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Current Clinical Trials

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started June 2024
  5. Constantin Dasanu, MD, PhD
  6. Accepting new patients

Description

Summary

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: What side effects may happen from taking the study drugs. How much study drug is in the blood at different times. Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Official Title

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma.

Keywords

Melanoma

Eligibility

for people 18 Years and up
Key Inclusion Criteria: Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol. Measurable disease per RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1. Adequate bone marrow, hepatic, and kidney function. Key Exclus... more
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Key Inclusion Criteria: Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol. Measurable disease per RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1. Adequate bone marrow, hepatic, and kidney function. Key Exclusion Criteria: Medical Conditions: Uveal, acral or mucosal melanoma. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol. Prior/Concomitant Therapy: Systemic immune suppression as described in the protocol. Other Comorbidities: Participants with a history of myocarditis. Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN). Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. After receiving his medical degree, he pursued a Ph.D. in Immunology, followed by training in Hematology & Transfusion Medicine at the Carol Davila University of Medicine in Bucharest, Romania. He then completed his residency at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at N... more
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Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. After receiving his medical degree, he pursued a Ph.D. in Immunology, followed by training in Hematology & Transfusion Medicine at the Carol Davila University of Medicine in Bucharest, Romania. He then completed his residency at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College.

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, antibody-drug conjugates, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC).

He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. Dr. Dasanu is a clinical professor at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is a recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011.

A prolific medical writer, Dr. Dasanu authored more than 250 published works in specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Immunotherapy, British Journal of Haematology, Journal of Thoracic Oncology and Nature Medicine among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal, New England Journal of Medicine and Leukemia Research.

Armed with the knowledge of science, Dr. Dasanu strongly believes that he can make a difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

To access Dr. Dasanu’s published works, please click below: https://pubmed.ncbi.nlm.nih.gov/?term=dasanu%5Bauthor%5D&sort=date

Clinical Study Details

  1. Accepting new patients
  2. study started June 2024
  4. NCT06246916
  5. Interventional
  6. November 14, 2024