Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | September 22, 2016 |
| End Date: | January 30, 2024 |
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)
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to
evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
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 (Programmed death-ligand 1) and
HPV [Human Papilloma Virus (oropharynx only)]
- Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)
Exclusion Criteria:
- Previous treatment for 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 (Human Immunodeficiency Virus) virus
- Previous treatment with checkpoint inhibitor drugs
- Active CNS metastases or carcinomatous meningitis
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
29
sites
450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6817
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-834-8528
University of Chicago One of the world's premier academic and research institutions, the University of...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-418-9652
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-6209
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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201 South Alvarado Street
Los Angeles, California 90017
Los Angeles, California 90017
Phone: 310-989-7757
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University of Louisville The University of Louisville is a state supported research university located in...
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333 Cedar St
New Haven, Connecticut 06504
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-494-9097
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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2603 Kentucky Avenue
Paducah, Kentucky 42003
Paducah, Kentucky 42003
Phone: 270-444-3930
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1115 Avenida de Mayo
Pergamino, Buenos Aires
Pergamino, Buenos Aires
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