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Trial Title:
Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck
NCT ID:
NCT02289209
Condition:
Recurrent Head and Neck Cancer
Carcinoma, Squamous Cell of Head and Neck
Conditions: Official terms:
Carcinoma
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Recurrence
Pembrolizumab
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
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Reirradiation
Description:
Reirradiation 1.2 GY BID 5 days a week for 5 weeks.
Arm group label:
Reirradiation + MK-3475
Intervention type:
Drug
Intervention name:
MK-3475
Description:
MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of
reirradiation and will be continued once every 3 weeks until 3 months post completion of
reirradiation. Further continuation of MK-3475 will be determined by response evaluation
at 3 months post completion of reirradiation
Arm group label:
Reirradiation + MK-3475
Other name:
Keytruda, pembrolizumab
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.
Criteria for eligibility:
Criteria:
Patients with biopsy proven locoregional recurrence or second primary SCCHN which is
unresectable or the patient is unwilling to undergo resection. Determination of
unresectability will be based on multidisciplinary review of each case.
Inclusion Criteria:
1. Have received only prior radiation treatment course. Prior radiation course must
have been with curative intent.
2. At least 6 months since completion of radiation
3. 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).
4. Be willing to undergo percutaneous endoscopic gastrostomy (PEG) placement, if
necessary.
5. Have at least one measurable area of disease based on RECIST 1.1 within the
previously radiated field.
6. 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.
7. Performance status of 0 or 1 on the ECOG Performance Scale.
8. Life expectancy greater than 12 weeks
9. Adequate organ function as defined by the protocol
Exclusion Criteria:
1. Presence of distant metastatic disease.
2. Is currently participating in or has participated in a study of an investigational
agent or used an investigational device within 4 weeks of the first dose of
treatment.
3. 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.
4. 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.
5. 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.
6. Has an active autoimmune disease
7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
8. Has an active infection requiring systemic therapy
9. 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).
10. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
11. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
12. Has received a live vaccine within 30 days prior to the first dose of trial
treatment
13. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Univeristy of Maryland - Greenebaum Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Start date:
January 10, 2019
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Dan Zandberg
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02289209