Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer
Not yet recruiting. At Dana-Farber - Harvard Cancer Center. Boston, Massachusetts.
All 3 arms receive the 2 immuno drugs: A: two drugs without radiation; B: two drugs with radiation at a low dose; C: B: two drugs with radiation at a higher dose.
Lesion to be radiated has to be in liver.
Only for MSS
(Patients on the CRC arm need to have: "Microbiology Susceptibility Subcategory (MSS) tumor as documented by either:
Immunohistochemistry (IHC) testing that does not suggest loss of MLH-1, MSH-2, PMS2 or MSH6
Polymerase chain reaction (PCR) testing that does not suggest microsatellite instability (MSI))
durvalumab (MEDI4736): anti PD-L1, similar to atezolizumab.
tremelimumab: anti-CTLA-4, similar to ipilimumab.
More about the combination here: (May 2014) viewtopic.php?f=1&t=46727 and (Nov 2015) viewtopic.php?f=1&t=52938
In a nutshell
This phase 1/2 trial aims to study the safety and effectiveness of the treatment with different targeted therapy in patients with advanced lung or colorectal cancer. The main outcome to be measured is the response rate of the tumor to the treatment and the negative side effects. This trial is recruiting in California, Illinois and Texas, United States.
How will it work
Patients will receive increasing doses, by injection, of azacitidine over days 1 and 7, pembrolizumab over 30 minutes every 3 weeks on day 1 and epacadostat tablets twice daily. Treatment will repeat until disease progression or unacceptable side effects. Participants will be followed for up to 18 months.
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