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

Part of paid clinical trials in Los Angeles, California.

Sponsor
MedImmune LLC
Study ID
NCT02118337
Phase
PHASE1/PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI0680 — BIOLOGICAL
    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.
  • Durvalumab — BIOLOGICAL
    Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.
  • Nivolumab — BIOLOGICAL
    Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.

Study Details

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

Key Dates

Start date
May 19, 2014
Status verified
May 2021
Primary completion
Mar 17, 2020
Completion
Mar 17, 2020

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg
    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.
  • Experimental: MEDI0680 0.1 mg/kg + Durvalumab 10 mg
    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.
  • Experimental: MEDI0680 0.5 mg/kg + Durvalumab 10 mg
    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.
  • Experimental: MEDI0680 2.5 mg/kg + Durvalumab 10 mg
    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.
  • Experimental: MEDI0680 10 mg/kg + Durvalumab 10 mg
    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.
  • Experimental: MEDI0680 20 mg/kg + Durvalumab 10 mg
    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.
  • Experimental: MEDI0680 20 mg/kg
    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.
  • Experimental: MEDI0680 20 mg/kg + Durvalumab 750 mg
    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.
  • Active Comparator: Nivolumab 240 mg
    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.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90025-
Research SiteTampaFlorida33612-
Research SiteOverland ParkKansas66209-
Research SiteLouisvilleKentucky40202-
Research SiteRochesterMinnesota55905-
Research SiteHackensackNew Jersey07601-
Research SiteNew YorkNew York10065-
Research SiteClevelandOhio44195-
Research SiteOklahoma CityOklahoma73104-
Research SitePortlandOregon97213-
Research SiteHersheyPennsylvania17033-0850-
Research SiteNashvilleTennessee37203-
Research SiteSeattleWashington98109-

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