RECRUITING

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.

Official Title

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)

Quick Facts

Study Start:2022-12-19
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05549297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HLA-A\*02:01-positive
  2. * unresectable Stage III or Stage IV non-ocular melanoma
  3. * archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
  4. * measurable or non-measurable disease per RECIST 1.1
  5. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  6. * If applicable, must agree to use highly effective contraception
  7. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
  8. * Must agree to provide protocol specified samples for biomarker analyses.
  1. * Pregnant or lactating women
  2. * diagnosis of ocular or metastatic uveal melanoma
  3. * history of a malignant disease other than those being treated in this study
  4. * ineligible to be retreated with pembrolizumab due to a treatment-related AE
  5. * known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
  6. * previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
  7. * active autoimmune disease requiring immunosuppressive treatment with clinically significant cardiac disease or impaired cardiac function
  8. * known psychiatric or substance abuse disorders
  9. * received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication who have not completed adequate washout from prior medications.
  10. * received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
  11. * received cellular therapies within 90 days of study intervention
  12. * ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study
  13. * received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
  14. * have not progressed on treatment with an anti-PD(L)1 mAb
  15. * have not received prior treatment with an approved anti-CTLA-4 mAb
  16. * a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
  17. * currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
  18. * known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
  19. * Out of range Laboratory values
  20. * history of allogenic tissue/solid organ transplant

Contacts and Locations

Study Contact

Immunocore Medical Information
CONTACT
844-466-8661
medical.information@immunocore.com
Immunocore Medical Information EU
CONTACT
+00 800-744-51111
medinfo.eu@immunocore.com

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Lake Success, New York, 11042
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10068
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania, 19107
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Houston Methodist Hospital/Houston Methodist Cancer Center
Houston, Texas, 77030
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Immunocore Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-19
Study Completion Date2028-07

Study Record Updates

Study Start Date2022-12-19
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Melanoma
  • IMCgp100
  • Tebentafusp
  • Cutaneous Melanoma
  • Immunotherapy
  • gp100
  • TCR
  • Pembrolizumab
  • Bispecific T cell receptor fusion protein
  • ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer)
  • Immune mobilizing monoclonal T cell receptor against cancer
  • KIMMTRAK
  • Acral Melanoma
  • Mucosal Melanoma
  • Blue Nevus
  • anti-PDL1
  • checkpoint therapy

Additional Relevant MeSH Terms

  • Advanced Melanoma