Colon Cancer Clinical Trial
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult Subjects 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 subjects with recurrent or metastatic colorectal cancer (CRC).
The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult participants with select advanced solid tumor malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult participants with select advanced solid tumor malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult participants with CRC.
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.
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.
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There are 49 Locations for this study
Birmingham Alabama, 35233, United States
Scottsdale Arizona, 85258, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90089, United States
Sacramento California, 95817, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10461, United States
New Hyde Park New York, 11042, United States
New York New York, 10065, United States
Providence Rhode Island, 02903, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75235, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Blacktown , 2148, Australia
Clayton , 3168, Australia
Waratah , 2298, Australia
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M5G 1, Canada
Marseille CEDEX 5 , 13385, France
Nantes CEDEX 1 , 44093, France
Debrecen , 4032, Hungary
Milano , 20132, Italy
Milano , 20141, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Grafton , 1023, New Zealand
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Málaga , 29010, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
London , SW2 6, United Kingdom
Sutton , SM2 5, United Kingdom
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