Condition or disease | Intervention/treatment | Phase |
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Cutaneous Melanoma | Drug: Atezolizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neoadjuvant Atezolizumab in Patients With Non-Metastatic Resectable High-Risk Cutaneous Melanoma |
Estimated Study Start Date : | September 2020 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
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Experimental: Atezolizumab
Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.
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Drug: Atezolizumab
Anti-PD-L1 monoclonal antibody
Other Name: Tecentriq
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Houston Methodist Cancer Center | 713-441-0629 | ccresearch@houstonmethodist.org | |
Contact: Ashley Holder, M.D. | 713-441-0629 | ccresearch@houstonmethodist.org |
Principal Investigator: | Ashley Holder, M.D. | Houston Methodist Cancer Center |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 12, 2019 | ||||||||
First Posted Date ICMJE | July 16, 2019 | ||||||||
Last Update Posted Date | May 7, 2020 | ||||||||
Estimated Study Start Date ICMJE | September 2020 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Neoadjuvant Atezolizumab in Cutaneous Melanoma | ||||||||
Official Title ICMJE | Neoadjuvant Atezolizumab in Patients With Non-Metastatic Resectable High-Risk Cutaneous Melanoma | ||||||||
Brief Summary | The purpose of this research study is to see whether using atezolizumab before surgery is safe and does not cause side effects that delay surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk). | ||||||||
Detailed Description | The purpose of this study is to test the safety of using atezolizumab before surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk). Cutaneous melanoma in its earliest stages before it has spread to other areas of the body can usually be cured with surgery alone. Unfortunately, some cutaneous melanomas have a greater likelihood of coming back after surgery. Your immune system is normally your body's first defense against threats like cancer. But sometimes cancer cells produce signals that allow them to hide from attack by the immune system. One such signal is called programmed cell death-ligand 1 (PD-L1). Atezolizumab is a drug that blocks PD-L1. By blocking PD-L1, atezolizumab may boost your immune system to keep your cutaneous melanoma from coming back after surgery. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cutaneous Melanoma | ||||||||
Intervention ICMJE | Drug: Atezolizumab
Anti-PD-L1 monoclonal antibody
Other Name: Tecentriq
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Study Arms ICMJE | Experimental: Atezolizumab
Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.
Intervention: Drug: Atezolizumab
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2025 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04020809 | ||||||||
Other Study ID Numbers ICMJE | ML41440 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Nestor Esnaola, The Methodist Hospital System | ||||||||
Study Sponsor ICMJE | The Methodist Hospital System | ||||||||
Collaborators ICMJE | Genentech, Inc. | ||||||||
Investigators ICMJE |
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PRS Account | The Methodist Hospital System | ||||||||
Verification Date | May 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |