A Phase II Study to Determine Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma

NCT03331731 | Unknown Phase 2 DMC

• 1 other identifier: 17/158
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 6

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).

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response using Lugano Criteria

  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.

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

Secondary Outcomes (7)

• Response using LYRIC Criteria

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

• 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)

• Progression Free Survival (PFS)

  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)

• Treatment Intensity

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

Study Arms (1)

Single arm

EXPERIMENTAL

Single Arm

Drug: pembrolizumab

Interventions

pembrolizumab DRUG

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Also known as: Keytruda

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Age ≥65
• 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.
• Female patient of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 7.14 - Contraception, for the course of the study through 120 days after the last dose of study medication.
• Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
• Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in Section 7.14 - Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

You may not qualify if:

• 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:
• Adequately treated carcinoma in situ of the cervix uteri
• Adequately treated basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and less than 10% risk of recurrence in next 12 months.
• Untreated monoclonal B lymphocytosis or chronic lymphocytic leukaemia stage 0 with \<50% increase in lymphocyte count in preceding 6 months or absolute lymphocyte count of \<10 x10\^9/L.
• Low-risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score ≤6 and PSA ≤10ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of \> 12 months for which the management plan is active surveillance
• Has 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (6)

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

Linear Clinical Research

Nedlands, Perth, 6009, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Dickinson

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, open label, phase II, international, multicentre study

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 6, 2017
• Study Start: November 29, 2018
• Primary Completion: February 16, 2023
• Study Completion: July 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (5)