Phase 3
N=361
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT02105636 ↗Enrolled (actual)
361
Serious AEs
72.6%
Results posted
Jan 2017
Primary outcome: Primary: Overall Survival (OS) — 7.49; 5.06 Months — p=0.0101
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Cetuximab (Drug); Methotrexate (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
7.49; 5.06 | 0.0101 sig |
| SECONDARY Investigator-Assessed Progression-Free Survival (PFS) |
2.04; 2.33 | — |
| SECONDARY Investigator-Assessed Objective Response Rate (ORR) |
13.3; 5.8 | — |
Summary
The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
- Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
Exclusion Criteria
- Active brain metastases or leptomeningeal metastases are not allowed
- Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
- Subjects with active, known or suspected autoimmune disease
Data sourced from ClinicalTrials.gov (NCT02105636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.