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Clinical Trials/EUCTR2014-003698-41-RO
EUCTR2014-003698-41-RO
Active, not recruiting
Not Applicable

A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.0 sites750 target enrollmentMarch 12, 2015
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DrugsCarboplatin 10 mg/ml Intravenous InfusionFluorouracil-GRYErbitux 5mg/mlCisplatin 1 mg/ml concentrate for solution for infusionCisplatin 1 mg/ml Sterile Concentrate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.
Enrollment
750
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 12, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.

Eligibility Criteria

Inclusion Criteria

  • •Have histologically or cytologically\-confirmed R/M HNSCC that is considered incurable by local therapies.
  • •Have measurable disease based on RECIST 1\.1 as determined by the site.
  • •Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • •Have results from local testing of HPV positivity for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cut off point.
  • •Have provided tissue for PD\-L1 biomarker analysis from a core or excisional biopsy.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 600
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Has disease that is suitable for local therapy administered with curative intent.
  • •Has progressive disease within six months of completion of curatively intended treatment for locoregionally advanced HNSCC.
  • •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.
  • •Has a known history of prior malignancy with recurrence in the last 5 years.
  • •Active autoimmune disease that has required systemic treatment in past 2 years.
  • •Has evidence of active, non\-infectious pneumonitis.
  • •Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent or if the patient has previously participated in Merck MK\-3475 clinical trials.
  • •Has an active infection requiring systemic therapy.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.Therapeutic area: Diseases [C] - Cancer [C04]
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Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.MedDRA version: 21.1Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem 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)MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.
EUCTR2014-003698-41-GRMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.750
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Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-003698-41-FIMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.750
Active, not recruiting
Phase 1
Pembrolizumab as First Line Treatment in Subjects with Recurrent/Metastatic HNSCC.Recurrent/metastatic head and neck squamous cell carcinoma.MedDRA version: 21.1Level: PTClassification code 10071540Term: Head and neck cancer metastaticSystem 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)MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-003698-41-ATMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc.825