Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022
A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART, SWOG S1609).
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. 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 100 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
100 citing papers in PubMed, 2 syntheses or guidelines pooled it, 120 citations in OpenAlex.
- Treatment-Related and Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitor-Based Combination Therapies for Breast Cancer: A Systematic Review and Meta-Analysis.Thoracic cancer · 2026Pooled it
- Breast conservation versus mastectomy for metaplastic breast cancer: A systematic review and meta-analysis.Asia-Pacific journal of clinical oncology · 2025Pooled it
- Trial
- Multicenter phase II trial of ipilimumab and nivolumab in metastatic or unresectable perivascular epithelioid cell tumor (PEComa): a substudy ofJournal for immunotherapy of cancer · 2025Trial
- A phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: durable responses and delayed pseudoprogression in small cell carcinoma of the ovary, hypercalcemic type cohort.Cancer communications (London, England) · 2025Trial
- Phase II basket trial of Dual Anti-CTLA-4 and anti-PD-1 blockade in Rare Tumors (DART) SWOG S1609: pancreatic neuroendocrine neoplasm (PNEN) cohort.Journal for immunotherapy of cancer · 2025Trial
- Nivolumab plus low-dose ipilimumab in hypermutated HER2-negative metastatic breast cancer: a phase II trial (NIMBUS).Nature communications · 2025Trial
- A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors SWOG S1609: Vulvar Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- SWOG/NCI Phase II Dual Anti-CTLA-4/PD-1 Blockade in Rare Tumors: Nonepithelial Ovarian Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Neoadjuvant nivolumab or nivolumab plus ipilimumab in early-stage triple-negative breast cancer: a phase 2 adaptive trial.Nature medicine · 2024Trial
- Phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: the desmoid tumors.Journal for immunotherapy of cancer · 2024Trial
- Phase II basket trial of Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (DART) SWOG S1609: adrenocortical carcinoma cohort.Journal for immunotherapy of cancer · 2024Trial
- A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 47) in Patients with Gestational Trophoblastic Neoplasia.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Neoadjuvant Chemo-Immunotherapy Yields Survival Comparable to Upfront Surgery in Metaplastic Breast Cancer: A National Cancer Database Analysis.Annals of surgical oncology · 2026Article
- The weight of the enemy: Tumor burden as a tumor-agnostic prognostic marker and the limits of immunotherapy.Cancer · 2026Article
- Harnessing immunity against breast cancer: from checkpoints to cell therapies.Journal of translational medicine · 2026Review
- Advances in Immunotherapy for Breast Cancer: Up-to-date Strategies of Immune Checkpoint Inhibitors and Therapeutic Vaccines.Current treatment options in oncology · 2026Review
- Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multicenter Basket Trial Analysis (NCI/SWOG S1609).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Bispecific Antibodies in Breast Cancer Immunotherapy: Mechanisms, Advances, and Translational Challenges.Targeted oncology · 2026Review
- Advances in Breast Cancer Research: Immunological, Pathological, and Pharmacological Perspectives for Improving Patient Outcomes.International journal of molecular sciences · 2026Review
40 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 20 institutions in 2 countries.
Funding
Abstract
purposeMetaplastic breast cancer (MpBC) is a rare aggressive subtype that responds poorly to cytotoxics. Median survival is approximately 8 months for metastatic disease. We report results for advanced MpBC treated with ipilimumab + nivolumab, a cohort of S1609 for rare cancers (DART: NCT02834013). PATIENTS AND
methodsProspective, open-label, multicenter phase II (two-stage) trial of ipilimumab (1 mg/kg i.v. every 6 weeks) plus nivolumab (240 mg i.v. every 2 weeks) for advanced MpBC. Primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.
resultsOverall, 17 evaluable patients enrolled. Median age was 60 years (26-85); median number of prior therapy lines was 2 (0-5). ORR was 18%; 3 of 17 patients achieved objective responses (1 complete, 2 partial responses; 2 spindle cell, 1 chondromyxoid histology), which are ongoing at 28+, 33+, and 34+ months, respectively. Median PFS and OS were 2 and 12 months, respectively. Altogether, 11 patients (65%) experienced adverse events (AE), including one grade 5 AE. Eight patients (47%) developed an immune-related AE (irAE), with adrenal insufficiency observed in all 3 responders. Responses occurred in tumors with low tumor mutational burden, low PD-L1, and absent tumor-infiltrating lymphocytes.
conclusionsThe ipilimumab and nivolumab combination showed no new safety signals and met its primary endpoint with 18% ORR in advanced, chemotherapy-refractory MpBC. All responses are ongoing at >2 to almost 3 years later. The effect of ipilimumab and nivolumab was associated with exceptional responses in a subset of patients versus no activity. This combination warrants further investigation in MpBC, with special attention to understanding mechanism of action, and carefully designed to weigh against the significant risks of irAEs.
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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.