Trial reportCancer2026
Baseline tumor burden and outcomes in patients with rare cancers treated with immunotherapy (Southwest Oncology Group trial S1609).
Trial report in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02834013 (DART), 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.
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundIt has been suggested that baseline tumor burden may correlate with immune checkpoint inhibitor (ICI) outcome for individual tumor types in which ICIs are standardly used. The authors investigated whether pretreatment tumor burden correlates with overall survival (OS), progression-free survival (PFS), and tumor regression among patients who had rare cancers treated with dual ICIs.
methodsSouthwest Oncology Group study S1609 was a phase 2, National Cancer Institute/Southwest Oncology Group basket study (>1000 sites) evaluating nivolumab plus ipilimumab in 53 cohorts of patients who had rare/ultrarare malignancies (ClinicalTrials.gov identifier NCT02834013). Overall, 722 patients were included in this secondary analysis, all of whom had measurable disease (Response Evaluation Criteria in Solid Tumors, version 1.1). Baseline tumor burden, defined as the sum of the greatest dimensions of target lesions at study registration, was analyzed based on quartiles observed in the data. The number of target lesions was also considered a secondary tumor burden measure. End points included OS and PFS.
resultsLarger baseline tumor burden correlated with shorter OS, but not PFS (multivariable analysis). Higher baseline tumor burden quartiles had only a weak negative association with any tumor regression at first scan (Fisher exact test, p = .09), and multivariable analyses further indicated that both tumor burden and any tumor regression at first posttreatment scan were independently associated with OS in multivariable analysis (comparing a baseline tumor size ≥12.9 cm vs. 1.0-4.8 cm; hazard ratio, 1.64; 95% confidence interval, 1.02-1.72; p = .032), but there was no evidence of an interaction between tumor burden and any tumor regression at the first scan (p for interaction > .65).
conclusionsLarger baseline tumor burden was associated with worse OS, but not PFS, and was not predictive of tumor regression after dual ICI therapy in a large cohort with rare cancer types.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.