Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck



Status:Active, not recruiting
Healthy:No
Age Range:18 - 96
Updated:2/10/2019
Start Date:April 15, 2015
End Date:December 31, 2019

Use our guide to learn which trials are right for you!

A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The purpose of this study is to determine the efficacy and safety of investigational medical
products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab
combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of
the head and neck who have progressed during or after treatment with a platinum containing
regimen for recurrent/metastatic disease.

This is a randomized, open-label, multi-center, global, Phase II study to determine the
efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and
tremelimumab monotherapy in the treatment of patients with recurrent or metastatic
PD-L1-negative squamous cell carcinoma of the head and neck (SCCHN) who have progressed
during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic
disease, that must have contained a platinum agent.

Patients will be randomized in a stratified manner according to prognostic factors, including
human papillomavirus (HPV) status and smoking status to achieve a balance between treatments
for each of the factors. Patients will be randomized in a 1:1:2 fashion to receive MEDI4736
monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination.

All treatments will be administered beginning on Day 0 for 12 months or until confirmed
progression of disease; unless, in the Investigator's opinion, the patient continues to
receive benefit from the treatment), initiation of alternative cancer therapy, unacceptable
toxicity, withdrawal of consent, or another discontinuation criterion is met. Patients with
confirmed progression of disease who, in the Investigator's opinion, continue to receive
benefit from their assigned investigational product and who meet the criteria for treatment
in the setting of progression of disease may continue to receive their assigned
investigational product treatment for a maximum of 12 months after consultation with the
Sponsor and at the Investigator's discretion. The monotherapy arms (tremelimumab and
MEDI4736) should be discontinued if there is confirmed progression of disease following a
previous response in target lesions (complete response or partial response).

Tumor assessments will be performed using computed tomography or magnetic resonance imaging.
Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (q8w)
for the first 48 weeks (relative to the date of the first infusion) then q12w in patients who
have disease control after 12 months until confirmed objective disease progression.

Following completion or discontinuation of treatment, patients will enter a follow-up period.

Inclusion Criteria:

- Age ≥18 years;

- Written informed consent obtained from the patient/legal representative;

- Histologically confirmed recurrent or metastatic SCCHN; tumor progression or
recurrence during or after treatment with only 1 systemic palliative regimen for
recurrent or metastatic disease that must have contained a platinum agent; Patients
who have only received chemo-radiation with curative intent for treatment of their
locally advanced disease or recurrent disease are not eligible. Patients who received
concurrent chemo-radiation as part of treatment of their recurrent disease are also
not eligible.

- Written consent to provide newly acquired tumor tissue (preferred) or archival tissue
for the purpose of establishing PD-L1 status.

- Confirmed PD-L1-negative SCCHN by Ventana SP263;

- WHO/ECOG performance status of 0 or 1;

- At least 1 measurable lesion at baseline;

- No prior exposure to immune-mediated therapy;

- Adequate organ and marrow function; Evidence of post-menopausal status or negative
urinary or serum pregnancy test.

Exclusion Criteria:

- Histologically confirmed squamous cell carcinoma of any other primary anatomic
location in the head and neck;

- Received more than 1 regimen for recurrent or metastatic disease

- Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy
for cancer treatment;

- Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;

- Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy,
targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose
of study treatment;

- Major surgical procedure within 28 days prior to the first dose of Investigational
Product;

- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criterion;

- Current or prior use of immunosuppressive medication within 14 days before the first
dose of their assigned Investigational Product;

- History of allogeneic organ transplantation;

- Active or prior documented autoimmune or inflammatory disorders;

- Uncontrolled intercurrent illness;

- another primary malignancy

- Patients with history of brain metastases, spinal cord compression, or a history of
leptomeningeal carcinomatosis;

- History of active primary immunodeficiency;

- Known history of previous tuberculosis;

- Active infection including hepatitis B, hepatitis C or human immunodeficiency virus
(HIV);

- Receipt of live, attenuated vaccine within 30 days prior to the first dose of
Investigational Product;

- Pregnant or breast-feeding female patients;

- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3
electrocardiograms (ECGs) using Fridericia's Correction

- Known allergy or hypersensitivity to Investigational Product.

- Any condition that, in the opinion of the Investigator, would interfere with
evaluation of the IP or interpretation of patient safety or study results
We found this trial at
44
sites
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Adelaide,
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Downey, CA
Click here to add this to my saved trials
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Southfield, MI
Click here to add this to my saved trials
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Yuma, AZ
Click here to add this to my saved trials