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Melanoma (Skin)Phase 2TebeMRDNCT05315258

Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma

A Phase 2 study testing Tebentafusp in people with Melanoma (Skin) and Melanoma, Uveal, run by University of Oxford at 10 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Researchers are trying to find ways to improve the management of people with intermediate or high risk resected cutaneous melanoma or with primary uveal melanoma. This research study is investigating using a new blood test to decide when to give a drug called tebentafusp. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin), Melanoma, Uveal
What is being tested?
Tebentafusp
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
10 sitesUnited Kingdom
Study dates
25 Jul 2022to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient will be eligible for inclusion in cohort A or B if all of the following criteria apply:
  • Uveal or cutaneous melanoma with MRD detected in molecular screening, and repeat confirmation of MRD in the sample taken as part of screening for the main study.
  • Written (signed and dated) informed consent.
  • Male or female, Age 18 years and above.
  • Life expectancy of at least 3 months.
  • ECOG performance score of 0 or 1.
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  • No evidence of metastatic disease on a CT scan of neck/thorax/abdomen/pelvis for cohorts A and B and also on MRI liver for uveal melanoma for cohort B.
  • Those receiving prior immunotherapy must have recovered from any immune-mediated adverse events (≤ grade 1) other than endocrinopathies on stable replacement therapy.
  • Haematological and biochemical indices within normal ranges (refer to protocol for ranges)

Who cannot join

  • A patient will not be eligible for tebentafusp administration if any of the following apply:
  • Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to enrolment.
  • Uveal or cutaneous melanoma patients who present radiologically or clinically detectable disease during screening.
  • Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy before Screening is initiated
  • Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
  • Any other active malignancy, with the exception of malignancies that were treated curatively and have not recurred within 2 years after completion of treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
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  • Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV. This study does not require testing to confirm eligibility unless clinically indicated.
  • Clinically significant cardiac disease or impaired cardiac function (New York Heart Association grade ≥ 2), including myocardial infarction or unstable angina pectoris within 6 months of screening.
  • Active autoimmune disease or a documented history of autoimmune disease within 3 years of screening (diabetes mellitus, vitiligo, managed hypothyroidism, psoriasis and managed asthma are not exclusions).
  • Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and any prior immunotherapy approach, 4 weeks is indicated as washout period
  • Presence of NCI CTCAE ≥ grade 2 toxicity (except alopecia, peripheral neuropathy, and ototoxicity, which are excluded if ≥ NCI CTCAE grade 3) due to prior cancer therapy.
  • Patients currently requiring chronic, systemic corticosteroid therapy at any dose for longer than 2 weeks. Replacement treatment for pituitary or adrenal insufficiency is permitted. Local steroid therapies (e.g. otic, ophthalmic, intra-articular, or inhaled medications) are acceptable.
  • Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment. Non-live vaccination (e.g. influenza) are permitted anytime during treatment.
  • Major surgery as defined by the investigator within 2 weeks of the first dose of study treatment (minimally invasive procedures such as bronchoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
  • Pregnant or lactating women, or women of childbearing potential unless effective methods of contraception are used.
  • Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician.
  • Male patients must be surgically sterile or use double barrier contraception method from enrolment through treatment and for 6 months following administration of the last dose of study drug.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United Kingdom10 sites

  • Cambridge University Hospitals NHS Foundation Trust (Screening only)

    Cambridge

  • The Beatson West of Scotland Cancer Centre

    Glasgow

  • The Clatterbridge Cancer Centre

    Liverpool

  • University College London Hospital

    London

  • The Christie Hospital

    Manchester

  • Mount Vernon Cancer Centre

    Middlesex

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle

  • Churchill Hospital, Oxford University Hospitals NHS Trust

    Oxford, OX3 7LE

  • Sheffield Teaching Hospitals NHS Foundation Trust (Screening only)

    Sheffield

  • University Hospital Southampton NHS Foundation Trust

    Southampton

Other trials in United Kingdom

About this study

Official title: A Phase II Non-Randomized, Open-label, Multi-centre Study of the Safety and Efficacy of Tebentafusp in Melanoma With Molecular Relapsed Disease

Researchers are trying to find ways to improve the management of people with intermediate or high risk resected cutaneous melanoma or with primary uveal melanoma.

