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Cutaneous T Cell LymphomaPhase 2PORTNCT03385226

A Trial Assessing the Effect of Pembrolizumab Combined with Radiotherapy in Patients with Relapsed, Refractory, Specified Stages of Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF)/Sezary Syndrome (SS)

A Phase 2 study testing Pembrolizumab and Radiotherapy in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides/Sezary Syndrome, run by University College, London at 11 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

Trial Subjects (patients), will receive single infusions of pembrolizumab every 3 weeks until disease progression or unacceptable toxicity develops. They will receive radiotherapy at week 12. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
11 sitesUnited Kingdom
Study dates
15 Jan 2019to Sep 2025
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

  • Age ≥ 18 years
  • Diagnosis of Stage IB-IVB CTCL mycosis fungoides (MF)/Sézary Syndrome (SS)
  • Have relapsed, are refractory or progressed after at least 1 systemic therapy
  • Skin biopsy at the time of or within 6 months prior to study entry
  • Patients must have a total mSWAT (modified Severity Weighted Assessment Tool) score of ≥10 OR have 2 or more measurable tumours of any size. Of this area: there should be at least 1 cutaneous lesion (MF) or a defined area of involved skin (erythrodermic MF or SS) which is an appropriate target for palliative radiotherapy. There should be an area of skin involved by measurable Mycosis Fungoides/SS that will not be irradiated (To assess the abscopal effect of radiotherapy)
  • Have a minimum wash-out and adverse event (AE) recovery period from previous treatments (e.g. topical therapy, phototherapy, local radiotherapy, monoclonal antibody, systemic cytotoxic anticancer treatment or other novel agents) prior to the first dose of pembrolizumab
Show all 35Show fewer
  • Have ECOG performance status of 0 or 1
  • Life expectancy of at least 6 months
  • Demonstrate adequate organ function
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test at pre-registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Willing to comply with the contraception requirements
  • Written informed consent
  • •Exclusion Criteria:
  • Received chemotherapy or targeted small molecule therapy within 4 weeks prior to study entry or has not recovered from adverse events due to agents administered >4 weeks earlier (except patients with ≤ grade 2 neuropathy)
  • Is currently or has participated in an IMP or device study within 4 weeks prior to the first dose of pembrolizumab
  • Received any other monoclonal antibody within 15 weeks prior to the first dose of pembrolizumab or has not recovered (≤ grade 1 or to baseline level) from adverse events due to agents administered >4 weeks earlier. The exception to this is alemtuzumab which should not have been administered in the previous 12 weeks
  • Additional malignancy that is progressing or requires active treatment
  • Patients with known central nervous system (CNS) involvement with lymphoma
  • Hypersensitivity to pembrolizumab or its excipients
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Stable use of corticosteroids (at a dose no higher than 10mg prednisolone per day over the preceding 4 weeks) is allowed
  • Diagnosis of prior immunodeficiency or organ-transplant requiring immunosuppressive therapy
  • Current or prior use of immunosuppressive therapy within 7 days prior to start of treatment except the following: intranasal, inhaled, topical steroids or local steroid injections (eg. Intra-articular injection); systemic corticosteroids at physiologic doses (10mg/day or less of prednisolone or equivalent)
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
  • Has known history of, or any evidence of active, non-infectious pneumonitis
  • History of other pulmonary disease such as interstitial lung disease, emphysema or chronic obstructive pulmonary disease
  • Is pregnant or breastfeeding
  • Has a known history of active TB
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial or to participate in the trial is not in the patient's best interest, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with the requirements of the trial
  • Has a known history of HIV
  • Has known active Hepatitis B or Hepatitis C
  • Has received a live vaccine within 30 days prior to the planned start of study medication
  • Patients who have previously received a solid organ transplant
  • Patients who have previously received any allogeneic transplantation

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United Kingdom11 sites

  • University Hospital Birmingham

    Birmingham

  • Velindre Cancer Centre

    Cardiff

  • University Hospital Coventry

    Coventry

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • Guy's & St Thomas'

    London

  • The Christie

    Manchester

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

  • Freeman Hospital

    Newcastle

  • Nottingham City Hospital

    Nottingham

  • Churchill Hospital

    Oxford

  • Southampton University Hospital

    Southampton

Other trials in United Kingdom

About this study

Official title: Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T-cell Lymphoma

Trial Subjects (patients), will receive single infusions of pembrolizumab every 3 weeks until disease progression or unacceptable toxicity develops. They will receive radiotherapy at week 12.

