EUCTR2018-001767-23-GB
Active, Not Recruiting
Phase 1
A phase II trial to investigate the safety and efficacy of rituximab and pembrolizumab in relapsed/refractory Waldenström’s macroglobulinaemia - PembroWM
niversity College London0 sites42 target enrollmentJune 19, 2019
ConditionsRelapsed and refractory Waldenström's MacroglobulinaemiaMedDRA version: 21.0Level: PTClassification code 10047801Term: Waldenstrom's macroglobulinaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsKEYTRUDA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed and refractory Waldenström's Macroglobulinaemia
- Sponsor
- niversity College London
- Enrollment
- 42
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients \=18 years old
- •2\.Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
- •3\.Presence of measurable disease, (defined as a serum IgM level of \>0\.5g/L) and fulfils other World Health Organisation (WHO) diagnostic criteria for WM
- •4\.Relapsed or refractory WM who have received \=1 prior lines of therapy
- •5\.Adequate renal function: estimated creatinine clearance \= 30ml/min as calculated using the Cockroft\-Gault equation
- •6\.Adequate liver function, including:
- •oBilirubin \=1\.5x the upper limit of normal (ULN)
- •oAspartate or alanine transferase (AST or ALT) \=2\.5 x ULN
- •7\.Adequate organ and bone marrow function:
- •oNeutrophils \=0\.75x109/L
Exclusion Criteria
- •1\.Refractory to rituximab as defined by progression on/within 6 months of finishing a rituximab based regimen
- •2\.Women who are pregnant or breastfeeding, or males expecting to conceive or father children at any point from the start of treatment until 4 months after the last administration of pembrolizumab
- •3\.Clinically significant cardiac disease within 6 months prior to registration including unstable angina or myocardial infarction, uncontrolled congestive heart failure (NYHA class III\-IV), and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction abnormalities. Stable and controlled atrial fibrillation is not an exclusion.
- •4\.History of significant cerebrovascular disease in last 6 months
- •5\.Known central nervous system involvement of WM
- •6\.Clinically significant active infection requiring antibiotic or antiretroviral therapy (including Hepatitis B, C or human immunodeficiency virus (HIV))
- •7\.Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- •8\.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- •9\.Active autoimmune disease apart from:
- •oType I diabetes or thyroid disease, controlled on medication
Outcomes
Primary Outcomes
Not specified
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