This research study is investigating using a new blood test to decide when to give a drug called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help patients with cutaneous or uveal melanoma live longer.

Read the detailed description

TebeMRD is an unblinded non-randomised, open labelled, safety and efficacy study involving 2 patient cohorts:

  • A: Cutaneous melanoma with molecular relapsed disease (MRD)
  • B: Uveal melanoma with MRD

Approximately 850 patients (600 cutaneous melanoma, 250 uveal melanoma) will be enrolled from 50 centres to screen for HLA-A*0201 status and then followed for up to 24 months for MRD at those same centres. Patients identified with MRD will be invited to be treated with tebentafusp at up to 10 treating centres in the UK. Patients in cohorts A and B will receive up to six months of tebentafusp, administered weekly IV, and then will be followed-up for 12 months for molecular and clinical relapse.

Patients will be in the pre-screening phase for determination of HLA-A*0201 status for up to 2 weeks. Those patients who are positive for HLA-A*0201 will be followed for MRD and will attend the clinical sites for 3 monthly testing for up to 24 months. Patients will leave the study if no molecular relapse is detected during the molecular screening period. When MRD is identified, patients will be evaluated for eligibility to enter the main study at one of up to 10 specialist treatment centres, where patients will enter the screening period for determination of eligibility to start tebentafusp administration within 6 weeks. After a maximum 6 months treatment patients will be followed up for 12 months, or until the study is completed, if this is longer.

Being tested
Tebentafusp
Keywords
D008545
Medical subject headings
Melanoma, Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TebentafuspDrug

    Also called IMCgp100

    Tebentafusp supplied as concentrate for solution for infusion and diluted prior to administration. 0.2 mg/mL drug product will be provided as a sterile, refrigerated solution in glass vials.

Study groups in NCT05315258
Study groupRoleWhat they receive
Cutaneous melanoma with molecular relapsed diseaseExperimentaltebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.
Receives: Drug: Tebentafusp
Uveal melanoma with molecular relapsed diseaseExperimentaltebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.
Receives: Drug: Tebentafusp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the rate of molecular response (MR) to tebentafusp in each of 2 cohorts A. Cutaneous melanoma with MRD B. Uveal melanoma with MRD

    Best response to treatment, with partial molecular response (pMR) defined as a decrease in the allele frequency of the index mutation(s), and complete molecular response (cMR) as no detectable mutation(s)

    Measured: ctDNA taken at baseline until end of treatment (maximum of 6 months)

Secondary outcomes (3)

  1. Efficacy of tebentafusp

    Evaluate the efficacy of tebentafusp in each cohort - Relapse free survival at 12 months; duration of MR; overall survival

    Measured: ctDNA taken at baseline until end of treatment (maximum of 6 months); CT or MRI assessment as per standard of care

  2. Safety and tolerability of tebentafusp

    Assess the safety and tolerability of tebentafusp in MRD. Incidence and severity of adverse events according to NCIC CTCAE v5.0/2019 Lee et all criteria; dose reductions, interruptions and cessations in the course of treatment

    Measured: Up to 6 months of treatment

  3. Assess the rate of molecular relapse in; A. Cutaneous melanoma B. Uveal melanoma

    Percentage of patients with molecular relapse at baseline, within 6 months and over 12 months of monitoring

    Measured: ctDNA taken at baseline and every 3 months during molecular screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start25 Jul 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05315258
Sponsor's protocol ID
OCTO_101
Other IDs
2019-003946-34, 2019
Acronym
TebeMRD
Status last verified
Jul 2025
First submitted
23 Aug 2021
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tebentafusp in people with Melanoma (Skin) and Melanoma, Uveal, run by University of Oxford at 10 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the rate of molecular response (MR) to tebentafusp in each of 2 cohorts A. Cutaneous melanoma with MRD B. Uveal melanoma with MRD (time frame: ctDNA taken at baseline until end of treatment (maximum of 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05315258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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