Trials / Terminated
TerminatedNCT04203901
Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- CoImmune · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CMN-001 | Autologous Dendritic Cell Therapy |
| BIOLOGICAL | Nivolumab+Ipilimumab | anti-PD-1 and anti-CTLA4 antibodies |
| DRUG | Lenvatinib+Everolimus | TKI+mTOR inhibitors |
Timeline
- Start date
- 2020-07-22
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
- First posted
- 2019-12-18
- Last updated
- 2023-10-02
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04203901. Inclusion in this directory is not an endorsement.