NeoVax Plus Ipilimumab in Renal Cell Carcinoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Patrick Ott, MD, PhD
Study ID
NCT02950766
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NeoVax — DRUG
    combination of Neoantigen peptides and poly-ICLC
  • Ipilimumab — DRUG
    local administration of ipilimumab

Study Details

This research study is evaluating a new type of Kidney Cancer vaccine called "Personalized NeoAntigen Cancer Vaccine"as a possible treatment for Kidney Cancer. The following intervention will be involved in this study: * Personalized Neoantigen Vaccine * Poly-ICLC (Hiltonol) * Ipilimumab

Key Dates

Start date
Mar 3, 2019
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
May 30, 2030

Study Design

Enrollment
19 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neovax in Combination with Ipilimumab
    Patients will undergo surgery with the intent to resect the primary kidney tumor Neovax is a combination of Poly-ICLC and Neoantigen Peptides Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22 * In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20 Ipilimumab will be injected within 1 cm of each NeoVax administration
  • Experimental: NeoVax alone
    Patients will undergo surgery with the intent to resect the primary kidney tumor Neovax is a combination of Poly-ICLC and Neoantigen Peptides Priming doses of NeoVax will be administered on days 1, 4, 8, 15, and 22 * In the boost phase, vaccine will be administered on days 78 (week 12) and 134 (week 20)

Primary Outcome Measure

Number of participants with dose-limiting toxicity (DLT) experienced within 49 days (7 weeks) of treatment initiation as assessed by CTCAE v4.0 [ Time Frame: 49 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Dana Farber Cancer Institute· Boston, MA

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