- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538988
BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (BIOSELECT)
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).
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G1Z2
- Cross Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- 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:
a. 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cemiplimab
Study treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days)
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments.
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Efficacy of treatment will be described by an objective response rate (ORR) >50%.
I.e.
achieving ORR in 50% of the patients.
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The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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CTCAE v5.0 will be used to categorize treatment related and non-treatment related adverse events.
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Adverse events will be reviewed throughout the study and the analysis will be completed 90 days following the 99 week follow-up.
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Assessment of Progression Free Survival (PFS)
Time Frame: The PFS analysis will be completed 90 days following the 99 week follow-up.
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Progression-free survival is defined as the time between the date of treatment initiation and the date of disease progression or death
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The PFS analysis will be completed 90 days following the 99 week follow-up.
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Reduction in mSWAT during Therapy.
Time Frame: mSWAT will be assessed during screening, week 12, week 27, week 39 and week 48
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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.
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mSWAT will be assessed during screening, week 12, week 27, week 39 and week 48
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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.
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Duration of treatment response is defined as the elapsed time between demonstration of an objective response and subsequent progression of disease or censoring.
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The duration of objective response to therapy analysis will be completed 90 days following the 99 week follow-up.
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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)
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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.
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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)
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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)
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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.
|
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)
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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)
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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.
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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)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Mycoses
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Cemiplimab
Other Study ID Numbers
- IIT-0028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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