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Vidutolimod

Clinical trials are investigating Vidutolimod in adults with advanced or metastatic cancers. These studies are looking at safety and how well Vidutolimod works, often in combination with cemiplimab, in cancers such as Merkel cell carcinoma, cutaneous squamous cell carcinoma, basal cell carcinoma, triple negative breast cancer, and non-small cell lung cancer.

Table of Contents

Trial overview

The available trial data show one interventional study of Vidutolimod in adults with advanced or metastatic cancer.[1]

This study is a Phase 2 trial, which means it is designed to learn more about whether the treatment works and to keep collecting safety information.[1]

The study is marked as completed and included 200 participants.[1]

Who can participate

The trial focused on adult participants with advanced cancer or metastatic cancer.[1]

The cancers listed in the study were Merkel cell carcinoma (MCC), cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), triple negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC).[1]

These are different cancer types, but they all fit the study’s broad group of advanced or metastatic disease.[1]

What is being measured

The main endpoint, or main result the researchers wanted to measure, was objective response rate (ORR).[1]

ORR means the share of patients who had a confirmed tumor response, either a complete response (CR) or a partial response (PR), based on RECIST v1.1 rules and investigator assessment.[1]

RECIST v1.1 is a standard system used in cancer trials to judge whether tumors have shrunk, stayed stable, or grown.[1]

Trial details

In this study, Vidutolimod was tested together with cemiplimab, which was listed as LIBTAYO in the source data.[1]

The source data list two ways Vidutolimod was given: subcutaneous use and intratumoral use.[1]

Subcutaneous means under the skin, and intratumoral means directly into the tumor.[1]

The trial title says the study was designed to find out if the combination was safe and if it worked in adults with advanced cancer or metastatic cancer.[1]

How to read the results

Because the study is completed, the main value of the trial is the information it provides about treatment response and safety in the studied cancer groups.[1]

Patient-focused trial results like ORR help show whether a cancer treatment can shrink tumors in real-world study conditions.[1]

Even when a study includes several cancer types, the results may still be reported together if the trial was designed that way.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04916002 Phase 2 Advanced or metastatic cancer, including MCC, CSCC, BCC, TNBC, and NSCLC Completed 200

FAQ

  • What is being studied in Vidutolimod clinical trials? These trials are studying Vidutolimod, often together with cemiplimab, to see if the treatment is safe and if it helps shrink tumors. The main focus is how many patients have a confirmed cancer response.
  • Who can take part in these trials? The trial data describe adult participants with advanced cancer or metastatic cancer. The cancers studied include Merkel cell carcinoma, cutaneous squamous cell carcinoma, basal cell carcinoma, triple negative breast cancer, and non-small cell lung cancer.
  • What phase is the Vidutolimod trial? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment works and continue to collect safety information.
  • What does the trial measure as the main result? The main result is objective response rate, or ORR. This means the study checks how many people have a complete response or partial response based on standard cancer scan rules.
  • Is the Vidutolimod study completed? Yes. The trial listed in the source data is marked as completed. That means the study has finished collecting its planned data.

Ongoing Clinical Trials on Vidutolimod

  • Study on the Safety and Effectiveness of Vidutolimod and Cemiplimab for Adults with Advanced or Metastatic Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • Advanced cancer: Cancer that has grown beyond the original site and is harder to treat than early-stage cancer.
  • Metastatic cancer: Cancer that has spread to other parts of the body.
  • Merkel cell carcinoma (MCC): A rare and fast-growing type of skin cancer.
  • Cutaneous squamous cell carcinoma (CSCC): A common type of skin cancer that starts in the outer layer of the skin.
  • Basal cell carcinoma (BCC): A common skin cancer that usually grows slowly.
  • Triple negative breast cancer (TNBC): A type of breast cancer that does not have three common markers used to guide treatment.
  • Non-small cell lung cancer (NSCLC): The most common group of lung cancers.
  • Interventional study: A study in which participants receive a treatment or intervention planned by the researchers.
  • Phase 2: A mid-stage clinical trial that checks if a treatment works and continues to study safety.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink in a confirmed way.
  • Complete response (CR): No signs of cancer are seen after treatment.
  • Partial response (PR): The cancer has shrunk, but has not disappeared completely.

References