biostudies-literatureGandhi SBristol-Myers SquibbCelgeneRegeneronNCATS NIH HHSGenentechTakedaRoswell Park Alliance FoundationNIDDK NIH HHSNIH/NCIBoehringer IngelheimNCI NIH HHSNIHe010058https://www.ebi.ac.uk/biostudies/studies/S-EPMC11575314biostudies-literatureUnknown12(11)<h4>Background</h4>Higher cytotoxic T lymphocyte (CTL) numbers in the tumor microenvironment (TME) predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and positive long-term outcomes in triple-negative breast cancer (TNBC). pCR to NAC is achieved only in 30-40% of patients. The combination of NAC with pembrolizumab increases the pCR rate but at the cost of immune-related adverse events (irAEs). Based on these considerations, we tested if systemic infusion of the chemokine modulatory regimen (CKM; selective toll-like receptor 3 (TLR3) agonist rintatolimod, interferon (IFN)-α2b, and cyclooxygenase-2 (COX-2) inhibitor celecoxib) regimen can be safely combined with NAC to enhance intratumoral CTL numbers and NAC effectiveness.<h4>Methods</h4>Phase I study NCT04081389 eJournal for immunotherapy of cancerSystemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer.PMC11575314U24 CA224319N/AUL1 TR004419CA2243191P01CA234212UL1 TR001412CA263705K08 CA279766R03 TR004607KL2 TR0014132P30A016056-42P01 CA234212P30 CA196521R33 CA263705R03TR004607-011K08CA279766-01A1CA196521DK124165UL1TR004419U01 DK124165Attwood KMiller JRoudko VGnjatic SFitzpatrick VDe Souza ITakabe KO'Connor TKumar PWang JOzbey SCappuccino HLevine EGIoannou GOpyrchal MGandhi SKokolus KMCortes Gomez ESlomba RTJanes CYoung JKalinski PKalathil SEdge SfalseSystemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer.<h4>Background</h4>Higher cytotoxic T lymphocyte (CTL) numbers in the tumor microenvironment (TME) predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and positive long-term outcomes in triple-negative breast cancer (TNBC). pCR to NAC is achieved only in 30-40% of patients. The combination of NAC with pembrolizumab increases the pCR rate but at the cost of immune-related adverse events (irAEs). Based on these considerations, we tested if systemic infusion of the chemokine modulatory regimen (CKM; selective toll-like receptor 3 (TLR3) agonist rintatolimod, interferon (IFN)-α2b, and cyclooxygenase-2 (COX-2) inhibitor celecoxib) regimen can be safely combined with NAC to enhance intratumoral CTL numbers and NAC effectiveness.<h4>Methods</h4>Phase I study NCT04081389 e2024-01-01T00:00:00Z2024 Nov2026-07-15T09:42:02.117Z2025-04-04T11:43:18.874ZS-EPMC115753143954265510.1136/jitc-2024-010058