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Reirradiation With MK-3475 in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck
Conditions
Recurrent Head and Neck Cancer - Carcinoma, Squamous Cell of Head and Neck
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
head and neck cancer, reirradiation, MK-3475, Anti-PD-1 monoclonal antibody, Squamous cell carcinoma, Keytruda, pembrolizumab
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Reirradiation
Type: Radiation
Name: MK-3475
Type: Drug
Overall Status
Recruiting
Summary
Eligible participants with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).
Detailed Description
Each participant will undergo screening and then be treated with reirradiation with 1.2 Gy BID, 5 days a week (weeks 1-5). MK-3475 (generic name: pembrolizumab, trade name Keytruda®) will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued in all participants until 3 months post completion of reirradiation, at which time a PET/CT will be done to evaluate response. Participants with progressive disease (PD) will be taken off MK-3475 and followed for survival. Participants that have a complete response (CR) will be followed clinically and radiographically, and if disease recurs may be eligible to be retreated with MK-3475 for up to one year. Participants with partial response (PR) or stable disease (SD) will continue treatment with MK-3475 for up to two years unless one of the following occurs:
- documented disease progression
- unacceptable adverse event(s)
- intercurrent illness that prevents further administration of treatment
- investigator decision to withdraw the subject
- withdrawal of consent
- pregnancy
- noncompliance
- administrative reasons (i.e. trial is closed prematurely).
Participants who have not progressed at completion of 24 months of therapy will be observed, but may be eligible for 1 year of retreatment with MK-3475 if they develop recurrence/progression and qualify for retreatment as detailed in the protocol,and if the trial is still ongoing.
- documented disease progression
- unacceptable adverse event(s)
- intercurrent illness that prevents further administration of treatment
- investigator decision to withdraw the subject
- withdrawal of consent
- pregnancy
- noncompliance
- administrative reasons (i.e. trial is closed prematurely).
Participants who have not progressed at completion of 24 months of therapy will be observed, but may be eligible for 1 year of retreatment with MK-3475 if they develop recurrence/progression and qualify for retreatment as detailed in the protocol,and if the trial is still ongoing.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Locoregional inoperable recurrent or second primary squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
- Have had only one prior course of radiation therapy with a curative intent and it has been at least 6 months since completion of radiation
- Based on prior radiation records, have had most of the tumor volume (>50%) previously radiated at doses > 45 Gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of < 50 Gy).
- Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if necessary.
- Have at least one measurable area of disease based on RECIST 1.1 within the previously radiated field.
- Have provided adequate tissue for PD-L1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. Archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial.
- Performance status of 0 or 1 on the ECOG Performance Scale.
- Life expectancy greater than 12 weeks
- Adequate organ function based on laboratory results
Exclusion Criteria:
- Presence of distant metastatic disease.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- History of other malignancy within 5 years with the exception of prior Squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
- Has an active autoimmune disease
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Is pregnant or breastfeeding.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to the first dose of trial treatment
- Locoregional inoperable recurrent or second primary squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx)
- Have had only one prior course of radiation therapy with a curative intent and it has been at least 6 months since completion of radiation
- Based on prior radiation records, have had most of the tumor volume (>50%) previously radiated at doses > 45 Gy without exceeding spinal cord tolerance (combining previous and future radiation dose to spinal cord of < 50 Gy).
- Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if necessary.
- Have at least one measurable area of disease based on RECIST 1.1 within the previously radiated field.
- Have provided adequate tissue for PD-L1 analysis either from an archival tissue sample or fresh biopsy done to confirm recurrence/second primary. Archival tissue sample can only be used if done within 3 months of enrollment on the clinical trial.
- Performance status of 0 or 1 on the ECOG Performance Scale.
- Life expectancy greater than 12 weeks
- Adequate organ function based on laboratory results
Exclusion Criteria:
- Presence of distant metastatic disease.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- History of other malignancy within 5 years with the exception of prior Squamous cell carcinoma of the head and neck, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix.
- Has an active autoimmune disease
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Is pregnant or breastfeeding.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to the first dose of trial treatment
Location
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Jagdish Shetty, MPH - 410-328-7680 - jshetty@umm.edu
Start Date
December 2014
Completion Date
December 2018
Sponsors
Dan Zandberg
Source
University of Maryland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page