This is an open-label, multicenter Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator polyICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||December 28, 2016||Phase 1/Phase 2||Interventional|
Primary Outcome 1 - Measure: Progression-Free Survival (PFS) at 24 weeks
Primary Outcome 1 - Time Frame: up to 24 weeks
1. Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable
cancers of the following histologies:
- Non-viral-associated head and neck squamous cell carcinoma (HNSCC) or
HPV-associated HNSCC after failure of prior therapy
- Locally recurrent or metastatic breast cancer
- Merkel Cell Carcinoma (MCC)
- Cutaneous T cell Lymphoma (CTCL)
- Melanoma after failure of available therapies
- GU cancers with accessible metastases (e.g., bladder, renal)
- Any solid tumors with masses that are accessible
2. Subjects with measurable disease, must have at least 2 lesions (1 measurable lesion
and 1 biopsy/injectable lesion, which will not need to be measurable).
3. Any number of prior systemic therapies.
4. ECOG performance status 0-1.
5. Laboratory parameters for vital functions should be in the normal range or not
1. Prior treatment with combination CTLA-4 and PD-1/PD-L1 blockade, with the exception of
subjects with melanoma.
2. Participants may not have been treated intratumorally with polyICLC.
3. Subjects with history or evidence upon physical examination of central nervous system
(CNS) disease, including primary brain tumor, seizures not controlled with standard
medical therapy, any brain metastases, or, within 6 months of the first date of
treatment on this study, history of cerebrovascular accident (CVA, stroke), transient
ischemic attack (TIA) or subarachnoid hemorrhage.
4. Active, suspected or prior documented autoimmune disease, clinically significant
cardiovascular disease or clinically uncontrolled hypertension.
5. History of pneumonitis or interstitial lung disease or any unresolved immune-related
adverse events following prior biological therapy.
6. Other malignancy within 2 years prior to entry into the study, except for those
treated with surgical therapy only (e.g., localized low-grade cervical or prostate
7. Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who
require drainage gastrostomy tube and/or parenteral hydration or nutrition.
8. Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C positivity. Antibody to
Hepatitis B or C without evidence of active infection may be allowed.
9. History of severe allergic reactions to any unknown allergens or any components of the
10. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding
11. History of allogeneic organ transplant.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Craig L Slingluff, Jr., MD
Role: Study Chair
Affiliation: University of Virginia
Name: Kristen Aufiero Ramirez
Atlanta, Georgia 30322
Lebanon, New Hampshire 03756
Buffalo, New York 14263
New York, New York 10029
Cleveland, Ohio 44195
Toledo, Ohio 43614
Charlottesville, Virginia 22908
Emily H. Allred, PhD, CCRC