Mycosis FungoidesPhase 1/2BIOSELECTNCT05538988
BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma
A Phase 1/2 study testing Cemiplimab in people with Mycosis Fungoides, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Background - Advanced cutaneous T-cell lymphoma (mycosis fungoides, MF) is an incurable extranodal mature lymphoma with poor prognosis. Currently available therapies provide only short-term remissions. Rationale - MF is an immunogenic cancer and expresses a high number of neoantigens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2024to Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Patients with histological confirmation of mycosis fungoides; diagnosis must be confirmed by the Northern Alberta Cutaneous Lymphoma Review Board.
- Minimum disease stage(s) for enrolment: stage IIB (see appendix B).
- Patients must be 18 years of age or older.
- Patients must be capable of providing consent to enrolment and willing to comply with study treatment and follow-up.
- Patients with a performance status of ECOG 0-2(11) will be eligible for enrolment (see appendix A).
- Previous failure of ≥1 prior therapies, including PUVA (psoralen and UVA phototherapy), systemic interferon α, systemic retinoid therapy (bexarotene, alliretinoin or acitretin), systemic histone deacetylase (HDAC) inhibitor (vorinostat or romidepsin), radiation therapy or systemic chemotherapy (including, but not limited to methotrexate and gemcitabine).
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- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
- Patients of childbearing/reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
- Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.
- The following adequate organ function laboratory values must be met:
- Hematological: i. Absolute neutrophil count (ANC) ≥ 1,500 /mcL ii. Platelet count ≥100,000 / mcL iii. Hemoglobin >90 mg/dL (transfusions are permitted) b. Renal serum creatinine or (measured or calculated) creatinine clearance (GFR can also be used in place of creatinine or CrCl)≤1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels >1.5 X institutional ULN c. Hepatic: i. Total serum bilirubin <1.5 x ULN ii. AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
Who cannot join
- Known immunodeficiency (including known history of human immunodeficiency virus (HIV)).
- Active Hepatitis B or Hepatitis C. Testing for HBV or HCV is not mandatory for enrolment to study, but may occur at the discretion of the investigator. Inactive HBsAg carriers with prophylactic antiviral agent are allowed.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids doses >20 mg daily for more that 2 months, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Patients who have been previously treated with a PD(L)-1 immune checkpoint inhibitor regimen are ineligible.
- Patients with a requirement for concomitant radiation therapy are ineligible; prior treatment with radiation therapy is not exclusionary, but a wash-out period of no less than 28 days is required prior to study enrolment.
- Patients receiving immunosuppressive agents within 30 days prior to the first dose of trial treatment, including non-steroid immunosuppressive agents (e.g. anti-TNFα biologic agents, methotrexate, mycophenolate mofetil, tacrolimus) or systemic corticosteroids.
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- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class II) or serious cardiac arrhythmia requiring medication.
- Presence of a concurrent (synchronous) second primary malignancy.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on the investigator's judgment are acceptable.
- Known prior severe hypersensitivity to study drugs or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, Single-arm, Open-label Phase I/II Study Investigating the Efficacy and Safety of Anti-PD1 Immunotherapy for the Treatment of Patients With Cutaneous T-cell Lymphoma (Mycosis Fungoides)
Background - Advanced cutaneous T-cell lymphoma (mycosis fungoides, MF) is an incurable extranodal mature lymphoma with poor prognosis. Currently available therapies provide only short-term remissions.
Rationale - MF is an immunogenic cancer and expresses a high number of neoantigens. therefore it it reasonable to assume that it would respond to immune checkpoint inhibitors.
Objectives - The primary objective is to test the clinical efficacy (objective response rate) of the immune checkpoint inhibitor cemiplimab in patients with advanced mycosis fungoides (MF) who failed first-line therapy, defined as the sum of complete and partial responses (where at least 50% reduction of mSWAT is achieved).
- Conditions
- Mycosis Fungoides
- Being tested
- Cemiplimab
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called Libtayo
Cemiplimab is a recombinant human IgG monoclonal antibody known as a programmed cell death 1 (PD-1) immune checkpoint inhibitor. The PD-1 pathway is an immune system checkpoint that may be exploited by tumour cells to escape active T-cell surveillance. Cemiplimab binds to PD-1 on T cells and blocks the interaction with its ligands, PD-L1 and PD-L2. Inhibition of the receptor/ligand signaling restores the anti-tumour immune response
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab | Experimental | Study treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days) Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Efficacy of treatment will be described by an objective response rate (ORR) >50%. I.e. achieving ORR in 50% of the patients.
Measured: The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments.
Secondary outcomes (7)
Assessment of Treatment Safety
CTCAE v5.0 will be used to categorize treatment related and non-treatment related adverse events.
Measured: Adverse events will be reviewed throughout the study and the analysis will be completed 90 days following the 99 week follow-up.
Assessment of Progression Free Survival (PFS)
Progression-free survival is defined as the time between the date of treatment initiation and the date of disease progression or death
Measured: The PFS analysis will be completed 90 days following the 99 week follow-up.
Reduction in mSWAT during Therapy.
Clinical investigator will assess the patches, plaques and tumors on your skin and assign a value using a grid point system. These values will be assessed in relation to the original baseline value.
