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Sitravatinib Malate

Clinical trials are studying Sitravatinib Malate in people with advanced non-squamous non-small cell lung cancer and metastatic uveal melanoma. These studies look at how well it works, with a focus on survival and tumor response, and also compare it with other treatments. The trials include adults with disease that has progressed after earlier therapy.

Table of contents

Clinical trials overview

Two interventional studies of Sitravatinib Malate were listed in the source data, and both are completed.[1][2] One was a large Phase 3 trial in lung cancer, and the other was a smaller Phase 2 study in uveal melanoma.[1][2]

Phase 3 study in advanced non-squamous non-small cell lung cancer

The Phase 3 trial, NCT03906071, studied patients with advanced non-squamous non-small cell lung cancer whose disease had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.[1] This study compared sitravatinib and nivolumab against docetaxel, which means it tested one treatment approach against another standard cancer drug.[1]

The trial enrolled 464 patients and was designed to compare overall survival between the two treatment groups.[1] Overall survival means the length of time patients live after starting treatment.[1]

Phase 2 study in metastatic uveal melanoma

The Phase 2 trial, NCT05542342, studied patients with metastatic uveal melanoma with liver metastases.[2] It was an open-label study, which means both the researchers and the patients knew which treatment was being given.[2] The study tested Sitravatinib Malate in combination with Tislelizumab and included patients with biopsiable disease at first line or after failure of first-line systemic therapy with Tebentafusp, or after liver-directed therapy.[2]

This trial enrolled 16 patients and looked at preliminary efficacy, meaning early signs of benefit from the treatment combination.[2]

Main trial endpoints

The lung cancer study used overall survival (OS) as its primary outcome.[1] The melanoma study used objective response rate (ORR) according to RECIST 1.1 criteria as its primary outcome.[2] Objective response rate shows how many patients had tumors shrink or disappear, and RECIST 1.1 is a standard way to measure that on scans.[2]

Who the trials were designed for

These studies focused on adults with advanced cancer after earlier treatment had not worked well enough.[1][2] In the lung cancer study, patients had disease progression after platinum-based chemotherapy and checkpoint inhibitor therapy.[1] In the melanoma study, patients had metastatic uveal melanoma with liver metastases and needed tissue that could be biopsied.[2]

Because both trials are completed, the source data describe the study design and goals, but not active enrollment.[1][2]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT03906071 Phase 3 Advanced non-squamous non-small cell lung cancer Completed 464 Overall survival
NCT05542342 Phase 2 Uveal melanoma with liver metastases Completed 16 Objective response rate

FAQ

  • What conditions are being studied in trials of Sitravatinib Malate? The trials listed study advanced non-squamous non-small cell lung cancer and metastatic uveal melanoma with liver metastases. These are both advanced cancers that have already needed previous treatment.
  • Who can take part in these trials? One trial included patients whose lung cancer progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. The other trial included patients with metastatic uveal melanoma with liver metastases and biopsiable disease, either at first line or after earlier treatment failure.
  • What phases are the Sitravatinib Malate trials? One study is Phase 3 and the other is Phase 2. Phase 3 usually compares treatments in a larger group, while Phase 2 looks more closely at early signs of benefit.
  • What are the main goals of these trials? The lung cancer trial studied overall survival, which means how long patients live after treatment. The melanoma trial studied objective response rate, which means how many tumors shrink or disappear by imaging rules.
  • Are these trials still recruiting? No. Both trials listed here are completed. That means the study treatment and data collection have already finished.

Ongoing Clinical Trials on Sitravatinib Malate

  • Study on the Effects of Sitravatinib and Tislelizumab for Patients with Metastatic Uveal Melanoma and Liver Metastases

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Sitravatinib and Nivolumab vs. Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Chemotherapy and Checkpoint Inhibitor Therapy

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Italy The Netherlands Spain

Glossary

  • Advanced cancer: Cancer that has spread or grown enough to need more complex treatment.
  • Non-squamous non-small cell lung cancer: A common type of lung cancer that is not the squamous subtype.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Uveal melanoma: A rare melanoma that starts in the eye.
  • Liver metastases: Cancer spread to the liver.
  • Checkpoint inhibitor therapy: A type of cancer treatment that helps the immune system attack cancer cells.
  • Overall survival (OS): A measure of how long patients live after starting treatment.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • RECIST 1.1: A standard set of rules used to measure whether tumors have responded to treatment.
  • Biopsiable disease: Tumor tissue that can be sampled with a biopsy, which is a small tissue test.

References