In short
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.
Key points
- Clinical trials of Sitravatinib Malate are studying advanced cancer, mainly advanced non-squamous non-small cell lung cancer and metastatic uveal melanoma with liver metastases. One trial is Phase 3 and compares a Sitravatinib Malate combination with docetaxel, while the other is Phase 2 and looks at a Sitravatinib Malate combination for early signs of benefit. The lung cancer study focused on patients whose disease progressed after platinum-based chemotherapy and checkpoint inhibitor therapy. The melanoma study included patients with liver metastases and biopsiable disease, including some after prior treatment. Both trials are completed. The main outcomes were overall survival in lung cancer and objective response rate in melanoma.
Clinical trials overview
Two interventional studies of Sitravatinib Malate were listed in the source data, and both are completed. One was a large Phase 3 trial in lung cancer, and the other was a smaller Phase 2 study in uveal melanoma.
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. This study compared sitravatinib and nivolumab against docetaxel, which means it tested one treatment approach against another standard cancer drug.
The trial enrolled 464 patients and was designed to compare overall survival between the two treatment groups. Overall survival means the length of time patients live after starting treatment.
Phase 2 study in metastatic uveal melanoma
The Phase 2 trial, NCT05542342, studied patients with metastatic uveal melanoma with liver metastases. It was an open-label study, which means both the researchers and the patients knew which treatment was being given. 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.
This trial enrolled 16 patients and looked at preliminary efficacy, meaning early signs of benefit from the treatment combination.
Main trial endpoints
The lung cancer study used overall survival (OS) as its primary outcome. The melanoma study used objective response rate (ORR) according to RECIST 1.1 criteria as its primary outcome. 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.
Who the trials were designed for
These studies focused on adults with advanced cancer after earlier treatment had not worked well enough. In the lung cancer study, patients had disease progression after platinum-based chemotherapy and checkpoint inhibitor therapy. In the melanoma study, patients had metastatic uveal melanoma with liver metastases and needed tissue that could be biopsied.
Because both trials are completed, the source data describe the study design and goals, but not active enrollment.