NCT02671435

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

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Monalizumab	Participants will receive IV infusion of monalizumab as stated in arm description.
DRUG	Durvalumab	Participants will receive IV infusion of durvalumab as stated in arm description.
DRUG	Cetuximab	Participants will receive IV infusion of cetuximab as stated in arm description.
DRUG	mFOLFOX6	Participants will receive IV infusion of mFOLFOX as stated in arm description.
DRUG	Bevacizumab	Participants will receive IV infusion of bevacizumab as stated in arm description.

Timeline

• Start date: 2016-02-22
• Primary completion: 2021-10-26
• Completion: 2025-09-01
• First posted: 2016-02-02
• Last updated: 2025-07-22
• Results posted: 2023-03-09

Locations

49 sites across 11 countries: United States, Australia, Belgium, Canada, France, Hungary, Italy, New Zealand, South Korea, Spain, United Kingdom