A Phase Ib/II Study of Pembrolizumab With Chemotherapy in Patients With Advanced Lymphoma (PembroHeme)

Western Regional Medical Center1 site in 1 countryStarted: April 2015Last updated: June 27, 2017

ConditionsLymphoma Hodgkin's Lymphoma Non-hodgkin's Lymphoma

InterventionsPembrolizumab Etoposide Ifosfamide Mesna Carboplatin Rituximab Brentuximab vedotin

DrugsPembrolizumab Etoposide Ifosfamide Mesna Carboplatin Brentuximab vedotin Rituximab

Overview

Phase: Phase 1
Status: Withdrawn
Sponsor: Western Regional Medical Center
Locations: 1
Primary Endpoint: Determine the recommended phase 2 dose (RP2D) of chemotherapy in combination with pembrolizumab (pembro) in subjects with advanced lymphoma and complete remission by Revised Response Criteria for Malignant Lymphoma.

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

To determine the recommended phase 2 dose of chemotherapy in combination with Pembrolizumab in subjects with advanced lymphoma and determine the complete response rate.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Patient at least 18 years old and has definitive histologically or cytologically confirmed: classical Hodgkin lymphoma (HL) or diffuse large B-Cell lymphoma (DLBCL) non-Hodgkin lymphoma (NHL).
•Patient has one or more metastatic lesions \>1.5 cm as defined by lymphoma response criteria by PET-CT scan. If CT scan is needed for clarification of findings on PET-CT it may be done additionally. Tumor sites that are considered measureable must not have received prior radiation therapy.
•Patients can be enrolled only on one of the treatment arms on this trial.
•The investigator will select the appropriate treatment arm for the patient with the following requirements: (a) Patients cannot have had prior progression or intolerance on the single agent chemotherapy and then enrolled on an arm with that same single agent chemotherapy plus pembro (b) The chemotherapy on the arm selected must be considered standard of care or listed in www.nccn.org for that cancer type.
•Have recovered from acute toxicities of prior treatment:
•\> 3 weeks must have elapsed since receiving any investigational agent.
•\> 2 weeks must have elapsed since receiving any radiotherapy, or ≥ 3 weeks or 5 half-lives whichever is shorter for treatment with cytotoxic or biologic agents ( ≥ 6 weeks for mitomycin or nitrosoureas). Chronic treatment with non-investigational gonadotropin-releasing hormone analogs or other hormonal or supportive care is permitted.
•Patient has adequate biological parameters as demonstrated by the following blood counts at time of screening:
•Absolute neutrophil count (ANC) \> 1000/ microliter, platelet count ≥ 75,000/ microliter, hemoglobin ≥ 9 g/dL. Subject can be given packed red blood cell transfusion.
•Calculated creatinine clearance \> 50 ml/min by Cockroft-Gault equation, total bilirubin 1.5 times the upper limit of normal (ULN) range, AST/ALT ≤ 3 times the upper limit of normal (ULN) range.

Exclusion Criteria

•Active clinically serious infection \> Grade
•Serious non-healing wound, ulcer, or bone fracture.
•Patient has known brain metastases.
•Patient has with myelodysplasia, polycythemia vera, idiopathic thrombocythemia, myelofibrosis, or acute leukemia.
•Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
•Patient has known active infection with HIV, hepatitis B, or hepatitis C (patients will be required to be tested for the presence of such viruses prior to therapy on this protocol).
•Ejection fraction measuring less than 45% (measurement of ejection fraction is required only for subjects with prior anthracycline exposure).
•Requiring daily corticosteroid dose ≥ 10 mg prednisone or equivalent per day.
•Patient has undergone major surgery, other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
•Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindication or Special Warnings and Precautions sections of the product or comparator SmPC or Prescribing Information.