An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from
any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and
larynx.

- Recurrent or metastatic disease that is not amenable to therapy with curative intent
(surgery or radiation therapy with or without chemotherapy)

- No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol
specified criteria are met

- ECOG Performance Status of 0-1

- Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of
unknown primary, squamous cell carcinoma that originated from the skin and salivary
gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)

- Participants with untreated CNS metastases are excluded

- Participants with carcinomatous meningitis

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

Other protocol defined inclusion/exclusion criteria could apply