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

NCT02671435 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2025-07-22

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2021-10-26
Completion
2025-09-01

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Hungary
  • Italy
  • New Zealand
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671435 on ClinicalTrials.gov