A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
NCT02643303 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2022-12-02
Summary
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 poly-ICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Breast Cancer
- Sarcoma
- Merkel Cell Carcinoma
- Cutaneous T-Cell Lymphoma
- Melanoma
- Renal Cancer
- Bladder Cancer
- Prostate Cancer
- Testicular Cancer
- Solid Tumor
Interventions
- DRUG
- DRUG
-
Tremelimumab
- DRUG
-
Poly-ICLC
Sponsors & Collaborators
-
MedImmune LLC
collaborator INDUSTRY -
Cancer Research Institute, New York City
collaborator OTHER -
Ludwig Institute for Cancer Research
lead OTHER
Principal Investigators
-
Craig L Slingluff, Jr., MD · University of Virginia
-
Nina Bhardwaj, MD, PhD · Tisch Cancer Institute Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-28
- Primary Completion
- 2022-02-23
- Completion
- 2022-02-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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