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Phase II LEAP-004 S...
Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination.
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- Arance, Ana (författare)
- Hospital Clínic of Barcelona,Edith Cowan University
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de la Cruz-Merino, Luis (författare)
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- Petrella, Teresa M (författare)
- Sunnybrook Health Sciences Centre
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- Jamal, Rahima (författare)
- University Of Montreal Health Center (CRCHUM)
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- Ny, Lars, 1967 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrenska University Hospital
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- Carneiro, Ana (författare)
- Lund University,Lunds universitet,Lunds Melanomstudiegrupp,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Melanom,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lund Melanoma Study Group,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Melanoma,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
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Berrocal, Alfonso (författare)
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- Márquez-Rodas, Ivan (författare)
- Hospital Gregorio Maranon
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- Spreafico, Anna (författare)
- Princess Margaret Hospital University of Toronto
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- Atkinson, Victoria (författare)
- University of Queensland
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- Costa Svedman, Fernanda (författare)
- Karolinska University Hospital
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- Mant, Andrew (författare)
- Monash University
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Khattak, Muhammad A (författare)
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- Mihalcioiu, Catalin (författare)
- Royal Victoria Hospital, Montreal
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Jang, Sekwon (författare)
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Cowey, C Lance (författare)
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Smith, Alan D (författare)
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- Hawk, Natalyn (författare)
- Eisai Inc.
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- Chen, Ke (författare)
- Merck Sharp And Dohme Corp., US
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- Diede, Scott J (författare)
- Merck Sharp And Dohme Corp., US
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- Krepler, Clemens (författare)
- Merck Sharp And Dohme Corp., US
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- Long, Georgina V (författare)
- University of Sydney
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(creator_code:org_t)
- 2023
- 2023
- Engelska.
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Ingår i: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 1527-7755. ; 41:1, s. 75-85
- Relaterad länk:
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http://dx.doi.org/10...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
Stäng
- Effective treatments are needed for melanoma that progresses on inhibitors of programmed cell death protein-1 (PD-1) or its ligand (PD-L1). We conducted the phase II LEAP-004 study to evaluate the combination of the multikinase inhibitor lenvatinib and the PD-1 inhibitor pembrolizumab in this population (ClinicalTrials.gov identifier: NCT03776136).Eligible patients with unresectable stage III-IV melanoma with confirmed progressive disease (PD) within 12 weeks of the last dose of a PD-1/L1 inhibitor given alone or with other therapies, including cytotoxic T-cell lymphocyte-associated antigen 4 (CTLA-4) inhibitors, received lenvatinib 20 mg orally once daily plus ≤ 35 doses of pembrolizumab 200 mg intravenously once every 3 weeks until PD or unacceptable toxicity. The primary end point was objective response rate (ORR) per RECIST, version 1.1, by independent central review.A total of 103 patients were enrolled and treated. The median study follow-up was 15.3 months. ORR in the total population was 21.4% (95% CI, 13.9 to 30.5), with three (2.9%) complete responses and 19 (18.4%) partial responses. The median duration of response was 8.3 months (range, 3.2-15.9+). ORR was 33.3% in the 30 patients with PD on prior anti-PD-1 plus anti-CTLA-4 therapy. The median progression-free survival and overall survival in the total population were 4.2 months (95% CI, 3.8 to 7.1) and 14.0 months (95% CI, 10.8 to not reached), respectively. Grade 3-5 treatment-related adverse events occurred in 47 (45.6%) patients, most commonly hypertension (21.4%); one patient died from a treatment-related event (decreased platelet count).Lenvatinib plus pembrolizumab provides clinically meaningful, durable responses in patients with advanced melanoma with confirmed PD on prior PD-1/L1 inhibitor-based therapy, including those with PD on anti-PD-1 plus anti-CTLA-4 therapy. The safety profile was as expected. These data support lenvatinib plus pembrolizumab as a potential regimen for this population of high unmet need.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- Humans
- Immune Checkpoint Inhibitors
- therapeutic use
- B7-H1 Antigen
- Melanoma
- drug therapy
- Apoptosis Regulatory Proteins
- therapeutic use
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Arance, Ana
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de la Cruz-Merin ...
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Petrella, Teresa ...
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Jamal, Rahima
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Ny, Lars, 1967
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Carneiro, Ana
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visa fler...
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Berrocal, Alfons ...
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Márquez-Rodas, I ...
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Spreafico, Anna
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Atkinson, Victor ...
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Costa Svedman, F ...
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Mant, Andrew
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Khattak, Muhamma ...
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Mihalcioiu, Cata ...
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Jang, Sekwon
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Cowey, C Lance
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Smith, Alan D
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Hawk, Natalyn
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Chen, Ke
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Diede, Scott J
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Krepler, Clemens
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Long, Georgina V
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
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Journal of clini ...
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Journal of Clini ...
- Av lärosätet
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Göteborgs universitet
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Lunds universitet