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Merkel Cell CarcinomaPhase 2NCT04916002

A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer

A Phase 2 study testing vidutolimod and cemiplimab in people with Merkel Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 24 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are: How many participants' cancers respond to vidutolimod together with cemiplimab? Is vidutolimod together with cemiplimab safe and well-tolerated? How… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vidutolimod and cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
24 sitesin 2 countries
Study dates
30 Nov 2021to 31 Oct 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

  • Participants enrolled in the study must meet all of the following inclusion criteria to be eligible.
  • Histopathologically-confirmed diagnosis of cancer, as defined by the protocol.
  • Measurable disease, as defined by RECIST v1.1 and as defined in the protocol. Note: CSCC, MCC and BCC subjects without radiographically measurable disease are not excluded if there is at least 1 lesion ≥ 10 mm in at east 1 dimension documented by color photography.
  • Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening.

Who cannot join

  • Participants presenting with any of the following will not qualify for entry into the study:
  • Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.
  • Had major surgeries (including complete oncologic resection) within last 4 weeks prior to enrollment, and/or have not recovered adequately from the toxicities and/or complications from the intervention. Minor surgeries (including routine resections of early stage CSCCs and BCCs that may be due to field cancerization) require a 7-day washout.
  • Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 15 days before first dose of study treatment on W1D1, as defined in the protocol.
  • History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
  • Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency.
Show all 13Show fewer
  • Active pneumonitis or history of noninfectious pneumonitis that required steroids.
  • Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted.
  • Known history of immunodeficiency.
  • Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.
  • Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
  • Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).
  • NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States20 sites

  • VA Maryland Health Care System

    Baltimore, Maryland, 20814

  • University of Alabama

    Birmingham, Alabama, 35294

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ohio State University

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • East Carolina University

    Greenville, North Carolina, 27858

  • Oncology Consultants

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • GenesisCare USA

    Jacksonville, Florida, 32204

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92037-0845

  • Dartmouth Clinical Trial Office

    Lebanon, New Hampshire, 03756

  • University of California

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • University of Utah Huntsman Cancer Center

    Salt Lake City, Utah, 84112

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

Australia4 sites

  • St. Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Peter MacCallum Cancer Centre (PMCC) and The Royal Melbourne Hospital

    Melbourne, Victoria, 3050

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Multicenter, Open-label, Phase 2 Study of Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Cemiplimab in Subjects With Selected Types of Advanced or Metastatic Cancer

The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are:

  • How many participants' cancers respond to vidutolimod together with cemiplimab?
  • Is vidutolimod together with cemiplimab safe and well-tolerated?
  • How well does vidutolimod together with cemiplimab treat participants' cancer?

Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.

Read the detailed description

Former Sponsor Checkmate Pharmaceuticals Note: Early termination planned on 31Oct2024 due to study drug supply

Being tested
vidutolimod, cemiplimab
Keywords
vidutolimod, Metastatic Cancer, Advanced Cancer, MCC, CSCC, BCC, TNBC, NSCLC, OPSCC
Medical subject headings
Carcinoma, Merkel Cell, Carcinoma, Basal Cell, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis

What participants receive

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

  • vidutolimodDrug

    Also called CMP-001

    Participants will receive vidutolimod for up to 2 years as follows: 10 mg IT weekly for 7 doses after which vidutolimod will be administered every 3 weeks (Q3W). The first dose of vidutolimod may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of vidutolimod, delivered on a weekly dosing schedule, must be completed before starting the Q3W vidutolimod dosing schedule.

  • cemiplimabDrug

    Also called Libtayo, REGN2810

    Participants will receive cemiplimab for up to 2 years as follows: 350 mg IV infusion over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.

Study groups in NCT04916002
Study groupRoleWhat they receive
Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)ExperimentalParticipants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable CSCC and who are not eligible for curative radiation will receive vidutolimod intratumoral(ly) (IT) and cemiplimab intravenous (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for CSCC (A2)ExperimentalParticipants who have progressed while receiving a programmed cell death protein 1 (PD-1)-blocking antibody or within 12 weeks of discontinuation of PD-1 blocking antibody for metastatic or locally and/or regionally advanced unresectable CSCC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)ExperimentalParticipants who have not received prior systemic therapy for metastatic or locally and/or regionally advanced unresectable MCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for MCC (B2)ExperimentalParticipants who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of the PD-1 blocking antibody, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)ExperimentalParticipants who have not received prior therapy with immune checkpoint inhibitors (iCPIs) and who must have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan [human epidermal growth factor receptor 2 (HER2)-low participants] and with adenosine diphosphate ribose polymerase (PARP) inhibitor [for BReast CAncer gene (BRCA)] for TNBC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for TNBC (C2)ExperimentalParticipants who have previously received treatment with sacituzumab govitecan (all advanced or metastatic TNBC participants), with trastuzumab deruxtecan (HER2-low participants) and with PARP inhibitor (for BRCA) and who have progressed while receiving a PD-1-blocking antibody or within 12 weeks of discontinuation of a PD-1 blocking antibody for advanced or metastatic TNBC, will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)ExperimentalParticipants who have not received prior hedgehog pathway inhibitor therapy, or prior anti-PD-1/programmed cell death ligand 1 (PD-L1) therapy and who do not wish to receive or who are not candidates for a hedgehog inhibitor, for metastatic or locally and/or regionally advanced unresectable BCC and will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E)ExperimentalParticipants with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] based on a prior PD-L1 result as determined by College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed) lab, with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ros oncogene 1 (ROS1) aberrations, and who have not received prior anti-PD-1/PD-L1 therapy and are amenable to IT therapy and do not wish to receive chemotherapy. Note: this cohort is not conducted in Europe
Receives: Drug: vidutolimod; Drug: cemiplimab
Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)ExperimentalParticipants with PD-L1 combined positive score (CPS) ≥ 1, based on a prior PD-L1 result and human papillomavirus (HPV)-positive disease based on a prior result, who have not received prior systemic therapy for recurrent/metastatic disease. Participants will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
Receives: Drug: vidutolimod; Drug: cemiplimab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

    Measured: Up to 31.5 Months

Secondary outcomes (5)

  1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death

    Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.

    Measured: Up to 31.5 months

  2. Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported:

    Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event

    Measured: Up to 31.5 months

  3. Duration of Response (DOR)

    DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator

    Measured: Up to 31.5 months

  4. Progression Free Survival (PFS)

    PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first

    Measured: Up to 31.5 months

  5. Overall Survival (OS)

    OS is defined as the time from date of first dose of study treatment to date of death

    Measured: Up to 31.5 months

Timeline

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

  1. First posted7 Jun 2021
  2. Study start30 Nov 2021
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Why it stopped: Sponsor Decision related to study drug supply

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04916002
Sponsor's protocol ID
CMP-001-009
Other IDs
2023-507344-36-01, 2023
Status last verified
May 2026
First submitted
1 Jun 2021
Last updated
9 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vidutolimod and cemiplimab in people with Merkel Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 24 sites in 2 countries.

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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Australia. 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 5 Dec 2025). 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?

Objective Response Rate (ORR) (time frame: Up to 31.5 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 NCT04916002.

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 9 Jun 2026.

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