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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2024 |
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Main ID: |
NCT02289209 |
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Date of registration:
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17/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck
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Scientific title:
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A Phase II Trial of Reirradiation Combined With Open Label Pembrolizumab in Patients With Locoregional Inoperable Recurrence or Second Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
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Date of first enrolment:
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January 10, 2019 |
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Target sample size:
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51 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02289209 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Dan Zandberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UPMC Hillman Cancer Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Recurrent Head and Neck Cancer
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Carcinoma, Squamous Cell of Head and Neck
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Intervention(s)
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Radiation: Reirradiation
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Drug: MK-3475
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Primary Outcome(s)
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Progression free survival
[Time Frame: Up to 36 months (after starting reirradiation and MK-3475)]
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Secondary Outcome(s)
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Quality of life using EORTC QLQ-C30 and EORTC QLQ-H&N 35
[Time Frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)]
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Clinical Benefit Rate (CBR)
[Time Frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)]
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Overall Response Rate (ORR)
[Time Frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)]
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Overall survival (OS)
[Time Frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)]
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Time to in field disease progression
[Time Frame: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)]
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Secondary ID(s)
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HCC 18-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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