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Clinical Trials/EUCTR2016-001645-64-BE
EUCTR2016-001645-64-BE
Active, not recruiting
Phase 1

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in Combination with Ipilimumab Placebo In Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) - CheckMate 714

Bristol-Myers Squibb International Corporation0 sites675 target enrollmentSeptember 6, 2016
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ConditionsRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)MedDRA version: 21.1Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOpdivo (100 mg/10 ml)YERVOY 5 mg/ml

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
675
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2016
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Confirmed squamous cell head and neck cancer
  • •Widespread (metastatic) disease, or returned after previous treatment (recurrent)
  • •Tumor sample must be available for analysis of PDL1 and HPV (oropharynx only)
  • •Performance status (ECOG 0\-1\)
  • •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 473
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 202

Exclusion Criteria

  • •Previous treatment of metastatic or recurrent disease
  • •Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
  • •Any non\-squamous subtype
  • •Active autoimmune disease
  • •Positive test for hepatitis B, C or HIV virus
  • •Previous treatment with checkpoint inhibitor drugs
  • •Active CNS metastases or carcinomatous meningitis

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Study of Nivolumab in Combination with Ipilimumab compare to nivolumab in combination with Ipilimumab-Placebo in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)MedDRA version: 20.0Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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Study of Nivolumab in Combination with Ipilimumab compare to nivolumab in combination with Ipilimumab-Placebo in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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