Study in Subjects With Small Primary Choroidal Melanoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03052127 |
|
Recruitment Status :
Completed
First Posted : February 14, 2017
Last Update Posted : January 14, 2022
|
Sponsor:
Aura Biosciences
Information provided by (Responsible Party):
Aura Biosciences
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveal Melanoma Ocular Melanoma Choroidal Melanoma | Drug: Light-activated AU-011 Device: Laser Activation | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 27, 2017 |
| Actual Primary Completion Date : | January 26, 2021 |
| Actual Study Completion Date : | January 26, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Single Low Dose Light-activated AU-011
Low dose Light-activated AU-011 followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Single Medium Dose Light-activated AU-011
Medium dose Light-activated AU-011 followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Single High Dose Light-activated AU-011
High dose Light-activated AU-011 followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: 2 Repeat Medium Dose Light-activated AU-011
2 repeat medium doses of Light-activated AU-011 each followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: 3 Repeat Medium Dose Light-activated AU-011
3 repeat medium doses of Light-activated AU-011 followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Single High Dose Light-activated AU-011 x 2 lasers
High dose Light-activated AU-011 followed by two laser light applications
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: 3 Repeat High Dose Light-activated AU-011
3 repeat high doses of Light-activated AU-011 each followed by a single laser light application
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: 3 Repeat High Dose Light-activated AU-011 x 2 lasers
3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Expansion 3 Repeat High Dose Light-activated AU-011 x 2 lasers
Expansion of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications (up to 12 additional subjects)
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Observation until Documented Growth of Tumor
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
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: 2 Cycles of 3 Repeat High Dose Light-activated AU-011x2 lasers
2 cycles each of 3 repeat high doses of Light-activated AU-011 each followed by two laser light applications
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
|
Experimental: Exp: 2 Cycles 3 Repeat High Dose Light-activatedAU-011x2lasers
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
|
Drug: Light-activated AU-011
Study treatment Device: Laser Activation Study treatment
Other Name: PDT Laser |
Primary Outcome Measures :
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 [ Time Frame: Informed consent through 2 years ]Adverse events will be summarized by presenting the number and percentage of patients having any adverse event.
Secondary Outcome Measures :
- Immunogenicity [ Time Frame: Screening to various time points through Week 52 ]Anti-Drug Antibody analysis
- Tumor size (thickness) measured by ultrasonography [Efficacy] [ Time Frame: Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) ]Tumor size (thickness) measured by ultrasonography (millimeters)
- Tumor size (diameter) measured by fundus photography [Efficacy] [ Time Frame: Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) ]Tumor size (diameter) measured by fundus photography (millimeters)
- Best Corrected Visual Acuity measured by ETDRS Method [Efficacy] [ Time Frame: Change from baseline at 3 months following treatment and at each subsequent visit through study completion (2 years) ]Changes in ETDRS best corrected visual acuity (BCVA)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of choroidal melanoma
Exclusion Criteria:
- Have known contraindications or sensitivities to the study drug
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052127
Locations
| United States, Arizona | |
| Retina Associates SW, P.C. | |
| Tucson, Arizona, United States, 85710 | |
| United States, California | |
| UCLA Jules Stein Eye Institute | |
| Los Angeles, California, United States, 90095 | |
| Byers Eye Institute at Stanford University | |
| Palo Alto, California, United States, 94303 | |
| Retina Consultants of Sacramento | |
| Sacramento, California, United States, 95819 | |
| United States, Colorado | |
| Colorado Retina Associates | |
| Denver, Colorado, United States, 80210 | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| W. K. Kellogg Eye Center, University of Michigan | |
| Ann Arbor, Michigan, United States, 48105 | |
| Associated Retinal Consultants, PC | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Retina Center | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10027 | |
| United States, Pennsylvania | |
| Wills Eye Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Retina Consultants of Carolina, PA | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Retina Consultants of Houston | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Aura Biosciences
Investigators
| Study Director: | Abhijit Narvekar, MBBS | Aura Biosciences |
| Responsible Party: | Aura Biosciences |
| ClinicalTrials.gov Identifier: | NCT03052127 |
| Other Study ID Numbers: |
AU-011-101 |
| First Posted: | February 14, 2017 Key Record Dates |
| Last Update Posted: | January 14, 2022 |
| Last Verified: | January 2022 |
| 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 |
Keywords provided by Aura Biosciences:
|
Uveal melanoma Eye cancer Ocular melanoma Choroidal melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |