NCT02118337

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

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 Subjects With Select Advanced Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-19
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2014-04-21
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

27 sites across 6 countries: United States, Australia, Canada, France, Netherlands, United Kingdom