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

MedImmune

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Cancer; Clear Cell Renal Cell Carcinoma; Select Advanced Malignancies

Treatments: Biological: Nivolumab; Biological: MEDI0680; Biological: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02118337

D6020C00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 9 patient groups

MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 0.1 mg/kg + Durvalumab 10 mg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 0.5 mg/kg + Durvalumab 10 mg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 2.5 mg/kg + Durvalumab 10 mg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 10 mg/kg + Durvalumab 10 mg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 20 mg/kg + Durvalumab 10 mg

Experimental group

Description:

Participants in dose-escalation phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

MEDI0680 20 mg/kg

Experimental group

Description:

Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.

Treatment:

Biological: MEDI0680

MEDI0680 20 mg/kg + Durvalumab 750 mg

Experimental group

Description:

Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.

Treatment:

Biological: Durvalumab

Biological: MEDI0680

Nivolumab 240 mg

Active Comparator group

Description:

Participants in dose-expansion phase will receive IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.

Treatment:

Biological: Nivolumab