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6d
International real-world study of combination immunotherapy sequences in metastatic melanoma. (PubMed, J Immunother Cancer)
Our findings indicate that rela/nivo may remain active following anti-PD-1 or ipi/nivo therapy. Additionally, our results suggest that sequencing ipi/nivo before rela/nivo may yield better outcomes than starting with rela/nivo. Patients who respond to the first combination regimen appear to derive greater benefit from the second. Further efforts are needed to optimize sequencing strategies in advanced melanoma, and future studies should consider the impact of prior treatment outcomes.
Retrospective data • Journal • Real-world evidence
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LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
11d
Lead-in therapy targeting PD1 and/or LAG3 imposes distinct immune phenotypes in first-line treatment of metastatic melanoma. (PubMed, medRxiv)
The analyses of component agents afforded by this novel lead-in trial has identified differential clinical and immunological modulation of anti-PD1 and anti-LAG3 in comparison to the combination therapy. Lead-in monotherapy with nivolumab or relatlimab reduces efficacy to the comboMPRbx serves as an early surrogate marker of response and long-term PFS Relatlimab lead-in led to CD8 + T cell:Treg clustering in the TME and poor PFS Combo therapy non-responders had decreased CD14 + CD16 - HLA-DR low CD33 dim monocytes.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD33 (CD33 Molecule) • CD14 (CD14 Molecule) • FOXP3 (Forkhead Box P3)
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Opdivo (nivolumab) • relatlimab (BMS-986016)
15d
Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation) (clinicaltrials.gov)
P2, N=531, Not yet recruiting, Melanoma Institute Australia | N=297 --> 531 | Initiation date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2027 --> Dec 2027
Enrollment change • Trial initiation date • Trial primary completion date • IO biomarker
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
22d
Trial completion • Real-world evidence
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Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
25d
Endoscopic Ultrasound With Fine Needle Biopsy Confirming a Diagnosis of Immune Checkpoint Inhibitor-Related Type 3 Autoimmune Pancreatitis. (PubMed, Case Rep Gastrointest Med)
A 71-year-old male with metastatic mucosal melanoma of the urethra was treated with immune checkpoint inhibitor (ICI) therapy (nivolumab/relatlimab) and developed vague epigastric discomfort...He was treated successfully with prednisone...Type 3 AIP typically presents along with other immune-related adverse events. Endoscopic ultrasound with FNB contributed to diagnostic certainty in this case and changed our patient's management, allowing for appropriate treatment of his immune-related adverse event.
Journal • Checkpoint inhibition
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Opdivo (nivolumab) • prednisone • relatlimab (BMS-986016)
1m
SIMONE: Saci Nivo Rela for TNBC (clinicaltrials.gov)
P1/2, N=60, Recruiting, Yale University | Not yet recruiting --> Recruiting
Enrollment open
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Opdivo (nivolumab) • Trodelvy (sacituzumab govitecan-hziy) • relatlimab (BMS-986016)
1m
PERIO-01: Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (clinicaltrials.gov)
P1, N=67, Terminated, TriSalus Life Sciences, Inc. | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.
Trial termination • Checkpoint inhibition
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Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • nelitolimod (SD-101) • relatlimab (BMS-986016)
2ms
Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. (PubMed, Nat Med)
The absence of macroscopic tumor and reduced peripheral LAG-3+ T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma. ClinicalTrials.gov identifier: NCT05002569 .
P3 data • Journal
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LAG3 (Lymphocyte Activating 3)
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Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
2ms
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor (clinicaltrials.gov)
P2, N=42, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
Trial completion date • Trial primary completion date • Mismatch repair • dMMR
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Opdivo (nivolumab) • relatlimab (BMS-986016)
2ms
NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov)
P2, N=6452, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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MSI (Microsatellite instability) • CD4 (CD4 Molecule)
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Opdivo (nivolumab) • Herceptin (trastuzumab) • Mekinist (trametinib) • Xalkori (crizotinib) • Tagrisso (osimertinib) • Gilotrif (afatinib) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • sunitinib • Kadcyla (ado-trastuzumab emtansine) • Balversa (erdafitinib) • Mektovi (binimetinib) • adavosertib (AZD1775) • Truqap (capivasertib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • sapanisertib (CB-228) • ipatasertib (RG7440) • taselisib (GDC-0032) • omipalisib (GSK2126458) • ulixertinib (BVD-523) • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Fakzynja (defactinib) • GSK2636771 • Paletan (pertuzumab biosimilar) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Pertuvia (pertuzumab biosimilar)
2ms
NESCIO: Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer (clinicaltrials.gov)
P2, N=69, Active, not recruiting, The Netherlands Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Apr 2025
Enrollment closed • Trial primary completion date • IO biomarker
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3)
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Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)