Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination with Nivolumab Vs. Nivolumab

PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 2, 2020

Primary Completion Date

August 16, 2024

Study Completion Date

August 16, 2024

Conditions
Melanoma
Interventions
DRUG

Vidutolimod (CMP-001)

A molecule comprised of a 30 nucleotide strand, flanked by 10 guanines on either end. The nucleotide strand is surrounded by a Qβ viral-like protein. The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).

BIOLOGICAL

Nivolumab

a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.

OTHER

[18F]F-AraG PET/CT

\[18F\]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. It has several advantages over conventional \[18F\] and existing small molecule PET agents being investigated for immuno-monitoring. \[18F\]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

All Listed Sponsors
collaborator

Checkmate Pharmaceuticals

INDUSTRY

collaborator

CellSight Technologies, Inc.

INDUSTRY

lead

Diwakar Davar

OTHER