NCT03089645

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Typical duration for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

January 19, 2017

Last Update Submit

July 24, 2020

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (7)

  • Number of participants with Adverse Events (AEs) as a measure of safety

    Safety Endpoint

    From the time of consent through 120 days after last treatment

  • Number of participants with Serious Adverse Events (SAEs) as a measure of safety

    Safety Endpoint

    From the time of consent through 120 days after last treatment

  • Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety

    Safety Endpoint

    From the time of first dose through 28 days thereafter

  • The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose

    Safety Endpoint

    From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

  • Discontinuation of investigational products due to toxicity

    Safety Endpoint

    From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

  • Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.

    Safety Endpoint

    From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

  • Antitumor activity endpoints OR, based on RECIST v1.1

    Safety Endpoint

    Part 3

Secondary Outcomes (14)

  • Serum MEDI5083 concentration levels

    From the time of first dose through 57 days after first treatment

  • Reduction in peripheral blood CD19+ B cells

    From the time of first dose through 57 days after first treatment

  • Incidence of anti-drug antibody (ADA) responses to MEDI5083

    From the time of first dose through 2 years after last treatment

  • Objective Response Rate (ORR)

    From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

  • Progression Free Survival (PFS) at 6 months (PFS-6)

    From the time of first dose until 6 months after the last subject is dosed

  • +9 more secondary outcomes

Study Arms (3)

Part 1

EXPERIMENTAL

MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors

Biological: MEDI5083 monotherapy

Part 2

EXPERIMENTAL

Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.

Biological: MEID5083 with Durvalumab or Tremelimumab

Part 3

EXPERIMENTAL

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC

Biological: Medi5083 with Durvalumab and Docetaxel

Interventions

MEDI5083 monotherapyBIOLOGICAL

Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

Part 1
MEID5083 with Durvalumab or TremelimumabBIOLOGICAL

Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab

Part 2
Medi5083 with Durvalumab and DocetaxelBIOLOGICAL

Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel

Part 3

Eligibility Criteria

Age18 Years - 101 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years at the time of screening or age of consent according to local law
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically confirmed metastatic or recurrent tumor types
  • Subjects who have received prior immunotherapy may be eligible
  • Subjects must have at least one measurable lesion
  • Consent to provide archival tumor tissue and pre/on-treatment biopsies
  • Adequate organ and marrow function
  • Consent to use one highly effective method of contraception

You may not qualify if:

  • Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
  • Concurrent enrollment in another clinical study
  • Active/prior autoimmune of inflammatory disorders
  • History of immunodeficiency, solid organ transplant, or tuberculosis
  • Known allergy/hypersensitivity to drug or components
  • Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Hackensack, New Jersey, 07601-2191, United States

Location

Research Site

Providence, Rhode Island, 02903, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Salt Lake City, Utah, 84112, United States

Location

Research Site

Clayton, 3168, Australia

Location

Research Site

Melbourne, 3000, Australia

Location

Research Site

Melbourne, 3004, Australia

Location

Research Site

Randwick, 2031, Australia

Location

MeSH Terms

Interventions

durvalumabtremelimumabDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • MedImmune LLC

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

March 24, 2017

Study Start

March 21, 2017

Primary Completion

June 23, 2020

Study Completion

June 23, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

US(4)AU(4)