An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
Trial Status: closed to accrual
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion
study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK),
pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with
monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the
combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy
with or without biological agent and monalizumab (IPH2201) with biological agent
administered to participants with recurrent or metastatic colorectal cancer (CRC).
Inclusion Criteria
Participants must have histologic documentation of advanced recurrent or metastatic cancer.
Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
Participants must have at least one lesion that is measurable by RECIST v1.1
Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.
Exclusion Criteria
Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
Additional locations may be listed on ClinicalTrials.gov for NCT02671435.
