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

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.

Conditions

Advanced Melanoma

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Advanced Melanoma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32806

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic Minnesota, Rochester, Minnesota, United States, 55905

New Brunswick

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States, 08901

Lake Success

Northwell Health Cancer Institute - Zuckerberg Cancer Center, Lake Success, New York, United States, 11042

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10068

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * HLA-A\*02:01-positive
  • * unresectable Stage III or Stage IV non-ocular melanoma
  • * archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
  • * measurable or non-measurable disease per RECIST 1.1
  • * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • * If applicable, must agree to use highly effective contraception
  • * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
  • * Must agree to provide protocol specified samples for biomarker analyses.
  • * Pregnant or lactating women
  • * diagnosis of ocular or metastatic uveal melanoma
  • * history of a malignant disease other than those being treated in this study
  • * ineligible to be retreated with pembrolizumab due to a treatment-related AE
  • * known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
  • * previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
  • * active autoimmune disease requiring immunosuppressive treatment with clinically significant cardiac disease or impaired cardiac function
  • * known psychiatric or substance abuse disorders
  • * 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.
  • * received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
  • * received cellular therapies within 90 days of study intervention
  • * 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
  • * received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
  • * have not progressed on treatment with an anti-PD(L)1 mAb
  • * have not received prior treatment with an approved anti-CTLA-4 mAb
  • * a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
  • * currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
  • * known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • * Out of range Laboratory values
  • * history of allogenic tissue/solid organ transplant

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunocore Ltd,

Study Record Dates

2028-07