A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers (NCT02643303) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
United States58 participantsStarted 2016-12-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies:
✓. Subjects with measurable disease, must have at least 2 lesions (1 measurable lesion and 1 biopsy/injectable lesion, which does not need to be measurable).
✓. Any number of prior systemic therapies.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Laboratory parameters for vital functions should be in the normal range or not clinically significant.
Exclusion criteria
✕. Prior treatment with combination CTLA-4 and PD-1/PD-L1 blockade, with the exception of subjects with melanoma.
✕. Participants may not have been treated intratumorally with poly-ICLC.
✕. 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 active 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.
✕. Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease or clinically uncontrolled hypertension.
✕. History of pneumonitis or interstitial lung disease or any unresolved immune-related adverse events following prior biological therapy.
What they're measuring
1
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Timeframe: up to 15 months
2
Number of Subjects With Best Overall Tumor Response by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
✕. 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 cancers).
✕. Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who require drainage gastrostomy tube and/or parenteral hydration or nutrition.
✕. Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C positivity. Antibody to Hepatitis B or C without evidence of active infection may be allowed.