For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Participants must have histologic documentation of advanced recurrent or metastatic cancer.
  2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
  3. Participants must have at least one lesion that is measurable by RECIST v1.1
  4. 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

Exclusion Criteria


  1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
  2. 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
  3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
  4. 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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Advanced Solid Tumors

Age (in years)

18 - 99

Phase

Phase 1/Phase 2

Participants needed

383

Est. Completion Date

Sep 2, 2024

Treatment type

Interventional


Sponsor

MedImmune LLC

ClinicalTrials.gov identifier

NCT02671435

Study number

D419NC00001

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