Phase II Trial of Pembrolizumab and Radiotherapy in Cutaneous T cell lymphoma - PORT

niversity College London0 sites46 target enrollmentJuly 4, 2018

ConditionsCutaneous T cell lymphoma MedDRA version: 22.0Level: PTClassification code 10011677Term: Cutaneous T-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsPembrolizumab (MK-3475)KEYTRUDA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cutaneous T cell lymphoma
Sponsor: niversity College London
Enrollment: 46
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 4, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity College London

Eligibility Criteria

Inclusion Criteria

•\-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:
•o 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 (see radiotherapy section 8\.3\.2 for protocol defined min/max
•irradiated area)

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.
•\-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