Experimental combo therapy shows promise in advanced cancers, but trial halted early
NCT ID NCT04916002
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether injecting vidutolimod directly into tumors plus giving cemiplimab through a vein could shrink cancers that have spread. The trial included 77 people with several types of advanced cancer. Unfortunately, the study was stopped early, so we have less information than hoped. The main goal was to see how many patients' tumors responded and to check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vidutolimod (CMP-001) and cemiplimab (Libtayo)
- What this could lead to
- If successful, this combination could offer a new treatment option for several advanced cancers by boosting the immune system to attack tumors.
- What could go wrong
- The trial was terminated early, so results are limited. It is unclear if the combination is effective or safe; side effects from immune activation can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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77 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: Participants enrolled in the study must meet all of the following inclusion criteria to be eligible. 1. Histopathologically-confirmed diagnosis of cancer, as defined by the protocol. 2. 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. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening. Key Exclusion Criteria: Participants presenting with any of the following will not qualify for entry into the study: 1. 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. 2. 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. 3. 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. 4. History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody. 5. 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. 6. Active pneumonitis or history of noninfectious pneumonitis that required steroids. 7. 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. 8. Known history of immunodeficiency. 9. Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol. 10. Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment. 11. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Dartmouth Clinical Trial Office
Lebanon, New Hampshire, 03756, United States
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East Carolina University
Greenville, North Carolina, 27858, United States
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Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
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GenesisCare USA
Jacksonville, Florida, 32204, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Norton Cancer Institute
Louisville, Kentucky, 40202, United States
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OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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Ohio State University
Columbus, Ohio, 43210, United States
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Oncology Consultants
Houston, Texas, 77030, United States
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Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
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Peter MacCallum Cancer Centre (PMCC) and The Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
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St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
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UC San Diego Moores Cancer Center
La Jolla, California, 92037-0845, United States
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of California
Los Angeles, California, 90095, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
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University of Utah Huntsman Cancer Center
Salt Lake City, Utah, 84112, United States
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University of Washington
Seattle, Washington, 98109, United States
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VA Maryland Health Care System
Baltimore, Maryland, 20814, United States
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Other studies related to the condition(s) this trial covers.
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