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
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| ClinicalTrials.gov Identifier: NCT04916002 |
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Recruitment Status :
Recruiting
First Posted : June 7, 2021
Last Update Posted : April 4, 2023
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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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 an end of treatment visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Merkel Cell Carcinoma Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Triple Negative Breast Cancer Non-Small Cell Lung Cancer | Drug: vidutolimod Drug: cemiplimab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | March 7, 2027 |
| Estimated Study Completion Date : | March 7, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)
Participants who have not received prior systemic therapy for CSCC will receive vidutolimod intratumoral(ly) (IT) and cemiplimab intravenous (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for CSCC (A2)
Participants who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for CSCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)
Participants who have not received prior systemic therapy for MCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for MCC (B2)
Participants who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for MCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)
Participants who have not received prior therapy with immune checkpoint inhibitors (iCPIs) for TNBC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for TNBC (C2)
Participants who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for TNBC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)
Participants who have not received prior hedgehog pathway inhibitor therapy, nor prior therapy with immune checkpoint inhibitors (iCPIs), for metastatic or locally and/or regionally advanced unresectable BCC will receive vidutolimod IT and cemiplimab IV according to the treatment schedule until a reason for treatment discontinuation is reached.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Experimental: Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC)(E)
Participants with advanced NSCLC (metastatic or locally advanced who are not candidates for definitive chemoradiation, nor candidates for surgical resection), whose tumors have high PD-L1 expression (TPS ≥50%, as determined by a CAP/CLIA or equivalently licensed lab), have not received prior anti-PD-1/programmed cell death ligand 1 (PD-L1) therapy, and are amenable to IT therapy for advanced NSCLC. Patients with EGFR, ALK or ROS1 aberrations, are not eligible.
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Drug: vidutolimod
Participants will receive vidutolimod 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.
Other Name: CMP-001 Drug: cemiplimab Participants will receive cemiplimab 350 mg IV over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Other Names:
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Primary Outcome Measures :
- Objective response rate (ORR) with vidutolimod in combination with cemiplimab in study participants with metastatic or advanced/unresectable CSCC, MCC, BCC, NSCLC or TNBC [ Time Frame: Up to 42 Months ]CSCC is defined as cutaneous squamous cell carcinoma, MCC is defined as Merkel cell carcinoma, BCC is defined as Basal cell carcinoma, NSCLC is defined as Non-small cell lung cancer and TNBC is defined as triple negative breast cancer. ORR is further defined as the proportion 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.)
Secondary Outcome Measures :
- Safety and tolerability of vidutolimod administered by IT injection in combination with cemiplimab in the study participants [ Time Frame: Up to 42 Months ]Safety and tolerability is defined as the presence of Adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
- Efficacy of vidutolimod in combination with cemiplimab in the study participants [ Time Frame: Up to 42 Months ]Efficacy is measured by: Duration of response (DOR), 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 Response in injected and noninjected target lesions per RECIST v1.1. Progression-free survival (PFS), 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. Overall survival (OS), defined as the time from date of first dose of study treatment to date of death
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
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.
- 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.
Key Exclusion Criteria:
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.
- Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 30 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).
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04916002
Contacts
| Contact: Clinical Trial Administrator | 844-734-6643 | clinicaltrials@regeneron.com |
Locations
Show 17 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04916002 |
| Other Study ID Numbers: |
CMP-001-009 2022-501683-18-00 ( Registry Identifier: EUCT Number ) |
| First Posted: | June 7, 2021 Key Record Dates |
| Last Update Posted: | April 4, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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 |
| URL: | https://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Regeneron Pharmaceuticals:
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vidutolimod Metastatic Cancer Advanced Cancer MCC |
CSCC BCC TNBC NSCLC |
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell Carcinoma Triple Negative Breast Neoplasms Neoplasm Metastasis Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Neoplasms, Basal Cell |
Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Cemiplimab Antineoplastic Agents, Immunological Antineoplastic Agents |