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An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

CheckMate 651: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 651)

Acronym: Checkmate651

Summary & Eligibility:

The purpose of this study is to test the effectiveness, safety, and tolerability of the combination of two investigational drugs called Nivolumab and Ipilimumab.

Nivolumab and Ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells.  Nivolumab (Opdivo ™) has been approved in the UK for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers.  Ipilimumab (Yervoy™) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma.

The effectiveness of Nivolumab and Ipilimumab in squamous cell carcinoma of the head and neck (SCCHN) will be determined by comparing progression free survival and overall survival of subjects who receive Nivolumab and Ipilimumab to those who receive Cetuximab plus Cisplatin or Carboplatin with Fluorouracil.  This chemotherapy regimen is considered a standard therapy for SCCHN.

Patients who qualify to participate in the study based on the screening and baseline results will be randomly assigned to receive one of the two study treatments below by intravenous infusion (through a vein). The two arms of treatment in the study are;

  • Arm A: Nivolumab+Ipilimumab or
  • Arm B: Cetuximab+Cisplatin/Carboplatin and 5- Fluorouracil

General Inclusion Criteria

  • Aged 18 years or above.
  • Confirmed head and neck squamous cell carcinoma (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx.
  • Have metastatic or recurrent disease
  • No prior treatment with systemic anti-cancer therapy for recurrent or metastatic SCCHN, except if given as adjuvant or neoadjuvant chemotherapy
  • Documentation of HPV p-16 status for SCCHN tumor of the oropharynx.

General Exclusion Criteria

  • Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland
  • Carcinomatous meningitis or a serious infection (e.g. Herpes zoster, chicken pox). An active, known or suspected autoimmune disease or use of live vaccines.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Prior treatment with cetuximab or EGFR inhibitors in any treatment setting. 
  • Subjects with previous malignancies
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection 
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Inadequte blood values

For full inclusion and inclusion criteria, please contact the InHANSE team.

Status: Open

Sponsor: Bristol-Myers Squibb

Study Coordinator:

Shiphali Shetty 
Clinical Site Manager

Study Schema:

Charity appeal

Find out more about our £1m Charity appeal for the AcceleraTED cancer Treatment programme.