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Study in Subjects With Small Primary Choroidal Melanoma

Primary Purpose

Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Light-activated AU-011
Laser Activation
Sponsored by
Aura Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveal Melanoma focused on measuring Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of choroidal melanoma

Exclusion Criteria:

  • Have known contraindications or sensitivities to the study drug

Sites / Locations

  • Retina Associates SW, P.C.
  • UCLA Jules Stein Eye Institute
  • Byers Eye Institute at Stanford University
  • Retina Consultants of Sacramento
  • Colorado Retina Associates
  • Massachusetts Eye and Ear Infirmary
  • W. K. Kellogg Eye Center, University of Michigan
  • Associated Retinal Consultants, PC
  • Retina Center
  • Columbia University Medical Center
  • Wills Eye Hospital
  • Retina Consultants of Carolina, PA
  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Single Low Dose Light-activated AU-011

Single Medium Dose Light-activated AU-011

Single High Dose Light-activated AU-011

2 Repeat Medium Dose Light-activated AU-011

3 Repeat Medium Dose Light-activated AU-011

Single High Dose Light-activated AU-011 x 2 lasers

3 Repeat High Dose Light-activated AU-011

3 Repeat High Dose Light-activated AU-011 x 2 lasers

Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers

Observation until Documented Growth of Tumor

2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers

Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers

Arm Description

Low dose Light-activated AU-011 followed by a single laser light application

Medium dose Light-activated AU-011 followed by a single laser light application

High dose Light-activated AU-011 followed by a single laser light application

2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application

3 repeat medium doses of Light-activated AU-011 followed by a single laser light application

High dose Light-activated AU-011 followed by two laser light applications

3 repeat high doses of Light-activated AU-011 each followed by a single laser light application

3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)

Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications

2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Adverse events will be summarized by presenting the number and percentage of patients having any adverse event.

Secondary Outcome Measures

Immunogenicity
Anti-Drug Antibody analysis
Tumor size (thickness) measured by ultrasonography [Efficacy]
Tumor size (thickness) measured by ultrasonography (millimeters)
Tumor size (diameter) measured by fundus photography [Efficacy]
Tumor size (diameter) measured by fundus photography (millimeters)
Best Corrected Visual Acuity measured by ETDRS Method [Efficacy]
Changes in ETDRS best corrected visual acuity (BCVA)

Full Information

First Posted
February 6, 2017
Last Updated
January 12, 2022
Sponsor
Aura Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03052127
Brief Title
Study in Subjects With Small Primary Choroidal Melanoma
Official Title
A Phase 1B/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-activated AU-011 for the Treatment of Subjects With Small Primary Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
January 26, 2021 (Actual)
Study Completion Date
January 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aura Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
Detailed Description
This is a phase 1B/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of Light-activated AU-011 for the treatment of subjects with small primary choroidal melanoma. Throughout the study, subjects will be monitored through medical and ophthalmic assessments. Subjects will be followed for a total of 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma
Keywords
Uveal melanoma, Eye cancer, Ocular melanoma, Choroidal melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Low Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
Low dose Light-activated AU-011 followed by a single laser light application
Arm Title
Single Medium Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
Medium dose Light-activated AU-011 followed by a single laser light application
Arm Title
Single High Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
High dose Light-activated AU-011 followed by a single laser light application
Arm Title
2 Repeat Medium Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
Arm Title
3 Repeat Medium Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
Arm Title
Single High Dose Light-activated AU-011 x 2 lasers
Arm Type
Experimental
Arm Description
High dose Light-activated AU-011 followed by two laser light applications
Arm Title
3 Repeat High Dose Light-activated AU-011
Arm Type
Experimental
Arm Description
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
Arm Title
3 Repeat High Dose Light-activated AU-011 x 2 lasers
Arm Type
Experimental
Arm Description
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Arm Title
Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Arm Type
Experimental
Arm Description
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
Arm Title
Observation until Documented Growth of Tumor
Arm Type
Experimental
Arm Description
Observation until documented growth of tumor and then treatment with 2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Arm Title
2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
Arm Type
Experimental
Arm Description
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
Arm Title
Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
Arm Type
Experimental
Arm Description
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications in subjects with evidence of documented tumor growth prior to study entry
Intervention Type
Drug
Intervention Name(s)
Light-activated AU-011
Intervention Description
Study treatment
Intervention Type
Device
Intervention Name(s)
Laser Activation
Other Intervention Name(s)
PDT Laser
Intervention Description
Study treatment
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011
Description
Adverse events will be summarized by presenting the number and percentage of patients having any adverse event.
Time Frame
Informed consent through 2 years
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Anti-Drug Antibody analysis
Time Frame
Screening to various time points through Week 52
Title
Tumor size (thickness) measured by ultrasonography [Efficacy]
Description
Tumor size (thickness) measured by ultrasonography (millimeters)
Time Frame
Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)
Title
Tumor size (diameter) measured by fundus photography [Efficacy]
Description
Tumor size (diameter) measured by fundus photography (millimeters)
Time Frame
Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)
Title
Best Corrected Visual Acuity measured by ETDRS Method [Efficacy]
Description
Changes in ETDRS best corrected visual acuity (BCVA)
Time Frame
Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of choroidal melanoma Exclusion Criteria: Have known contraindications or sensitivities to the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhijit Narvekar, MBBS
Organizational Affiliation
Aura Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Retina Associates SW, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
UCLA Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Byers Eye Institute at Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Retina Consultants of Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Colorado Retina Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
W. K. Kellogg Eye Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Associated Retinal Consultants, PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Retina Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Retina Consultants of Carolina, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study in Subjects With Small Primary Choroidal Melanoma

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