Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator's Choice in HLAA*02:01-Positive Participants with Previously Treated Advanced Melanoma.
Phase 2 Objectives
Primary:
- To demonstrate ctDNA reduction in a greater percentage of participants for tebentafusp regimens versus investigator s choice
- To demonstrate improved survival in tebentafusp regimens versus investigator s choice
Secondary:
- To characterize the safety and tolerability of tebentafusp as monotherapy and in combination with pembrolizumab in participants with non-ocular advanced melanoma
- To assess the incidence of Grade ≥ 2 CRS following standardized steroid premedication regimen
- To characterize the PK of tebentafusp
- To characterize the ADA to tebentafusp
Phase 3 Objectives
Primary:
- To demonstrate survival superiority of tebentafusp regimens versus investigator s choice of therapy
Secondary:
- To demonstrate ctDNA reduction in a greater percentage of participants for tebentafusp regimens versus investigators choice
- To characterize the safety and tolerability of a tebentafusp regimen in participants with non-ocular advanced melanoma
- To assess the incidence of Grade ≥ 2 CRS following standardized steroid premedication regimen
- To characterize the ADA to tebentafusp
Pembrolizumab (MK-3475)
Chemotherapy multiple agents systemic
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Sarah Weiss MD
- Principal Investigator
Inclusion 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.
Exclusion Criteria
- 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 ipilimumab
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.