Trial reportMolecular cancer2025
Sitravatinib plus tislelizumab in locally recurrent or metastatic triple-negative breast cancer: a multi-cohort, single-arm, phase II clinical trial (SPARK Trial).
Trial report in Molecular cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04734262 (A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)
Who cites it
1 citing paper in PubMed.
- Current and future therapies for triple-negative breast cancer.Journal of hematology & oncology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
Abstract
backgroundWhile immunotherapy-chemotherapy combinations are approved for programmed death-ligand 1 (PD-L1)-positive advanced triple-negative breast cancer (TNBC), the therapeutic potential of sitravatinib-enhanced immunotherapy remains unexplored.
methodsThis multi-cohort, single-arm study enrolled 67 patients with locally recurrent/metastatic TNBC. Cohorts A (n = 21) and B (n = 40) received sitravatinib 70 mg or 100 mg once daily plus tislelizumab, with 38/67 participants having ≥ 1 prior systemic therapy. The primary endpoint was confirmed objective response rate (ORR); secondary endpoints included median progression-free survival (PFS) and safety. Multi-omics analyses including single-cell sequencing and genomic profiling were performed on tumor samples to identify biomarkers linked to treatment response.
resultsConfirmed ORR was 38.1% (8/21) in Cohort A and 50.0% (20/40) in Cohort B. Median PFS was 8.2 months (Cohort A) and 5.4 months (Cohort B). Notably, 95.3% (41/43) of previously treated patients had PD-L1 combined positive score (CPS) < 10. No grade 4/5 treatment-related adverse events occurred. Biomarker analysis revealed Th17 cell infiltration and TYRO3/AXL/MERTK (TAM) pathway activation correlated with response, while FAM47C mutations and LSM1+ cancer-associated fibroblasts were enriched in non-responders. Post-treatment TP53 mutation clearance and increased CD8+ T cell proportions predicted improved outcomes.
conclusionsSitravatinib plus tislelizumab demonstrates promising efficacy and safety as a chemo-free regimen for metastatic TNBC, including PD-L1-negative tumors. Biomarkers such as Th17 cell infiltration, TAM signaling, and TP53 mutation dynamics may guide patient selection. These findings support further validation of this combination in PD-L1-negative TNBC and highlight the role of multi-omics in optimizing immunotherapy strategies.
trial registrationClinicalTrials.gov, NCT04734262.
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