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

Conditions

Advanced or Metastatic Cancer Merkel Cell Carcinoma (MCC) Cutaneous Squamous Cell Carcinoma (CSCC) Basal Cell Carcinoma (BCC) Triple Negative Breast Cancer (TNBC) Non-Small Cell Lung Cancer (NSCLC)

Brief summary

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

Detailed description

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), 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, 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, Response in injected and noninjected target lesions per RECIST v1.1, Overall survival (OS), defined as the time from date of first dose of study treatment to date of death

Related papers

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Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGVidutolimod

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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), 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, 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, Response in injected and noninjected target lesions per RECIST v1.1, Overall survival (OS), defined as the time from date of first dose of study treatment to date of death	—

Measure

Time frame

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), 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, 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, Response in injected and noninjected target lesions per RECIST v1.1, Overall survival (OS), defined as the time from date of first dose of study treatment to date of death

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Countries

France

Outcome results

None listed