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:Active, not recruiting
Conditions:Cancer, Cancer, Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/23/2019
Start Date:May 19, 2014
End Date:July 15, 2019

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

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 subjects with selected advanced
malignancies.

Inclusion Criteria:

- Must be 18 years or older

- Eastern Cooperative Oncology Group performance status of 0-1

- Adequate organ function

- At least 1 prior line of therapy

Exclusion Criteria:

- Concurrent enrollment in another clinical study, unless in follow-up period or it is
an observational study

- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
treatment

- Prior treatment with immunotherapy
We found this trial at
14
sites
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Cleveland, OH
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