RecruitingPhase 1NCT04930783

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma

A Phase Ib Study of NeoVax in Combination With CDX-301 and Nivolumab or Pembrolizumab and in Patients With Melanoma

Sponsor

Dana-Farber Cancer Institute

Enrollment

30 participants

Start Date

Jan 3, 2022

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic Melanoma

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: * Personalized Neoantigen peptides (which combined with poly-ICLC make the vaccine NeoVax) * Poly-ICLC (Hiltonol) * CDX-301 * Nivolumab (Opdivo) * Pembrolizumab (Keytruda)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized cancer vaccine (NeoVax) combined with a protein (CDX-301) that boosts immune cells, alongside standard immunotherapy drugs (nivolumab or pembrolizumab), for people with advanced or high-risk melanoma. **You may be eligible if...** - You have been diagnosed with stage IIIB, IIIC, IIID, or stage IV cutaneous (skin) melanoma - Your tumor has been surgically removed or can be removed, or has at least one site accessible for biopsy - You are 18 or older and in good overall health (ECOG 0 or 1) - Any side effects from previous treatment have resolved **You may NOT be eligible if...** - You have mucosal melanoma or uveal (eye) melanoma — this study is for skin melanoma only - Your tumor cannot be biopsied or sampled - Your health is not good enough to tolerate treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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