Study Stopped
Sponsor Decision related to study drug supply
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 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
2 other identifiers
interventional
77
2 countries
24
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2021
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedStudy Start
First participant enrolled
November 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedResults Posted
Study results publicly available
December 5, 2025
CompletedDecember 5, 2025
November 1, 2025
2.9 years
June 1, 2021
October 30, 2025
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Up to 31.5 Months
Secondary Outcomes (5)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Up to 31.5 months
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Up to 31.5 months
Duration of Response (DOR)
Up to 31.5 months
Progression Free Survival (PFS)
Up to 31.5 months
Overall Survival (OS)
Up to 31.5 months
Study Arms (9)
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.
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.
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.
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.
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.
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.
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.
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
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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama
Birmingham, Alabama, 35294, United States
City of Hope
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037-0845, United States
University of California
Los Angeles, California, 90095, United States
GenesisCare USA
Jacksonville, Florida, 32204, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
VA Maryland Health Care System
Baltimore, Maryland, 20814, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Dartmouth Clinical Trial Office
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Ohio State University
Columbus, Ohio, 43210, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Oncology Consultants
Houston, Texas, 77030, United States
University of Utah Huntsman Cancer Center
Salt Lake City, Utah, 84112, United States
University of Washington
Seattle, Washington, 98109, United States
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Peter MacCallum Cancer Centre (PMCC) and The Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Terminated early due to study drug supply. Enrolled 77 of 225 planned participants. Participants only enrolled in CSCC, MCC, \& BCC cohorts at time of diagnosis. Results descriptive in nature. No conclusions can be inferred from cohorts analyzed.
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 7, 2021
Study Start
November 30, 2021
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
December 5, 2025
Results First Posted
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing