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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05549297




Registration number
NCT05549297
Ethics application status
Date submitted
26/08/2022
Date registered
22/09/2022
Date last updated
2/12/2024

Titles & IDs
Public title
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Scientific 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)
Secondary ID [1] 0 0
IMCgp100-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tebentafusp
Treatment: Drugs - Tebentafusp with Pembrolizumab
Treatment: Drugs - Investigators Choice

Experimental: Arm A: Tebentafusp Monotherapy - Participants receive tebentafusp as single agent.

Experimental: Arm B: Tebentafusp + Pembrolizumab - Participants receive tebentafusp in combination with pembrolizumab.

Experimental: Arm C: Investigator's Choice - Participants receive investigator's choice of therapy.


Treatment: Drugs: Tebentafusp
Soluble gp100-specific T cell receptor with anti-CD3 scFV

Treatment: Drugs: Tebentafusp with Pembrolizumab
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab

Treatment: Drugs: Investigators Choice
Investigators choice of therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to ~4 years
Secondary outcome [1] 0 0
Change from Baseline in Circulating Tumor DNS (ctDNA)
Timepoint [1] 0 0
Up to ~9 weeks
Secondary outcome [2] 0 0
Number of participants with =1 adverse event (AE)
Timepoint [2] 0 0
Up to ~4 years
Secondary outcome [3] 0 0
Number of participants with =1 serious adverse event (SAEs)
Timepoint [3] 0 0
Up to ~4 years
Secondary outcome [4] 0 0
Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs
Timepoint [4] 0 0
Up to ~4 years
Secondary outcome [5] 0 0
Number of participants with Grade =2 cytokine release syndrome (CRS)
Timepoint [5] 0 0
Up to ~4 years
Secondary outcome [6] 0 0
Responses to the EORTC Core Quality of Life (EORTC-QLQ-C30)
Timepoint [6] 0 0
At designated time points up to ~4 years
Secondary outcome [7] 0 0
Responses to the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Timepoint [7] 0 0
At designated time points up to ~4 years
Secondary outcome [8] 0 0
Plasma Concentration of Tebentafusp
Timepoint [8] 0 0
At designated time points up to ~4 years
Secondary outcome [9] 0 0
Number of participants with anti-tebentafusp antibodies
Timepoint [9] 0 0
At designated time points up to ~4 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [2] 0 0
Gallipoli Medical Research Foundation (GMRF) - Greenslopes
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Austria
State/province [12] 0 0
Linz
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Jette
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
France
State/province [18] 0 0
Cedex
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
France
State/province [20] 0 0
Marseille
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Erlangen
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Heidelberg
Country [29] 0 0
Germany
State/province [29] 0 0
Minden
Country [30] 0 0
Germany
State/province [30] 0 0
Muenchen
Country [31] 0 0
Germany
State/province [31] 0 0
Tübingen
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Italy
State/province [34] 0 0
Perugia
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Italy
State/province [36] 0 0
Siena
Country [37] 0 0
Poland
State/province [37] 0 0
Bydgoszcz
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Poznan
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Málaga
Country [44] 0 0
Spain
State/province [44] 0 0
Valencia
Country [45] 0 0
Switzerland
State/province [45] 0 0
Saint Gallen
Country [46] 0 0
Switzerland
State/province [46] 0 0
Zürich
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Cambridgeshire
Country [48] 0 0
United Kingdom
State/province [48] 0 0
West Midlands
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Leeds
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Middlesex
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immunocore Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Immunocore Medical Information
Address 0 0
Country 0 0
Phone 0 0
844-466-8661
Fax 0 0
Email 0 0
medical.information@immunocore.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05549297