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Checkpoint Inhibitor

Vidutolimod + Cemiplimab for Advanced Cancer

Phase 2
Waitlist Available
Research Sponsored by Checkmate Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening
Histopathologically-confirmed diagnosis of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights

Study Summary

This trial is studying CMP-001 given by injection into the tumor in combination with an intravenous PD-1-blocking antibody to see how well it works in treating patients with certain types of advanced or metastatic cancer.

Who is the study for?
Adults with advanced or metastatic cancer, including various carcinomas and breast cancer, who have measurable disease and are in good physical condition (ECOG 0-1). They must have proper organ function. Excluded are those recently receiving radiation therapy or with active autoimmune diseases, severe medical conditions, recent high-dose steroids use, other progressing cancers within 3 years, untreated brain metastases, or a history of severe immune-mediated reactions to PD-1 inhibitors.Check my eligibility
What is being tested?
The trial is testing the combination of vidutolimod and cemiplimab for effectiveness against advanced cancers. It aims to determine how patients' cancers respond to this treatment combo and assess its safety over a period of up to two years with follow-ups every three months after treatment ends.See study design
What are the potential side effects?
Potential side effects may include typical immune-related adverse events such as inflammation in different body parts due to an overactive immune response. Other common side effects could involve fatigue, skin reactions at the injection site for vidutolimod, flu-like symptoms such as fever or chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer diagnosis was confirmed through a tissue examination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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,TNBC or OPSCC
Secondary outcome measures
Efficacy of vidutolimod in combination with cemiplimab in the study participants
Safety and tolerability of vidutolimod administered by IT injection in combination with cemiplimab in the study participants

Trial Design

9Treatment groups
Experimental Treatment
Group I: Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)Experimental Treatment2 Interventions
Participants 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.
Group II: Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F)Experimental Treatment2 Interventions
Participants 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.
Group III: Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E)Experimental Treatment2 Interventions
Participants 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
Group IV: Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1)Experimental Treatment2 Interventions
Participants 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.
Group V: Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D)Experimental Treatment2 Interventions
Participants 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.
Group VI: Vidutolimod and cemiplimab for TNBC (C2)Experimental Treatment2 Interventions
Participants 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.
Group VII: Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1)Experimental Treatment2 Interventions
Participants 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.
Group VIII: Vidutolimod and cemiplimab for MCC (B2)Experimental Treatment2 Interventions
Participants 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.
Group IX: Vidutolimod and cemiplimab for CSCC (A2)Experimental Treatment2 Interventions
Participants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cemiplimab
2016
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

Checkmate PharmaceuticalsLead Sponsor
10 Previous Clinical Trials
474 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
617 Previous Clinical Trials
379,980 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
260 Previous Clinical Trials
250,817 Total Patients Enrolled

Media Library

Cemiplimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04916002 — Phase 2
Basal Cell Carcinoma Research Study Groups: Vidutolimod and cemiplimab for TNBC (C2), Vidutolimod and cemiplimab for recurrent/metastatic Oropharynx Squamous Cell Carcinoma (OPSCC) (F), Vidutolimod and cemiplimab for non-small cell lung cancer (NSCLC) (E), Vidutolimod and cemiplimab for cutaneous squamous cell carcinoma (CSCC) (A1), Vidutolimod and cemiplimab for CSCC (A2), Vidutolimod and cemiplimab for basal cell carcinoma (BCC) (D), Vidutolimod and cemiplimab for Merkel cell carcinoma (MCC) (B1), Vidutolimod and cemiplimab for MCC (B2), Vidutolimod and cemiplimab for triple negative breast cancer (TNBC) (C1)
Basal Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04916002 — Phase 2
Cemiplimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04916002 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are a part of this experiment?

"In order to complete this study, the research team requires 279 patients that fulfill the set inclusion criteria. Those eligible to participate can do so at University of Pittsburgh Medical Center or University of Alabama."

Answered by AI

Is this study widely available or taking place in only a few specific locations?

"University of Pittsburgh Medical Center, University of Alabama in Birmingham, VA Maryland Health Care System in Baltimore are some examples of the 14 hospitals participating in this study."

Answered by AI

Are people still being enrolled in this experiment?

"As noted on clinicaltrials.gov, this study is currently recruiting patients. The trial was originally posted on December 15th 2021 and was last edited on August 18th 2022."

Answered by AI

Has CMP-001 received official sanctioning from the FDA?

"CMP-001 has received a score of 2. This is because, although there is some data affirming the safety of this medication, there are no studies which support its efficacy."

Answered by AI

What is the primary reason that people take CMP-001?

"CMP-001 is a medication that is used to treat alk gene mutation. It can also be utilized as part of the treatment plan for patients with advance directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Is this research on CMP-001 the first of its kind?

"CMP-001 was first studied a decade ago, at City of Hope. Since then, there have been 8 completed clinical trials and 59 more that are actively recruiting patients as we speak. A significant portion of these ongoing studies are based in Pittsburgh, Pennsylvania."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04916002.
~131 spots leftby Jul 2027
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