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

Trial Status: Active

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).

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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Kim Kelly
Phone: 310-206-8309
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Sandip Pravin Patel
Phone: 858-822-5354

Colorado

Aurora
University of Colorado Hospital
Status: ACTIVE
Contact: Jennifer Robinson Diamond
Phone: 720-848-0650

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Nishi Kothari
Phone: 800-456-7121

Illinois

Chicago
Northwestern University
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Jarushka Naidoo
Phone: 410-955-8804

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Stephen Hodi
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Stephen Hodi

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: COMPLETED

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

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 Phase I/II

Trial Type Treatment

Lead Organization
MedImmune Inc

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