NCT04203901

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Terminated Phase 2 Last updated 2 October 2023

What this trial tests

Phase 2 trial testing CMN-001 in Advanced Renal Cell Carcinoma in 16 participants. Terminated before completion.

Timeline

22 July 2020

Primary endpoint
28 September 2023

28 September 2023

Quick facts

Lead sponsor	CoImmune
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	22 July 2020
Primary completion	28 September 2023
Estimated completion	28 September 2023
Sites	9 locations across United States

Drugs / interventions tested

• CMN-001 — full drug profile →
• Nivolumab+Ipilimumab
• Lenvatinib+Everolimus — full drug profile →

Conditions studied

• Advanced Renal Cell Carcinoma — all drugs for Advanced Renal Cell Carcinoma →

Sponsor

CoImmune — full company profile →

Who can join

18 and older, any sex, with Advanced Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond conventional immune-checkpoint inhibition - novel immunotherapies for renal cell carcinoma.
   Braun DA, Bakouny Z, Hirsch L, Flippot R, et al · · 2021 · cited 263× · PMID 33437048 · DOI 10.1038/s41571-020-00455-z
2. Exploiting innate immunity for cancer immunotherapy.
   Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w
3. Trial watch: Dendritic cell (DC)-based immunotherapy for cancer.
   Laureano RS, Sprooten J, Vanmeerbeerk I, Borras DM, et al · · 2022 · cited 101× · PMID 35800158 · DOI 10.1080/2162402x.2022.2096363
4. Dendritic Cell Vaccines: A Shift from Conventional Approach to New Generations.
   Lee KW, Yam JWP, Mao X. · · 2023 · cited 75× · PMID 37681880 · DOI 10.3390/cells12172147
5. New approaches to first-line treatment of advanced renal cell carcinoma.
   George DJ, Lee CH, Heng D. · · 2021 · cited 30× · PMID 34527080 · DOI 10.1177/17588359211034708
6. The Ins and Outs of Messenger RNA Electroporation for Physical Gene Delivery in Immune Cell-Based Therapy.
   Campillo-Davo D, De Laere M, Roex G, Versteven M, et al · · 2021 · cited 30× · PMID 33809779 · DOI 10.3390/pharmaceutics13030396
7. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
8. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.
   Aldin A, Besiroglu B, Adams A, Monsef I, et al · · 2023 · cited 20× · PMID 37146227 · DOI 10.1002/14651858.cd013798.pub2