Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: CETUXIMAB
- biological: Monalizumab
- biological: Anti-PD(L)1
Eligibility
Main Inclusion Criteria:
1. Age ≥ 18 years
2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma
of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis,
glottis, subglottis) or oral cavity.
3. Recurrent or metastatic disease, documented by imaging (CT scan, MRI, X-ray) and/or
physical examination with measurable disease as per Response Evaluation Criteria in
Solid Tumors [RECIST] 1.1
For phase II cohorts:
- Cohort #1: Patients who received a maximum of two prior systemic regimens for
recurrent and/or metastatic disease and not amenable to further therapy with curative
intent
- Cohort #2: Patients with R/M SCCHN not amenable to therapy of curative intent, who
have received a maximum of two prior systemic regimens in the R/M setting and who have
received prior PD-(L)1 blockers
- Cohort #3: Patients with R/M SCCHN who have not received prior systemic regimens in
the R/M setting and who have not received prior PD-(L)1 inhibitors
Main Exclusion Criteria:
1. For phase II cohort #1 and cohort #2: Patients who received more than 2 prior systemic
regimens for recurrent and/or metastatic disease (no restriction in the phase Ib part
of the trial).
2. For phase II cohort #1 and cohort #2: Patients who received cetuximab or another
inhibitor of epidermal growth factor receptor are excluded from the phase II of the
trial, except if cetuximab was given as part of a primary treatment approach, with no
progressive disease for at least 4 months following the end of prior cetuximab
treatment.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Jun
650-721-4079
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.