A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT04356729 |
Recruitment Status :
Recruiting
First Posted : April 22, 2020
Last Update Posted : September 21, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | April 20, 2020 | ||||||||||||||
First Posted Date ICMJE | April 22, 2020 | ||||||||||||||
Last Update Posted Date | September 21, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | August 6, 2020 | ||||||||||||||
Estimated Primary Completion Date | September 1, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Response Rate in PD-L1 negative melanoma [ Time Frame: 5 Years ] The primary endpoint for this study is overall response rate in PDL1 negative melanoma to combination anti-PD-L1 therapy and anti-VEGF therapy by RECIST criteria. The proportion of patients with complete response or partial response as best response to therapy will be summarized and presented with a two-sided, 90% Wald confidence interval.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
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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 | A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma | ||||||||||||||
Official Title ICMJE | A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma | ||||||||||||||
Brief Summary | This research study is studying a combination of two drugs that change the immune system and tumor as a possible treatment for metastatic or unresectable stage III or IV cutaneous melanoma. The names of the study drugs involved in this study are:
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Detailed Description | The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved atezolizumab for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved bevacizumab for this specific disease but it has been approved for other uses. Atezolizumab and bevacizumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells and stop the growth of cancer. Atezolizumab and bevacizumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Atezolizumab and Bevacizumab
The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits.
Treatment will be administered on an outpatient basis Study treatment will continue until study doctors decide to stop therapy due to criteria which may include disease progression, adverse events or changes in condition. Participants will be followed for survival health information following treatment until the study ends, which could be approximately 5 years from start of treatment Interventions:
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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 | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
30 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | September 1, 2025 | ||||||||||||||
Estimated Primary Completion Date | September 1, 2024 (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 | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04356729 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-604 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Elizabeth Buchbinder, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Elizabeth Buchbinder, Dana-Farber Cancer Institute, Sponsor Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Elizabeth Buchbinder, MD | ||||||||||||||
Original Study Sponsor ICMJE | Elizabeth Buchbinder | ||||||||||||||
Collaborators ICMJE | Genentech, Inc. | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | September 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |