A Multi-centre Phase II Study to Determine the Response Kinetics, Safety and Efficacy of Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma Considered Unsuitable for ABVD

Peter MacCallum Cancer Centre, Australia6 sites in 2 countries27 target enrollmentNovember 29, 2018

ConditionsHodgkin Lymphoma

Interventionspembrolizumab

Overview

Phase: Phase 2
Intervention: pembrolizumab
Conditions: Hodgkin Lymphoma
Sponsor: Peter MacCallum Cancer Centre, Australia
Enrollment: 27
Locations: 6
Primary Endpoint: Response using Lugano Criteria
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test how safe and effective the research study drug, pembrolizumab is as a treatment for patients with Hodgkin lymphoma who have not previously been treated for this disease and are unsuitable for standard treatment (adriamycin, bleomycin, vinblastine, dacarbazine ABVD).

Detailed Description

The study is a single arm, open label, phase II, international, multi-centre study. Sample size will be 25 evaluable patients with a recruitment period of 2 years. Patients will be administered 200mg pembrolizumab IV every 3 weeks up to 35 cycles or 2 years. Patients will be followed-up for 1 year.

Registry

clinicaltrials.gov

Start Date

November 29, 2018

End Date

July 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peter MacCallum Cancer Centre, Australia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have provided written informed consent for the trial.
•Be 18 years or greater on day of signing informed consent.
•Have a diagnosis of Hodgkin lymphoma.
•The patient must meet one of the following criteria:
•Considered by the investigator to be ineligible for front-line ABVD combination chemotherapy due to reasons of medical co-morbidity
•Have measurable disease based on the Lugano classification
•Have stage III or IV disease; or disease stage II disease that cannot be irradiated without unacceptable toxicity in the view of the investigator and patient.
•Be willing to provide tissue from a "newly-obtained" core or excisional biopsy of a tumour lesion. Newly-obtained is defined as a specimen obtained up to 8 weeks (56 days) prior to registration. Patients for whom newly-obtained samples cannot be provided (e.g. inaccessible or patient safety concern) may submit an archived specimen only upon agreement from the CPI.
•Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.
•Demonstrate adequate organ function as defined in Table 2, all screening labs should be performed within 10 days of registration.

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of registration.
•Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of registration. Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to registration.
•Note: Apart from steroids for palliative purposes specifically for lymphoma-associated symptoms (prednisolone 50mg or equivalent for up to 10 doses) or patients with asthma or chronic obstructive pulmonary disease that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
•Has a known history of active TB (Bacillus Tuberculosis)
•Hypersensitivity to pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (MoAb) within 4 weeks prior to registration or who has not recovered (i.e., ≤ Grade 1 at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of registration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: patients with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•Note: If a patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to registration.
•Subject has a history of other active malignancies other than HL within the past 2 years prior to study entry, with the exception of:

Arms & Interventions

Single arm

Single Arm

Intervention: pembrolizumab

Outcomes

Primary Outcomes

Response using Lugano Criteria

Time Frame: At each treatment cycle 1 to 35 (each cycle is 3 weeks)

Response will be assessed by Lugano criteria. Overall response is defined as achieving either CR or PR at any stage from time of commencement of protocol treatment to time of treatment cessation for whatever reason.

Secondary Outcomes

Adverse Events(Screening, Cycles 1-35 (each cycle is 3 weeks), end of treatment (2 years), 30 days from date of last dose, up until the first sign of progression through to study completion (3 years))
Overal Survival (OS)(up until the first sign of progression through to study completion (3 years))
Duration of response (DoR)(up until the first sign of progression through to study completion (3 years))
Response using LYRIC Criteria(At each treatment cycle 1 to 35 (each cycle is 3 weeks))
Treatment Intensity(At each treatment cycle 1 to 35 (each cycle is 3 weeks))
Progression Free Survival (PFS)(up until the first sign of progression through to study completion (3 years))
Event Free Survival (EFS)(up until the first sign of progression through to study completion (3 years))