drugset / Trial / NCT02643303
A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers
Phase 1/2
Completed
58 enrolled
Ludwig Institute for Cancer Research
Cancer Research Institute, New York City · collabMedImmune LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-12-28
- Primary completion
- 2022-02-23
- Completion
- 2022-02-23
Publications
- Background Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background Bohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Hiltonol | Other / unclassified | 1 mg | Intramuscular |
| Subject | Tremelimumab | Monoclonal antibody | 10 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |