Study on Durvalumab and Monalizumab for Treating Advanced Solid Tumors

Sponsor: MedImmune LLC

Sponsor score: 0

ClinicalTrials ID:NCT02671435

Provider View

This clinical trial is testing the safety and effectiveness of combining two drugs, Durvalumab and Monalizumab, in adults with advanced solid tumors, including colorectal cancer. The study aims to find the best dose and understand how the drugs work together.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the combination of two drugs, Durvalumab and Monalizumab, is for treating adults with advanced solid tumors. The study will also explore how these drugs work when used with standard cancer treatments, with or without additional biological agents, particularly in patients with recurrent or metastatic colorectal cancer.

Description

This study is divided into three parts:

  1. Dose Escalation (Part 1): Researchers will test increasing doses of Durvalumab combined with Monalizumab in adults with certain advanced solid tumors to find a safe and effective dose.

  2. Dose Expansion (Part 2): The dose identified in Part 1 will be further tested in more adults with advanced solid tumors to confirm its safety and effectiveness.

  3. Dose Exploration (Part 3): This part will explore different doses of Durvalumab and Monalizumab combined with standard cancer treatments, with or without additional biological agents, in adults with colorectal cancer. Participants in this part can be new to treatment but should not have had more than two previous treatments for their recurrent or metastatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced recurrent or metastatic cancer.
  • Must be in the recurrent/metastatic stage with selected advanced solid tumors.
  • Must have at least one tumor that can be measured by standard criteria.
  • For Part 3, colorectal cancer participants can be new to treatment but should not have had more than two previous treatments for their recurrent/metastatic cancer.

Exclusion Criteria

  • Cannot have had previous treatment with immunotherapy agents, although prior treatment with antitumor vaccines may be allowed after discussion.
  • Cannot have participated in studies involving Durvalumab alone or in combination if the study is still analyzing its main results.
  • Cannot have received any cancer treatment within four weeks before starting the study treatment.
  • Cannot be receiving any other cancer treatments, although hormones for non-cancer conditions are allowed.

Locations

FACILITYZIPCITYSTATE
Research Site35233BirminghamAlabama
Research Site85258ScottsdaleArizona
Research Site91010DuarteCalifornia
Research Site92093La JollaCalifornia
Research Site90089Los AngelesCalifornia
Research Site95817SacramentoCalifornia
Research Site90404Santa MonicaCalifornia
Research Site80045AuroraColorado
Research Site33612TampaFlorida
Research Site60611ChicagoIllinois

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