IRB #

STUDY00016230

Title

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Principal Investigator

Jeremy Cetnar

Study Purpose

The purpose of this study is to compare the effectiveness (how well the drug works), safety, and tolerability of the combination of two investigational drugs called nivolumab and ipilimumab.

Medical Condition(s)

Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Eligibility Criteria

Male or Female over the age of 18
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:
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

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

There is no fixed treatment duration for this study. Participants will receive the study drug in 28-day cycles. Participants may continue treatment with the study drug until any of the following occurs:

1) Participant's disease worsens.

2) Participant experiences unacceptable side effects.

3) Investigator stops treatment.

4) Participant voluntarily withdraw from the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Bristol-Myers Squibb Research and Development

Recruitment End

12/31/2030

Compensation Provided

Yes

Compensation

Subjects may or may not be able to receive reimbursement for travel related to the study