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

Phase 1

• Conditions: MedDRA version: 19.0Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001645-64-NL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-20
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 451

Inclusion Criteria

Confirmed squamous cell head and neck cancer
Widespread (metastatic) disease, or returned after previous treatment (recurrent)
No previous treatment for metastatic or recurrent disease
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 316
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified