AzTrials
AzTrials

Metastatic Prostate AdenocarcinomaPhase 2NCT05445609

Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase 2 study testing VLP-encapsulated TLR9 Agonist CMP-001, and Nivolumab in people with Metastatic Prostate Adenocarcinoma and Stage IV Prostate Cancer AJCC v8, run by Emory University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

This phase II trial tests whether vidutolimod with nivolumab works to destroy tumor cells in patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Nivolumab is an antibody working by attaching to and blocking a molecule called PD 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VLP-encapsulated TLR9 Agonist CMP-001, and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
7 Jun 2023to 23 Jun 2029
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Male >= 18 years of age
  • Histologically confirmed adenocarcinoma of the prostate with metastatic disease
  • Subjects who are refractory to a novel antiandrogen therapy (abiraterone, darolutamide, enzalutamide and/or apalutamide) and have failed at least 1 taxane based chemotherapy regimen (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen)
  • Prior orchiectomy or serum testosterone levels < 50 ng/dL determined within 4 weeks prior to start of study drug
  • Having measurable disease per RECIST 1.1 (at least one additional lesion >= 0.5 cm amenable to repeated IT injection per investigator)
  • Eastern Cooperative Oncology Group performance status of 0 or 1
Show all 18Show fewer
  • Neutrophil count >= 1,000/mm^3 (within 4 weeks prior to the first dose of CMP-001)
  • Platelet count >= 100,000/mm^3 (within 4 weeks prior to the first dose of CMP-001)
  • Hemoglobin concentration >= 9 g/dL (within 4 weeks prior to the first dose of CMP-001)
  • Total bilirubin =< 1.5 times the upper limit of normal (ULN) with the following exception: subjects with Gilbert Disease serum bilirubin >= 3 times ULN (within 4 weeks prior to the first dose of CMP-001)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the ULN or =< 5 times the ULN for patients with active liver metastases (within 4 weeks prior to the first dose of CMP-001)
  • Serum creatinine =< 1.5 times the ULN or calculated creatinine clearance >= 40 mL/min (>= 0.67 mL/sec) using the Cockcroft-Gault equation (within 4 weeks prior to the first dose of CMP-001)
  • Subjects should have an international normalized ratio (INR) or a partial thromboplastin time (PTT) =< 1.5 x ULN unless the subject is receiving anticoagulant therapy (within 4 weeks prior to the first dose of CMP-001). Subjects on anticoagulant therapy should have a prothrombin time (PT) or PTT within therapeutic range of intended use and no history of severe hemorrhage. Patients who require therapeutic anticoagulation and cannot discontinue anticoagulation safely during the day prior, day of, and day after injection are excluded. Patients requiring anticoagulation with warfarin are excluded unless they can be transitioned to an alternative anticoagulant (e.g., low molecular weight heparin or direct oral anticoagulants) prior to enrollment. Antiplatelet agents (e.g., aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (i.e., they are allowed)
  • Willingness to provide pre- and post-treatment fresh tumor biopsies, if safe and medically feasible
  • Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of CMP-001
  • Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
  • Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer >= 2 weeks before the start of study therapy. (No radiotherapy to CMP-001 injection site within 4 weeks)
  • Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Who cannot join

  • Pathological finding consistent with pure small cell, neuroendocrine carcinoma of prostate or any other histology different from adenocarcinoma
  • Requires systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 7 days prior to the first dose of CMP-001 on C1D1
  • Subjects who are currently receiving steroids at a prednisone-equivalent dose of =< 10 mg/day do not need to discontinue steroids prior to enrollment
  • Replacement doses, topical, ophthalmologic and inhalational steroids are permitted
  • History of immune-related adverse event (AE) that required permanent discontinuation of anti-PD1/PDL1 antibody
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis
Show all 23Show fewer
  • Patients with active autoimmune disease
  • Known history of immunodeficiency
  • Known additional malignancy that is progressing or requires active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, ductal carcinoma in situ, non-invasive bladder cancer and thyroid cancer (except anaplastic)
  • Untreated, symptomatic, or growing central nervous system (CNS) metastases
  • Patients with treated and stable (defined as non-progression on a restaging contrast enhanced magnetic resonance imaging (MRI) or computed tomography (CT) at least 30 days after CNS directed therapy) CNS disease are eligible to enroll
  • Patients with treated and stable CNS disease enrolled on study must be willing to undergo restaging contrast-enhanced CT or MRI every 12 weeks
  • Prior allogenic tissue/solid organ transplant
  • Known infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected
  • Received a live virus vaccination within 30 days prior to the first dose of CMP-001 on D1. Seasonal flu vaccines that do not contain live virus or COVID vaccines that administered more than 1 week prior to first dose of CMP-001 on D1 the are permitted
  • Active infection requiring systemic therapy
  • Severe uncontrolled cardiac disease within 6 months prior to consent, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident. Implanted or continuous use of a pacemaker or defibrillator
  • Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial
  • Adverse event related to previously administered anti-cancer therapy that has not resolved to < grade 2 prior to the first dose of CMP-001 on day 1 (D1)
  • Participation in another clinical study of an investigational anti-cancer therapy or device within 28 days prior to the first dose of CMP-001 on D1
  • Received chemotherapy, radiation therapy, or biological anti-cancer therapy within 14 days prior to the first dose of CMP-001 on W1D1
  • Received previous CMP-001 treatment or anti-PD1/PDL1
  • Expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of CMP-001

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: A Single Arm Study of Vidutolimod (CMP-001) With Nivolumab in Patients With Metastatic Castration Resistant Prostate Cancer

This phase II trial tests whether vidutolimod with nivolumab works to destroy tumor cells in patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Nivolumab is an antibody working by attaching to and blocking a molecule called PD 1. PD 1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies (proteins in the immune system which act to stop infection harming the body) that block PD 1 can potentially prevent PD 1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Vidutolimod (CMP-001) is a Toll-like receptor 9 (TLR9) agonist, with the ability to generate tumor-targeted T cells capable of killing a tumor both locally and systemically in combination with checkpoint inhibitors (nivolumab, in this case), thus potentially improving outcomes for people whose tumors are progressing. Giving nivolumab and vidutolimod may kill more cancer cells in patients with metastatic prostate cancer.

Read the detailed description

Primary Objective:

  1. To evaluate the safety and tolerability of vidutolimod (CMP-001) in combination with nivolumab in patients with metastatic castration resistant prostate cancer.

Secondary Objectives:

  1. To evaluate prostate-specific antigen (PSA) response rate. II.To evaluate PSA undetectable rate. III. To evaluate time to PSA progression according to PCWG3. IV. To evaluate the confirmed objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
  2. To evaluate the 1-year radiographic progression free survival (rPFS) according to PCWG3.

VI. To determine the 1-year overall survival (OS). VII. To evaluate the confirmed ORR by immune-related RECIST (irRECIST).

Exploratory Objective:

  1. To evaluate the effect of treatment on the following changes, and others:

Ia. Numbers of CD8 T-cells in tumors; Ib. Dendritic cell activation status (CD80, CD86, CD40) in tissue biopsy; Ic. Tumor specific T-cells in the blood (human leukocyte antigen [HLA]-DR+/CD38+ with T-cell receptor [TCR] sequencing).

OUTLINE:

Patients receive vidutolimod subcutaneously (SC) on days 1 and 7 of cycle 1, intratumorally (IT) on day 14 of cycle 1 and days 1 and 14 of cycle 2, and then SC on day 1 of subsequent cycles. Patients also receive nivolumab intravenously (IV) over 30 minutes on days 1 and 14 of cycle 2 and on day 1 of subsequent cycles. Cycles of nivolumab repeat every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cycles of vidutolimod repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed up for 30 days and then every 12 weeks thereafter.

Being tested
VLP-encapsulated TLR9 Agonist CMP-001,, Nivolumab
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • VLP-encapsulated TLR9 Agonist CMP-001,Drug

    Also called ARB-1598, CMP-001, CYT 003, CYT-003

    Given SC or IT

  • NivolumabBiological

    Also called 946414-94-4, BMS-936558, CMAB819, MDX-1106

    Given IV

Study groups in NCT05445609
Study groupRoleWhat they receive
Treatment ((vidutolimod, nivolumab)ExperimentalPatients receive vidutolimod SC on days 1 and 7 of cycle 1, IT on day 14 of cycle 1 and days 1 and 14 of cycle 2, and then SC on day 1 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 14 of cycle 2 and on day 1 of subsequent cycles. Cycles of nivolumab repeat every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cycles of vidutolimod repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Receives: Drug: VLP-encapsulated TLR9 Agonist CMP-001,; Biological: Nivolumab

What is being measured

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

  1. Safety of Treatment

    Will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance.

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Serum prostate-specific antigen (PSA) response

    Defined as: PSA decline >= 25%, according to PCWG3. Will be calculated along with 95% exact confidence intervals (CI).

    Measured: Up to 24 weeks from treatment initiation

  2. Radiographic progression free survival (rPFS)

    Will be determined by applicable disease criteria or death, according to PCWG3, and estimated with the Kaplan-Meier method with time-specific (e.g., 6-month, 12-month) rate estimated with 95% CI.

    Measured: At 1 year

  3. Overall survival (OS)

    Will be estimated with the Kaplan-Meier method with time-specific (e.g., 6-month, 12-month) rate estimated with 95% CI.

    Measured: At 1 year

  4. Objective response rate (ORR)

    Will be determined by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST),

    Measured: Up to 24 months

  5. ORR

    Will be determined based on RECIST version 1.1

    Measured: Up to 24 months

Timeline

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

  1. First posted6 Jul 2022
  2. Study start7 Jun 2023
  3. Primary completion23 Jun 2028 (estimated)
  4. Study completion23 Jun 2029 (estimated)

Why it stopped: Per sponsor memo screening and enrollment of new patients for all ongoing Regeneron sponsored studies with vidutolimod are being paused until further notice

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445609
Sponsor's protocol ID
STUDY00004226
Other IDs
NCI-2022-05290, WINSHIP5576-22
Status last verified
Sep 2026
First submitted
28 Jun 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VLP-encapsulated TLR9 Agonist CMP-001, and Nivolumab in people with Metastatic Prostate Adenocarcinoma and Stage IV Prostate Cancer AJCC v8, run by Emory University 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 18 inclusion and 23 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: paused, as of the sponsor's last update on 13 Oct 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?

Results are not available in the source record.

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?

Safety of Treatment (time frame: Up to 24 months). 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 NCT05445609.

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 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in