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
- Conditions
- Advanced or Metastatic CancerMerkel Cell Carcinoma (MCC)Cutaneous Squamous Cell Carcinoma (CSCC)Basal Cell Carcinoma (BCC)Triple Negative Breast Cancer (TNBC)Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.0Level: LLTClassification code: 10048683Term: Advanced cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507344-36-01
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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, Other protocol defined inclusion criteria apply
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., Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment., NOTE: Other protocol defined Inclusion/Exclusion Criteria apply, Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors)., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): ORR, defined as the proportion of subjects 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) by investigator assessment;Main Objective: To determine confirmed objective response rate (ORR) with vidutolimod in combination with cemiplimab per RECIST 1.1 by investigator;Secondary Objective: To evaluate the safety and tolerability of vidutolimod administered by intratumoral (IT) injection in combination with cemiplimab, To evaluate the efficacy of vidutolimod in combination with cemiplimab
- Secondary Outcome Measures
Name Time Method Secondary end point(s):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);Secondary end point(s):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, per investigator;Secondary end point(s):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;Secondary end point(s):Response in injected and noninjected target lesions per RECIST v1.1;Secondary end point(s):Overall survival (OS), defined as the time from date of first dose of study treatment to date of death