NeoVax + CDX-301 and Nivolumab in Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT04930783|
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : March 18, 2022
This research study is studying the drugs called NeoVax (a new type of personalized neoantigen vaccine) in combination with CDX-301 and Nivolumab as a possible treatment for melanoma.
The names of the study drugs involved in this study are:
- Personalized Neoantigen peptides (which combined with poly-ICLC make the vaccine NeoVax)
- Poly-ICLC (Hiltonol)
- Nivolumab (Opdivo)
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Metastatic Melanoma||Drug: CDX-301 Biological: NEOVAX Drug: Nivolumab||Phase 1|
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 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.
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 as a treatment option for metastatic 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 is an antibody that prevents 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 20 people will take part in this research study
Celldex Therapeutics is supporting this research by providing CDX-301.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of NeoVax in Combination With CDX-301 and Nivolumab and in Patients With Advanced Melanoma|
|Actual Study Start Date :||January 3, 2022|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2027|
Experimental: CDX-301 + Neovax + Nivolumab
Administered as an injection given underneath the skin
Personalized neoantigen vaccine administered as an injection given underneath the skin
Administered intravenously (IV)
Other Name: Opdivo
- Rate of Dose Limiting Toxicity (DLT) [ Time Frame: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation ]Based on the CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
- Recommended maximum tolerated dose (MTD) [ Time Frame: Up to 12 weeks for each dosing cohort ]Highest dose of CDX-301 that did not cause a dose limiting toxicity
- Neoantigen-specific cellular immune responses [ Time Frame: Enrollment to end of treatment up to 24 weeks ]Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
- Anti-tumor activity at Week 24 [ Time Frame: Week 24 ]Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
- Response conversion rate (RCR) at Week 24 [ Time Frame: Week 24 ]Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
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): NCT04930783
|Contact: Patrick A Ott, MD, PhD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Patrick A Ott, MD 617-632-5055 Patrick_Ott@dfci.harvard.edu|
|Principal Investigator: Patrick A Ott, MD, PhD|
|Principal Investigator:||Patrick A Ott, MD, PhD||Dana-Farber Cancer Institute|