- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03906526
Recruitment Status Recruiting
First Posted April 8, 2019
Last update posted September 1, 2020
This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.
|Experimental: Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
|Experimental: Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
|Experimental: Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
|Experimental: Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of
the oral cavity, pharynx, or larynx
- Macroscopic complete resection of the primary tumor must be planned and subjects
should have no medical contraindication to surgery.
- Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
- Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as
assessed by laboratory tests.
- Subject has any significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study
- Subject has unresectable or inoperable tumors
- Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or
unknown primary tumors
- Subject has evidence of distant metastasis
- Subject is a pregnant or nursing female.
- Subject has active or uncontrolled infection including known HIV infection or known
chronic hepatitis B or C.
- Subject has active autoimmune disease.
- Subject has clinically significant ophthalmologic disease.
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 email@example.com
United States, Alabama
University of Alabama at Birmingham
United States, California
University of California Los Angeles
United States, Iowa
University of Iowa Hospitals and Clinics
United States, Kansas
University of Kansas
United States, Massachusetts
United States, Missouri
United States, North Carolina
University of North Carolina
United States, Ohio
University of Cincinnati
United States, Ohio
The Ohio State University Comprehensive Cancer Center
United States, Pennsylvania
University of Pittsburgh Medical Center Hillman Cancer Center
United States, South Dakota
Sanford Cancer Center
Study Director: Amar Patel, MD Celgene Corporation