A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies

Summary

To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

Conditions

• Select Advanced Malignancies
• Kidney Cancer
• Clear Cell Renal Cell Carcinoma

Interventions

BIOLOGICAL

MEDI0680

Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase.

BIOLOGICAL

Durvalumab

Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.

BIOLOGICAL

Nivolumab

Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.

Sponsors & Collaborators

• MedImmune LLC

  lead INDUSTRY

Principal Investigators

• Laura Chow, MD · University of Washington

• Omid Hamid, MD · The Angeles Clinic

• Jhanelle Gray, MD · Moffitt Cancer Center

• Rachel Sanborn, MD · Providence Cancer Center

• Mohamad Salkeni, MD · Mary Babb Randolph Cancer Center

• Monika Joshi, MD · Penn State Hershey Cancer Institute

• Robert Alter, MD · John Theurer Cancer Center

• Raid Aljumaily, MD · Peggy Charles Stephenson Cancer Center

• Jason Chesney, MD · Brown Cancer Center

• Fernando Quevedo, MD · Mayo Clinic

• Martin Voss, MD · Memorial Sloan Kettering Cancer Center

• Johanna Bendell · SCRI Development Innovations, LLC

• Elizabeth Henry · Loyola Univ. Medical Center

• Lionel Lewis · Dartmouth-Hitchcock Medical Center

• Brian Rini · The Cleveland Clinic

• Peter Van Veldhuizen · Menorah Medical Center tour

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

2014-05-19

Primary Completion

2020-03-17

Completion

2020-03-17

Countries

• United States
• Australia
• Canada
• France
• Netherlands
• United Kingdom

Study Locations