NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma
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ClinicalTrials.gov Identifier: NCT04930783 |
Recruitment Status :
Recruiting
First Posted : June 18, 2021
Last Update Posted : March 27, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | June 11, 2021 | ||||||||||||||
First Posted Date ICMJE | June 18, 2021 | ||||||||||||||
Last Update Posted Date | March 27, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | January 3, 2022 | ||||||||||||||
Estimated Primary Completion Date | January 31, 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 | ||||||||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma | ||||||||||||||
Official Title ICMJE | A Phase Ib Study of NeoVax in Combination With CDX-301 and Nivolumab or Pembrolizumab and in Patients With Melanoma | ||||||||||||||
Brief Summary | This research study is studying the drugs called NeoVax (a new type of personalized neoantigen vaccine) in combination with CDX-301 and Nivolumab or Pembrolizumab as a possible treatment for melanoma. The names of the study drugs involved in this study are:
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Detailed Description | The purpose of this Phase I study is to determine if it is possible to safely administer a personalized neoantigen vaccine (NeoVax) in combination with the study drug CDX-301 and Nivolumab or Pembrolizumab against melanoma by using information gained from specific characteristics of someone's own melanoma. The study will also be determining what the appropriate dose of CDX-301 to be given in combination with NeoVax and Nivolumab or Pembrolizumab. The FDA (the U.S. Food and Drug Administration) has not approved personalized neoantigen peptides, poly-ICLC , or CDX-301 as a treatment for any disease. The FDA has approved Nivolumab and Pembrolizumab as a treatment option for melanoma. It is known that melanoma cancers have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells.It is possible that these proteins used in a vaccine may induce strong immune responses, which may help someone's body fight any tumor cells that could cause the melanoma to come back in the future. The personalized Neovax vaccine will be made of protein fragments, called peptides, from an individual's mutated melanoma tumor cells mixed with Poly-ICLC. Poly-ICLC is a drug that binds proteins on the surface of certain immune cells and helps to activate the immune system. CDX-301 is a drug involved in regulating the activity and proliferation of a type of cell named dendritic cell. Dendritic cells are key in enhancing the activation of the immune system in response to the NeoVax vaccine, so the immune system has a better chance to recognize the tumor cells and attack them. Nivolumab and Pembrolizumab are antibodies that prevent cancer cells from suppressing one's immune response so that their body can attack and kill the cancer. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse for a maximum of 2 years and will be followed for 5 years since study therapy initiation It is expected that about 30 people will take part in this research study Celldex Therapeutics is supporting this research by providing CDX-301. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized 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 |
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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 |
20 | ||||||||||||||
Estimated Study Completion Date ICMJE | January 31, 2027 | ||||||||||||||
Estimated Primary Completion Date | January 31, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Eligibility to participate will be assessed at one timepoint: prior to initial core needle/surgical biopsy (Initial Registration).
Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
Exclusion Criteria:
Participants may not receive any non-oncology vaccine therapy during the period of Nivolumab (or Pembrolizumab) or NeoVax plus CDX-301 administration and until at least 8 weeks after the last dose of study therapy. Given the severity of the COVID-19 pandemic, vaccination specifically against the SARS-CoV-2 virus for the prevention of COVID-19 is ALLOWED in this study.
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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 | NCT04930783 | ||||||||||||||
Other Study ID Numbers ICMJE | 21-066 | ||||||||||||||
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 | Patrick Ott, MD, PhD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Patrick Ott, MD, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Celldex Therapeutics | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | March 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |