivolumab
Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer
Other Name: OPDIVO®

Drug: Cisplatin
Cisplatin is a chemotherapy medication used to treat a number of cancers
Other Name: Platinol

Drug: Docetaxel
Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck
Other Name: Taxotere

Radiation: Radioimmunotherapy
Radiation Therapy to shrink or kill tumors.
Other Name: RT




Primary Outcome Measures :
  1. Laryngectomy-free survival [ Time Frame: 2 years ]
    To improve efficacy with respect to laryngectomy-free survival (LFS) at 2-years from time of study registration as the primary endpoint.


Secondary Outcome Measures :
  1. Quality of life Measure, QLQ-C30 [ Time Frame: 2 years ]
    General "Quality of Life" or QOL will be assessed via a self-reported questionnaire at the timepoints outlined in the Study Calendar. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) contains 30 questions belonging to five functional scales, nine symptom scales, financial difficulty, and one global health status (quality of life) scale. The responses are graded on a scale of 1 to 4, where 1 is "not at all" and 4 is "very much".

  2. Quality of life Measure, QLQ-H&N35 [ Time Frame: 2 years ]
    "Quality of Life" or QOL specifically related to head and neck cancer will be assessed via a self-reported questionnaire at the timepoints outlined in the Study Calendar. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-H&N35) will be used to evaluate the reliability and validity of a new, disease-specific quality of life measure for patients with head and neck cancer: This questionnaire contains 35 questions with responses on a scale of 1 to 4, where 1 is "not at all" and 4 is "very much".

  3. Overall Survival [ Time Frame: 2 years ]
    Overall Survival (OS) is defined as the time from study registration to death due to any cause, otherwise, participants are censored at date last known alive.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have histologically or cytologically confirmed, resectable or unresectable, Stage III or Stage IV locoregionally advanced squamous cell carcinoma of the larynx or hypopharynx, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition
  • Willing to provide tissue from diagnostic biopsy and blood samples before, during, and after treatment
  • Any smoking history is permitted
  • Patients must have HPV negative disease. Those patients with a supraglottic primary are required to undergo HPV testing with p16 immunohistochemistry and/or confirmatory HPV PCR or ISH testing to rule out oropharyngeal origin with laryngeal extension
  • Age 18 years or older
  • ECOG performance status ≤ 1 (Karnofsky ≥ 80%, see Appendix A)
  • Participant must have normal organ and marrow function as defined below within 21 days prior to study registration:

    • leukocytes ≥3,000/mcL
    • absolute neutrophil count ≥1,500/mcL
    • platelets ≥100,000/mcL
    • total bilirubin ≤2.0 g/dL
    • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
  • Ability to understand and the willingness to sign a written informed consent document
  • Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP should plan to use an adequate method to avoid pregnancy for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of nivolumab
  • Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
  • Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception

Exclusion Criteria:

  • Existing severe autoimmune conditions (at the discretion of the treating physician). Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded. Short-term corticosteroid dosing is permitted (i.e. dexamethasone for chemotherapy-induced nausea prevention during induction chemotherapy) as long as steroids are discontinued within 1 week (7 days) of receiving the first dose of nivolumab during the induction phase of treatment.
  • Subject who has had prior chemotherapy for head and neck cancer and/or radiotherapy to the head and neck.
  • Subject who has been treated with immunotherapy. This includes prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • 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.
  • Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
  • Known non-infectious pneumonitis or any history of interstitial lung disease.
  • 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, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 5 years is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894891


Contacts
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Contact: Robert Haddad, MD 617-632-5260 robert_haddad@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Robert Haddad, MD    617-632-5260    robert_haddad@dfci.harvard.edu   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Investigators
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Principal Investigator: Robert Haddad, MD Dana-Farber Cancer Institute

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Responsible Party: Robert I. Haddad, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03894891     History of Changes
Other Study ID Numbers: 18-652
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert I. Haddad, MD, Dana-Farber Cancer Institute:
Head and Neck Cancer

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Hypopharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Docetaxel
Nivolumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological