A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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).

Key facts

Study ID

NCT02671435

Run by

MedImmune LLC

People needed

383

Starts

2016-02-22

Expected to finish

2027-07-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Duarte, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Tampa, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — New Brunswick, New Jersey, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — New York, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Providence, Rhode Island, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Blacktown, Australia
• Research Site — Clayton, Australia
• Research Site — Waratah, Australia

Full record on ClinicalTrials.gov

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