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RecruitingLast updated: 9 November 2023

This study aims to learn if giving two immunotherapies together (called cemiplimab and vidutolimod) could be effective in treating certain types of advanced or metastatic cancerA 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

Clinical summary

Summary

Eligible participants will be allocated into treatment arms depending on their cancer type and prior treatment. All arms will receive treatment with both vidutolimod (intratumourally) and cemiplimab (intravenously).

The different treatment arms include:

  • People with cutaneous squamous cell carcinoma (CSCC) who have not received prior systemic therapy for their CSCC;
  • People with CSCC who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for CSCC;
  • People with merkel cell carcinoma (MCC) who have not received prior systemic therapy for MCC;
  • People with MCC who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for MCC;
  • People with triple negative breast cancer (TNBC) who have not received prior therapy with immune checkpoint inhibitors (iCPIs) for TNBC;
  • People with TNBC who have progressed while receiving a PD-1-blocking antibody or are within 12 weeks of discontinuation of treatment for TNBC;
  • People with basal cell carcinoma (BCC) who have not received prior hedgehog pathway inhibitor therapy, nor prior therapy with (iCPIs), for metastatic or locally and/or regionally advanced unresectable BCC;
  • People with advanced non-small cell lung cancer (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.

Conditions

This trial is treating patients with merkel cell carcinoma, cutaneous squamous cell carcinoma, basal cell carcinoma, triple negative breast cancer, and non-small cell lung cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Regeneron Pharmaceuticals

Scientific 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

Eligibility

Inclusion

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.
  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.

Exclusion

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. 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.
  3. History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
  4. 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.
  5. Active pneumonitis or history of noninfectious pneumonitis that required steroids.
  6. 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.
  7. Known history of immunodeficiency.
  8. Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.
  9. Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
  10. 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

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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