Read the detailed description

Trial Subjects (patients) who are deemed eligible for the trial will be administered a single infusion of pembrolizumab (200mg) every 3 weeks. At week 12, patients will be planned to start radiotherapy at a dose of 12 Gray (Gy) in 3 fractions which will be given concomitantly with pembrolizumab. Patients who progress on pembrolizumab before week 12 will start radiotherapy as soon as possible after progression. Following completion of radiotherapy, patients will continue receiving pembrolizumab at 3 weekly intervals for a maximum of 2 years until disease progression or unacceptable toxicity develops. Patients on pembrolizumab will be seen every 3 weeks until 2 years after study entry, while Patients who progressed/ stopped pembrolizumab will be seen annually for survival/disease status only. Patients completing 2 years of treatment will then be followed up annually for survival and disease status until the end of trial is declared (2 years after the last patient is registered).

Being tested
Pembrolizumab, Radiotherapy
Keywords
Relapsed, Refractory
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome, Recurrence

What participants receive

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

  • PembrolizumabDrug

    Also called Chemical Abstract Service (CAS) number - 1374853-91-4

    Pembrolizumab is a humanised monoclonal antibody which targets the programmed cell death 1 (PD-1) receptor. It blocks a protective mechanism on cancer cells, and allows the immune system to destroy those cancer cells.

  • RadiotherapyRadiation

    12Gy in 3 fractions

Study groups in NCT03385226
Study groupRoleWhat they receive
Pembrolizumab with radiotherapyExperimentalAll patients will receive * single 200mg pembrolizumab IV infusions given 3-weekly until 2 years post study entry, termination of treatment, disease progression or unacceptable toxicity * radiotherapy, 12Gy in 3 fractions
Receives: Drug: Pembrolizumab; Radiation: Radiotherapy

What is being measured

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

  1. Overall Response (Global Assessment)

    Overall Response of the combination of pembrolizumab plus radiotherapy

    Measured: 24 weeks after commencement of pembrolizumab

Secondary outcomes (7)

  1. Response

    Response at the 5th infusion of pembrolizumab, typically 12 weeks after start of treatment

    Measured: 12 weeks after start of pembrolizumab

  2. Change in Global Response

    Change in Global Response from the 5th infusion to the 9th infusion, typically from week 12 to week 24

    Measured: 24 weeks after start of pembrolizumab

  3. Safety and toxicity

    Number \& Percentage of patients who suffer grade 3 or 4 toxicity

    Measured: 5 months after last dose of pembrolizumab (anticipated 2 years and 5 months after last patient being registered)

  4. Response Duration

    Duration of tumour response

    Measured: Time from date of first confirmed response to the first date of diagnosis of progressive disease or death from any cause (anticipated by 2 years and 5 months after the last patient being registered)

  5. Progression Free Survival

    Disease progression or death

    Measured: Time from date of registration to the date of first progression or death from any cause ((anticipated by 2 years and 5 months after the last patient being registered)

  6. Overall Survival

    Death

    Measured: Time from date of registration to the date of death from any cause ((anticipated by 2 years and 5 months after the last patient being registered)

  7. Number of patients achieving abscopal effect

    Measured: Through study completion, 2 years post last patient being registered

Timeline

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

  1. First posted28 Dec 2017
  2. Study start15 Jan 2019
  3. Primary completion1 Sep 2023
  4. Study completionSep 2025 (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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03385226
Sponsor's protocol ID
UCL/17/0053
Other IDs
2017-000433-30, 2017
Acronym
PORT
Status last verified
Dec 2024
First submitted
12 Dec 2017
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Narducci MG, Tosi A, Frezzolini A, Scala E, Passarelli F, Bonmassar L, Monopoli A, Accetturi MP, Cantonetti M, Antonini Cappellini GC, De Galitiis F, Rosato A, Picozza M, Russo G, D'Atri S. Reduction of T Lymphoma Cells and Immunological Invigoration in a Patient Concurrently Affected by Melanoma and Sezary Syndrome Treated With Nivolumab. Front Immunol. 2020 Sep 25;11:579894. doi: 10.3389/fimmu.2020.579894. eCollection 2020.

    PubMed 33072126

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Radiotherapy in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides/Sezary Syndrome, run by University College, London at 11 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 35 inclusion and 0 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

Overall Response (Global Assessment) (time frame: 24 weeks after commencement of pembrolizumab). 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 NCT03385226, which also lists 1 linked publication.

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 9 Dec 2024.

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