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

NCT04401995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-21

No results posted yet for this study

Summary

The main goal of this research study is to determine how nivolumab and nivolumab/Vidutolimod (CMP-001) combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas.

The main goal of the PET/CT scan with 18F\]F-AraG is to evaluate how \[18F\]F-AraG uptake changes before and after administration of either nivolumab or nivolumab/CMP-001 combination.

Conditions

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.

Sponsors & Collaborators

  • Checkmate Pharmaceuticals

    collaborator INDUSTRY

  • CellSight Technologies, Inc.

    collaborator INDUSTRY

  • Diwakar Davar

    lead OTHER

Principal Investigators

  • Diwakar Davar, MD, M.Sc · University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2024-08-16
Completion
2024-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401995 on ClinicalTrials.gov