Measured: mSWAT will be assessed during screening, week 12, week 27, week 39 and week 48
Duration of Objective Response to Therapy
Duration of treatment response is defined as the elapsed time between demonstration of an objective response and subsequent progression of disease or censoring.
Measured: The duration of objective response to therapy analysis will be completed 90 days following the 99 week follow-up.
Health Related Quality of Life (EuroQol-5D)
The patient is asked to indicate his/her health state by ticking a box next to a series of questions. This decision results in a number that can be combined with the other questions to form a number that describes the patient's health state.
Measured: The EuroQol-5D questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Health Related Quality of Life (Brief Older People's Quality of Life)
The patient is asked to indicate his/her health state by ticking a box next to a series of questions. This decision results in a number that can be combined with the other questions to form a number that describes the patient's health state.
Measured: The OPQOL-Brief questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Health Related Quality of Life (Dermatological Life Quality Index)
The patient is asked to describe their skin problems by ticking a box next to a series of questions. This decision results in a number that can be combined with the other questions to form a number that describes how the patients skin problems have affected their quality of life.
Measured: The DLQI questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: Contractual Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538988
- Sponsor's protocol ID
- IIT-0028
- Acronym
- BIOSELECT
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Single-arm, Open-label Phase I/II Study Investigating the Efficacy and Safety of Anti-PD1 Immunotherapy for the Treatment of Patients With Cutaneous T-cell Lymphoma (Mycosis Fungoides)
- ClinicalTrials.gov ID
- NCT05538988
- Acronym / sponsor ID
- BIOSELECT / IIT-0028
- Conditions
- Mycosis Fungoides
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Contractual Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background - Advanced cutaneous T-cell lymphoma (mycosis fungoides, MF) is an incurable extranodal mature lymphoma with poor prognosis. Currently available therapies provide only short-term remissions.
Rationale - MF is an immunogenic cancer and expresses a high number of neoantigens. therefore it it reasonable to assume that it would respond to immune checkpoint inhibitors.
Objectives - The primary objective is to test the clinical efficacy (objective response rate) of the immune checkpoint inhibitor cemiplimab in patients with advanced mycosis fungoides (MF) who failed first-line therapy, defined as the sum of complete and partial responses (where at least 50% reduction of mSWAT is achieved).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab | Experimental | Drug: CemiplimabStudy treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histological confirmation of mycosis fungoides; diagnosis must be confirmed by the Northern Alberta Cutaneous Lymphoma Review Board.
- Minimum disease stage(s) for enrolment: stage IIB (see appendix B).
- Patients must be 18 years of age or older.
- Patients must be capable of providing consent to enrolment and willing to comply with study treatment and follow-up.
- Patients with a performance status of ECOG 0-2(11) will be eligible for enrolment (see appendix A).
Key exclusion criteria (12 listed)
- Known immunodeficiency (including known history of human immunodeficiency virus (HIV)).
- Active Hepatitis B or Hepatitis C. Testing for HBV or HCV is not mandatory for enrolment to study, but may occur at the discretion of the investigator. Inactive HBsAg carriers with prophylactic antiviral agent are allowed.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids doses >20 mg daily for more that 2 months, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Patients who have been previously treated with a PD(L)-1 immune checkpoint inhibitor regimen are ineligible.
- Patients with a requirement for concomitant radiation therapy are ineligible; prior treatment with radiation therapy is not exclusionary, but a wash-out period of no less than 28 days is required prior to study enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: LibtayoCemiplimab is a recombinant human IgG monoclonal antibody known as a programmed cell death 1 (PD-1) immune checkpoint inhibitor. The PD-1 pathway is an immune system checkpoint that may be exploited by tumour cells to escape active T-cell surveillance. Cemiplimab binds to PD-1 on T cells and blocks the interaction with its ligands, PD-L1 and PD-L2. Inhibition of the receptor/ligand signaling restores the anti-tumour immune response | Drug | Cemiplimab |
Primary outcome
Objective Response Rate
Time frame: The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments.
Efficacy of treatment will be described by an objective response rate (ORR) >50%. I.e. achieving ORR in 50% of the patients.
7 secondary outcomes
Assessment of Treatment Safety
Time frame: Adverse events will be reviewed throughout the study and the analysis will be completed 90 days following the 99 week follow-up.
Assessment of Progression Free Survival (PFS)
Time frame: The PFS analysis will be completed 90 days following the 99 week follow-up.
Reduction in mSWAT during Therapy.
Time frame: mSWAT will be assessed during screening, week 12, week 27, week 39 and week 48
Duration of Objective Response to Therapy
Time frame: The duration of objective response to therapy analysis will be completed 90 days following the 99 week follow-up.
Health Related Quality of Life (EuroQol-5D)
Time frame: The EuroQol-5D questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Health Related Quality of Life (Brief Older People's Quality of Life)
Time frame: The OPQOL-Brief questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Health Related Quality of Life (Dermatological Life Quality Index)
Time frame: The DLQI questionnaire will be administered at screening, Cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
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RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
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Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cemiplimab in people with Mycosis Fungoides, run by AHS Cancer Control Alberta at 1 site in Canada.
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 11 inclusion and 12 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: withdrawn, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective Response Rate (time frame: The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.