EUCTR2017-003636-36-GB
Active, not recruiting
Phase 1
A phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status 2 with recurrent or metastatic squamous cell carcinoma of the head and neck - POPPY
niversity College London0 sites65 target enrollmentSeptember 12, 2018
ConditionsRecurrent/metastatic head and neck squamous cell cancerMedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Recurrent/metastatic head and neck squamous cell cancer
- Sponsor
- niversity College London
- Enrollment
- 65
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies.
- •2\. Measurable disease evaluated by RECIST v1\.1
- •3\. WHO performance status of 2
- •4\. Life expectancy of at least 12 weeks
- •5\. Aged \= 18 years of age
- •6\. Adequate bone marrow function:
- •\- Absolute neutrophils \= 1\.5 × 109/L
- •\- Platelets \= 100 x 109/L
- •\- Haemoglobin \= 90 g/L
- •7\. Adequate renal function:
Exclusion Criteria
- •1\. Patients with undifferentiated nasopharyngeal or sino\-nasal cancers
- •2\. Disease suitable for treatment with curative intent
- •3\. Prior therapy with an anti\-PD\-1, anti\-PD\-L1 or anti\-PD\-L2 agent
- •4\. Any investigational agents within 4 weeks prior to registration
- •5\. Anti\-cancer monoclonal antibody therapy within 4 weeks prior to registration
- •6\. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
- •7\. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- •8\. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre\-screening or screening visit through 120 days after the last dose of trial treatment
- •9\. Grade 3 or 4 peripheral neuropathy
- •10\. Any serious and/or unstable pre\-existing medical, psychiatric or other condition that, in the treating clinician’s judgment, could interfere with patient safety or obtaining informed consent
Outcomes
Primary Outcomes
Not specified
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