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Clinical Trial Finder

Search Results

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Study Purpose

The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight > 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma.Previously treated for unresectable or metastatic melanoma:
  • - Participants with NRAS mutation: - Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
  • - A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed.
Additional agents administered with CPI are permitted.
  • - To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy.
Confirmation is not required for patients who remained on treatment for >6 months.
  • - Participants with BRAFV600 mutant disease: - Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy.
  • - A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed.
Additional agents with CPI are permitted.
  • - A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
  • - Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
  • - ≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
  • - ≤ 2 weeks for small molecule therapeutics.
  • - ≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
  • - ≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
  • - ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c.
Participants participating in additional parallel investigational drug or medical device studies. All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. Other protocol-defined exclusion criteria may apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04417621
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Argentina, Australia, Belgium, France, Germany, Israel, Italy, Netherlands, Norway, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Experimental: LXH254 + LTT462

Experimental: LXH254 + trametinib

Experimental: LXH254 + ribociclib

Interventions

Drug: - LXH254

LXH254 will be supplied as tablet for oral use.

Drug: - LTT462

LTT462 will be supplied as hard gelatin capsule for oral use.

Drug: - Trametinib

Trametinib will be supplied as film-coated tablet for oral use

Drug: - Ribociclib

Ribociclib will be supplied in tablets and hard gelatin capsules.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

UCSF Medical Center, San Francisco, California

Status

Address

UCSF Medical Center

San Francisco, California, 94143

Florida Cancer Specialists, Fort Myers, Florida

Status

Address

Florida Cancer Specialists

Fort Myers, Florida, 33901

Tampa, Florida

Status

Address

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Mayo Clinic Mayo Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic Mayo Rochester

Rochester, Minnesota, 55905

New York, New York

Status

Address

NYU Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016

Memorial Sloan Kettering, New York, New York

Status

Address

Memorial Sloan Kettering

New York, New York, 10017

University of Pittsburgh Med Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Med Center

Pittsburgh, Pennsylvania, 15213

Univ of TX MD Anderson Cancer Cntr, Houston, Texas

Status

Address

Univ of TX MD Anderson Cancer Cntr

Houston, Texas, 77030

International Sites

Novartis Investigative Site, Caba, Buenos Aires, Argentina

Status

Address

Novartis Investigative Site

Caba, Buenos Aires, C1426ANZ

Novartis Investigative Site, North Sydney, New South Wales, Australia

Status

Address

Novartis Investigative Site

North Sydney, New South Wales, 2060

Novartis Investigative Site, Wooloongabba, Queensland, Australia

Status

Address

Novartis Investigative Site

Wooloongabba, Queensland, 4102

Novartis Investigative Site, Subiaco, Western Australia, Australia

Status

Address

Novartis Investigative Site

Subiaco, Western Australia, 6008

Novartis Investigative Site, Leuven, Belgium

Status

Address

Novartis Investigative Site

Leuven, , 3000

Novartis Investigative Site, Wilrijk, Belgium

Status

Address

Novartis Investigative Site

Wilrijk, , 2610

Novartis Investigative Site, Lille, France

Status

Address

Novartis Investigative Site

Lille, , 59037

Novartis Investigative Site, Marseille, France

Status

Address

Novartis Investigative Site

Marseille, , 13885

Novartis Investigative Site, Paris 10, France

Status

Address

Novartis Investigative Site

Paris 10, , 75475

Novartis Investigative Site, Pierre Benite, France

Status

Address

Novartis Investigative Site

Pierre Benite, , 69495

Novartis Investigative Site, Toulouse, France

Status

Address

Novartis Investigative Site

Toulouse, , 31059

Novartis Investigative Site, Villejuif, France

Status

Address

Novartis Investigative Site

Villejuif, , 94800

Novartis Investigative Site, Dresden, Germany

Status

Address

Novartis Investigative Site

Dresden, , 01307

Novartis Investigative Site, Essen, Germany

Status

Address

Novartis Investigative Site

Essen, , 45147

Novartis Investigative Site, Heidelberg, Germany

Status

Address

Novartis Investigative Site

Heidelberg, , 69120

Novartis Investigative Site, Tuebingen, Germany

Status

Address

Novartis Investigative Site

Tuebingen, , 72076

Novartis Investigative Site, Ramat Gan, Israel

Status

Address

Novartis Investigative Site

Ramat Gan, , 52621

Novartis Investigative Site, Milano, MI, Italy

Status

Address

Novartis Investigative Site

Milano, MI, 20133

Novartis Investigative Site, Napoli, Italy

Status

Address

Novartis Investigative Site

Napoli, , 80131

Novartis Investigative Site, Maastricht, Netherlands

Status

Address

Novartis Investigative Site

Maastricht, , 6229 HX

Novartis Investigative Site, Oslo, Norway

Status

Address

Novartis Investigative Site

Oslo, , 0310

Novartis Investigative Site, Lausanne, Switzerland

Status

Address

Novartis Investigative Site

Lausanne, , 1011

Novartis Investigative Site, Zuerich, Switzerland

Status

Address

Novartis Investigative Site

Zuerich, , 8091

Novartis Investigative Site, Manchester, United Kingdom

Status

Address

Novartis Investigative Site

Manchester, , M20 2BX

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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