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MelanomaPhase 2NCT04401995

Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab

A Phase 2 study testing Vidutolimod (CMP-001), Nivolumab and [18F]F-AraG PET/CT in people with Melanoma, run by Diwakar Davar at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Vidutolimod (CMP-001), Nivolumab and [18F]F-AraG PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
2 Sep 2020to 16 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the study.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Willingness to undergo [18F]F-AraG PET imaging at pre- and week 3 timepoints.
  • Diagnosis of histologically or cytologically confirmed diagnosis of cutaneous melanoma belonging to one of the following AJCC TNM stages:
  • Tx or T1-4 and
  • N1b, or N1c, or N2b, or N2c, or N3b, or N3c and
Show all 33Show fewer
  • M0
  • Patients are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal metastasis; or at the time of clinical detected nodal recurrence; and may belong to any of the following groups:
  • Primary cutaneous melanoma with clinically apparent regional lymph node metastases.
  • Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin.
  • Clinically detected primary cutaneous melanoma involving multiple regional nodal groups.
  • Clinical detected nodal melanoma (if single site) arising from an unknown primary.
  • In-transit and/or satellite metastases with regional lymph node involved permitted if considered potentially surgically resectable at baseline.
  • NOTE: Patients whose sole site of disease is regional lymph node involvement of the parotid LN basin are not eligible for this neoadjuvant study.
  • NOTE: Patients with only in-transit and/or satellite metastases without regional lymph node involvement are not eligible for this neoadjuvant study.
  • NOTE: Determination of potential resectability must be made at baseline to be eligible for this neoadjuvant study.
  • NOTE: Patients with mucosal and/or uveal melanoma are not permitted to enroll. Patients with melanomas of unknown primary may be enrolled at the discretion of the treating investigator in discussion with Principal Investigator.
  • Presence of injectable and measurable disease based on RECIST 1.1.
  • Willing to undergo tumor biopsy (core, punch, incisional or excisional). Patients must undergo biopsy (core, punch) or open biopsy (incisional, excisional) within 4 weeks of registration on the study and at W4-5.
  • Performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function as defined below performed on screening labs obtained within 4 weeks of registration.
  • Absolute neutrophil count (ANC) ≥1,500 /mcL
  • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
  • Platelets ≥100,000 / mcL
  • Serum creatinine or Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
  • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN.
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN.
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 26 weeks after the last dose of study medication (Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of study therapy.
  • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Who cannot join

  • History of uveal or mucosal melanoma.
  • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Show all 18Show fewer
  • Note: Subjects with autoimmune disorders of Grade 4 while on prior immunotherapy will be excluded. Subjects who developed autoimmune disorders of Grade ≤ 3 may enroll if the disorder has resolved to Grade ≤1 and the subject has been off systemic steroids at doses >10 mg/d for at least 2 weeks.
  • Active (i.e., symptomatic or growing) central nervous system (CNS) metastases.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has a systemic disease that requires systemic pharmacologic doses of corticosteroids greater than 10mg daily prednisone (or equivalent). Subjects who are currently receiving steroids at a dose of ≤10mg daily do not need to discontinue steroids prior to enrollment Subjects that require topical, ophthalmologic and inhalational steroids would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. Subjects who require active immunosuppression (greater than steroid dose discussed above) for any reason are excluded.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 26 weeks after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or BRAF/MEK inhibitor. Prior treatment with ipilimumab or interferon alfa is allowed. Patients with history of allergic or hypersensitivity reaction to interferon alfa or ipilimumab are also excluded.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected. Patients with treated Hepatitis B/C with no evidence of active infection may be enrolled.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Randomized Neoadjuvant Pilot Phase II Study of TLR9 Agonist Vidutolimod (CMP-001) in Combination With Nivolumab vs. Nivolumab in Stage IIIB/C/D Melanoma Patients With an Integrated Imaging Biomarker

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.

Read the detailed description

This is a phase II pilot study designed to compare the pCR rate of two neoadjuvant immunotherapies in high-risk resectable melanoma with two integrated biomarkers. The integrated [18F]F-AraG imaging biomarker images activated CD8+ T cells. The CD8+ T cell density biomarker quantitates CD8+ T Cells using an automated method. The primary purpose of the study is to describe the correlation between pCR and the distribution of either biomarkers in patients receiving either neoadjuvant Vidutolimod (CMP-001)/nivolumab or neoadjuvant nivolumab.

Patients with stage IIIB-IIID cutaneous (or unknown primary) melanoma with palpable nodal disease who have yet to undergo definitive surgery are eligible to enroll. Patients with nodal relapse including those who have received prior adjuvant IFN and/or ipilimumab are eligible to enroll.

Suitable patients will be identified pre-operatively. Patients will undergo a 28 day screening evaluation including surgical assessment, clinical assessment, systemic/CNS staging scans, and laboratory studies to confirm suitability. Patients will undergo biopsies of both planned injected and uninjected lesions (Arm A) and target lesion (Arm B). Biopsies of these lesions will occur pre-treatment, at W3 or W4 and the target lesion(s) will be resected at the time of surgery.

Eligible patients will be randomized 1:1 to receive Arm A (neoadjuvant Nivolumab/(CMP) vs. Arm B (neoadjuvant Nivolumab) during the (Prime Phase) pre-operatively. Patients randomized to Arm A will receive: Nivolumab 240mg IV q2 x3 and CMP-001 5mg SC 1st dose then 10mg IT 2nd-7th doses (7 weeks). Patients randomized to Arm B will receive: Nivolumab 240mg IV q2 x3 (6 weeks).

