Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck

  • STATUS
    Recruiting
  • End date
    Dec 5, 2024
  • participants needed
    48
  • sponsor
    Dan Zandberg
Updated on 5 April 2022
squamous cell carcinoma
pembrolizumab
mk-3475
head and neck carcinoma

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®).

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.

Details
Condition Recurrent Head and Neck Cancer, Carcinoma, Squamous Cell of Head and Neck
Treatment MK-3475, Reirradiation
Clinical Study IdentifierNCT02289209
SponsorDan Zandberg
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have received only prior radiation treatment course. Prior radiation course must have
At least 6 months since completion of radiation
been with curative intent
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
Performance status of 0 or 1 on the ECOG Performance Scale
necessary
Life expectancy greater than 12 weeks
Have at least one measurable area of disease based on RECIST 1.1 within the previously
Adequate organ function as defined by the protocol
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

Exclusion Criteria

Presence of distant metastatic disease
Has an active autoimmune disease
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Has an active infection requiring systemic therapy
Is currently participating in or has participated in a study of an investigational
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
agent or used an investigational device within 4 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
Has received a live vaccine within 30 days prior to the first dose of trial treatment
other form of immunosuppressive therapy within 7 days prior to the first dose of trial
treatment
Has had a prior monoclonal antibody, chemotherapy, or targeted small molecule therapy
within 4 weeks prior to study Day 1 or who has not recovered from adverse events due
to agents administered more than 4 weeks earlier
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 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 known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected)
Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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