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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

Must not have

Had major surgeries within last 4 weeks prior to enrollment and not recovered adequately

History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had major surgery less than 4 weeks ago and haven't fully recovered.

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I stopped a PD-1 blocker treatment permanently due to a severe side effect.

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I have or had lung inflammation treated with steroids.

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I have been treated for an autoimmune disease in the last 2 years.

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I have another cancer that is growing or was treated in the last 3 years.

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I have untreated brain metastases or meningitis from cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~910

0 / 8Eligibility criteria met