[18F]F-AraG PET-CT scan (18-F PET) is an integrated biomarker and will be performed at 2 imaging time-points: pre-treatment (pre-W1) and on-treatment (W2). At each imaging timepoint, [18F]F-AraG will be administered by a licensed nuclear medicine technologist under the supervision of a nuclear medicine physician on an outpatient basis. Each patient will receive a single bolus injection of 5 mCi [18F]F-AraG IV into a hand or arm vein. At Screening and W2 imaging timepoints, following [18F]F-AraG injection, a 30-min static PET-CT scan will be performed covering the brain to the upper legs.

For CD8+ T cell density assessments, patients will undergo biopsies at 2 timepoints: pre-treatment (Screening) and on-treatment (W3 or W4). In Arm A, patients will undergo biopsies of planned injected and a 2nd uninjected lesion. At each imaging timepoint, biopsies will be performed.

Following the Prime Phase and restaging systemic scans, patients will undergo surgical resection.

Post-operatively, patients will continue to receive maintenance therapy (Boost Phase) per randomization. In the Boost Phase, patients randomized to Arm A (neoadjuvant Nivolumab/(CMP) will receive 480mg IV q4 x12 along with Vidutolimod (CMP-001) 5mg SC q4 x12 over a 48 week period; while patients randomized to Arm B (neoadjuvant Nivolumab) will receive Nivolumab (480mg IV q4 x12 over a 48 week period). In the post-operative period, CMP-001 will be administered subcutaneously (Arm A only).

Conditions
Melanoma
Being tested
Vidutolimod (CMP-001), Nivolumab, [18F]F-AraG PET/CT
Keywords
residual volume of tumor (RVT), standard uptake value (SUV)
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • NivolumabBiological

    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/CTOther

    [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 groups in NCT04401995
Study groupRoleWhat they receive
Nivolumab and Vidutolimod (CMP-001) Combination with [18F]F-AraG PET/CTExperimentalPrime 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.
Receives: Drug: Vidutolimod (CMP-001); Biological: Nivolumab; Other: [18F]F-AraG PET/CT
Nivolumab with [18F]F-AraG PET/CTExperimentalPrime 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.
Receives: Biological: Nivolumab; Other: [18F]F-AraG PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic Response

    Percentage of patients who experience Pathologic CR (pCR), Partial PR (pPR), or Pathologic NR (pNR) per Immune-related Pathologic Response Criteria. pCR is defined as 0% RVT (residual tumor volume) remaining in post-therapy specimen. pPR is defined a 10%<%RVT< 50%. pNR is defined as %RVT>50%.

    Measured: At the time of surgery (Week 8-10)

  2. Distant-metastasis Free Survival (DMFS)

    The length of time from initiation of treatment until distant-metastasis of melanoma or death.

    Measured: Up to 5 years

  3. Major Pathologic Response Rate (MPR)

    Major Pathologic Response (MPR) is defined as %RVT≤10%.

    Measured: At the time of surgery (Week 8-10)

Secondary outcomes (21)

  1. Relapse-Free Survival (RFS)

    The length of time from initiation of treatment until melanoma relapse or death.

    Measured: Up to 24 months

  2. 6-month Relapse-Free Survival (RFS)

    Percentage of patients without disease relapse at 6 months from start of treatment.

    Measured: At 6-months

  3. 12-month Relapse-Free Survival (RFS)

    Percentage of patients without disease relapse at 12 months from start of treatment.

    Measured: At 12-months

  4. 24-month Relapse-Free Survival (RFS)

    Percentage of patients without disease relapse at 24 months from start of treatment.

    Measured: At 24 months

  5. Overall Survival (OS)

    The length of (survival) time from the start of treatment until death from any cause.

    Measured: Up to 24 months

  6. 6-month Overall Survival (OS)

    Percentage of patients alive at 6 months from the start of treatment until death from any cause.

    Measured: At 6 months

  7. 12-month Overall Survival (OS)

    Percentage of patients alive at 12 months from the start of treatment until death from any cause.

    Measured: At 12-months

  8. 24-month Overall Survival (OS)

    Percentage of patients alive at 24 months from the start of treatment until death from any cause.

    Measured: At 24 months

  9. Adverse Events at Least Possibly Related to Study Treatment

    Toxicities defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 are adverse events classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded and the frequency of toxicities will be tabulated for the study population.

    Measured: Up to 47 months and 14 days

  10. SUVmax -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline

  11. SUVpeak -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline

  12. SUVmean -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline

  13. SUVtotal -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVtotal. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline

  14. SUVmax -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: Post Treatment - At 5 weeks

  15. SUVpeak -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: Post Treatment - At 5 weeks

  16. SUVmean -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: Post Treatment - At 5 weeks

  17. SUVtotal -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: Post Treatment - At 5 weeks

  18. Change in SUVmax -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV) , SUVpeak, SUVmean, and SUVtotal.The max, peak, mean and total values for each patient will be used to determine the average standard uptake values for the study population. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline and Post Treatment at 5 weeks

  19. Change in SUVpeak -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVpeak. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: Post Treatment - At 5 weeks

  20. Change in SUVmean -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVmean. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline and Post Treatment - At 5 weeks

  21. Change in SUVtotal -Tumor PET Response Via [18F]F-AraG

    [18F]F-AraG is an experimental PET imaging agent. Tumor PET response will be assessed via standard uptake values (SUV), SUVtotal. The possible range of SUV values is between 0 - 100. Higher SUV correlates with greater malignancy.

    Measured: At Baseline and Post Treatment - At 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start2 Sep 2020
  3. Primary completion16 Aug 2024
  4. Study completion16 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401995
Sponsor's protocol ID
HCC 20-049
Status last verified
Jun 2026
First submitted
18 May 2020
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vidutolimod (CMP-001), Nivolumab and [18F]F-AraG PET/CT in people with Melanoma, run by Diwakar Davar at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Response (time frame: At the time of surgery (Week 8-10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04401995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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