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Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma Vrije Universiteit Brussel

Hussein A Tawbi, Dirk Schadendorf, Evan J Lipson, Paolo A Ascierto, Luis Matamala, Erika Castillo Gutiérrez, Piotr Rutkowski, Christopher D Lao

BACKGROUND: Lymphocyte-activation gene 3 (LAG-3) and programmed death 1 (PD-1) are distinct inhibitory immune checkpoints that contribute to T-cell exhaustion. The combination of relatlimab, a LAG-3-blocking antibody, and nivolumab, a PD-1-blocking antibody, has been shown to be safe and to have antitumor activity in patients with previously treated melanoma, but the safety and activity in patients with previously untreated melanoma need ...

Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma KU Leuven

Patrick Schöffski
PURPOSE: In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND METHODS: Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed ...

Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival KU Leuven

Eric Van Cutsem
BACKGROUND: Matrix metalloproteinase-9 (MMP9) selectively cleaves extracellular matrix proteins contributing to tumor growth and an immunosuppressive microenvironment. This study evaluated andecaliximab (ADX), an inhibitor of MMP9, in combination with nivolumab (NIVO), for the treatment of advanced gastric cancer. METHODS: Phase 2, open-label, randomized multicenter study evaluating the efficacy, safety, and pharmacodynamics of ADX+NIVO versus ...

A randomized, multicentric phase II study of preoperative nivolumab plus relatlimab or nivolumab in patients with resectable non-small cell lung cancer (NEOpredict-Lung) Hasselt University

M. H. H. Schuler, Kristof CUPPENS, T. Ploenes, M. Vanbockrijck, M. Wiesweg, K. Darwiche, A. Schramm, Brigitte MAES, B. Hegedus, H-U. Schildhaus, et al.
Background: Preoperative immune checkpoint inhibitor therapy (PICIT) is a promising approach in curative treatment of non-small-cell lung cancer (NSCLC). This study explores the feasibility and efficacy of targeting PD-1 and LAG-3 prior to resection.

Real-World Effectiveness, Safety, and Health-Related Quality of Life in Patients Receiving Adjuvant Nivolumab for Melanoma in Belgium and Luxembourg Vrije Universiteit Brussel

Anne Rogiers, Laurence Willemot, Laura McDonald, Hilde Van Campenhout, Guy Berchem, Céline Jacobs, Nathalie Blockx, Andrée Rorive, Bart Neyns

BACKGROUND: Nivolumab, an anti-programmed cell death 1 immuno-oncology therapy, is approved as an adjuvant treatment for patients with completely resected stage III or stage IV melanoma. PRESERV MEL (Prospective and REtrospective Study of nivolumab thERapy in adjuVant MELanoma) is a real-world observational study evaluating the effectiveness and safety of adjuvant nivolumab in patients with completely resected stage III or stage IV melanoma ...

Low-Dose Nivolumab with or without Ipilimumab as Adjuvant Therapy Following the Resection of Melanoma Metastases: A Sequential Dual Cohort Phase II Clinical Trial Vrije Universiteit Brussel

Soizic Garaud, Gil Awada, Valerie Vandersleyen, Alexandre de Wind, Paulus Kristanto, Teofila Seremet, Karen Willard-Gallo
Background: Optimal dosing and duration of adjuvant treatment with PD-1 and CTLA-4 immune checkpoint inhibitors have not been established. Prior to their regulatory approval we investigated a low-dose regimen of nivolumab with or without ipilimumab in a sequential dual- cohort phase II clinical trial. Methods: Following the complete resection of melanoma metastases, patients were treated with a single fixed dose of ipilimumab (50 mg) plus 4 ...

Efficacy of a Flat Low Dose of Nivolumab in Advanced Cancer Vrije Universiteit Brussel

Sofie Joris, Christel Fontaine, Lore Decoster, Jacques Vanderauwera, Kris Thielemans, Wim Waelput, Jacques De Grève

BACKGROUND/AIM: Immunotherapy with PD-1/PDL1 blocking monoclonal antibodies has improved survival compared to the standard-of-care chemotherapy for several malignancies at different stages of these malignancies. Due to several reasons, many cancer patients in medical need have no access to these drugs. In this study, we aimed to investigate whether a low dose of nivolumab could also lead to a therapeutic response.

PATIENTS AND METHODS: ...

Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037 Vrije Universiteit Brussel

James Larkin, David Minor, Sandra P D'Angelo, Bart Neyns, Michael Smylie, Wilson H Miller, Ralf Gutzmer, Gerald Linette, Bartosz Chmielowski, Christopher D Lao, et al.

Purpose Until recently, limited options existed for patients with advanced melanoma who experienced disease progression while receiving treatment with ipilimumab. Here, we report the coprimary overall survival (OS) end point of CheckMate 037, which has previously shown that nivolumab resulted in more patients achieving an objective response compared with chemotherapy regimens in ipilimumab-refractory patients with advanced melanoma. Patients ...