Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
CoImmune
Study ID
NCT04203901
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Renal Cell Carcinoma

Eligibility Criteria

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

Interventions

  • CMN-001 — BIOLOGICAL
    Autologous Dendritic Cell Therapy
  • Nivolumab+Ipilimumab — BIOLOGICAL
    anti-PD-1 and anti-CTLA4 antibodies
  • Lenvatinib+Everolimus — DRUG
    TKI+mTOR inhibitors

Study Details

CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic cells, which have been co-electroporated with both in vitro transcribed (IVT) RNA from an autologous tumor specimen and CD40L RNA. CMN-001 is indicated for treatment of intermediate/poor risk patients with advanced renal cell carcinoma (RCC) in combination with nivolumab plus ipilimumab as first line therapy and in combination with lenvatinib plus everolimus as 2nd line therapy post 1st line failure.

Key Dates

Start date
Jul 22, 2020
Status verified
Sep 2023
Primary completion
Sep 28, 2023
Completion
Sep 28, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Arm
    CMN-001 dosing (1x10\^7 DC/dose) is initiated at Visit 2 during 1st line therapy and through 2nd line therapy. CMN-001 is administered as 1 dose every 3 weeks for 3 doses (Induction phase), followed by maintenance doses, 1 every 4 weeks for 7 doses (Maintenance phase), followed by booster doses, 1 dose every 12 weeks (Booster phase). 1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression, 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.
  • Active Comparator: Standard Treatment
    1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.

Primary Outcome Measure

Overall Survival [ Time Frame: Through study completion, an average of 2 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Mayo ClinicRochesterMinnesota55905-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Westchester Medical CenterValhallaNew York10595-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Houston MethodistHoustonTexas77030-
MD Anderson Cancer CenterHoustonTexas77030-
West Virginia University Cancer InstituteMorgantownWest Virginia26506-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAMayo Clinic· Rochester, MNSUNY Upstate Medical University· Syracuse, NYWestchester Medical Center· Valhalla, NYUPMC Hillman Cancer Center· Pittsburgh, PA

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