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

Status: Active

Description

This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult Subjects 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 subjects with recurrent or metastatic colorectal cancer (CRC).

Eligibility Criteria

Inclusion Criteria

  • Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
  • Subjects must be at the recurrent/metastatic setting, with selected advanced solid tumors.
  • Subjects must have at least one lesion that is measurable by RECIST v1.1
  • Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.

Exclusion Criteria

  • 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.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Approved
Name Not Available
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Charlean Ketchens
Phone: 323-865-3035
Email: ketchens_c@med.usc.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Jennifer Robinson Diamond
Phone: 720-848-0650
Email: jennifer.diamond@ucdenver.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Nishi Kothari
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Jarushka Naidoo
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Contact: Stephen Hodi
Email: FHODI@PARTNERS.ORG
Dana-Farber Cancer Institute
Status: Active
Contact: Stephen Hodi
Email: FHODI@PARTNERS.ORG

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: In review
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Marcella West Aguilar
Phone: 214-648-1479
Email: marcella.aguilar@utsouthwestern.edu

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

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 subjects 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 subjects 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 subjects with CRC.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

Primary ID D419NC00001
Secondary IDs NCI-2016-00684
Clinicaltrials.gov ID NCT02671435