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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Diwakar Davar
Study ID
NCT04401995
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vidutolimod (CMP-001) — DRUG
    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).
  • Nivolumab — BIOLOGICAL
    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.
  • [18F]F-AraG PET/CT — OTHER
    \[18F\]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.

Study Details

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.

Key Dates

Start date
Sep 2, 2020
Status verified
Oct 2024
Primary completion
Aug 16, 2024
Completion
Aug 16, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Vidutolimod (CMP-001) Combination with [18F]F-AraG PET/CT
    Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2,4,6) for 6 weeks in combination with Vidutolimod 5mg subcutaneous 1st dose, and the remaining injections, 10mg intra-tumorally will be administered Weeks 2-7. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 2. Boost Phase - Nivolumab 480mg IV, every 4 weeks and CMP-001 5mg subcutaneous every 4 weeks up to 48 weeks.
  • Experimental: Nivolumab with [18F]F-AraG PET/CT
    Prime Phase - Nivolumab 240mg IV, every 2 weeks starting with Cycle 2 (Cycles 2, 4, 6) for 6 weeks. \[18F\]F-AraG PET/CT, single bolus injection of 5 (±10%) mCi IV into a vein, Screening and at Week 3. Boost Phase - Nivolumab 480mg IV, every 4 weeks starting from the time of surgery recovery for up to 48 weeks.

Primary Outcome Measure

Major Pathologic Response Rate (MPR) [ Time Frame: At the time of surgery (Week 8-10) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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