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Hodgkin LymphomaPhase 2PLIMATHNCT03331731

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

A Phase 2 study testing pembrolizumab in people with Hodgkin Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
6 sitesin 2 countries
Study dates
29 Nov 2018to 31 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Myelodysplastic syndrome with no excess of blasts and blood count parameters meeting inclusion criteria, with no prior disease-modifying therapy.
  • 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.
  • Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy more than oral antibiotics.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the preceding 12 months.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has received a live vaccine within 30 days of registration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to registration. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Australia5 sites

  • Concord Hospital

    Concord, New South Wales, 2139

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Alfred Health

    Melbourne, Victoria, 3004

  • Linear Clinical Research

    Nedlands, Perth, 6009

Other trials in Australia

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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

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).

Read the 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.

Being tested
pembrolizumab
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabDrug

    Also called Keytruda

    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.

Study groups in NCT03331731
Study groupRoleWhat they receive
Single armExperimentalSingle Arm
Receives: Drug: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Response using LYRIC Criteria

    Response will be assessed by LYRIC criteria

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

  2. Adverse Events

    Adverse Events will be evaluated using CTCAE version 4.03 as worst grade per AE

    Measured: 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)

  3. Progression Free Survival (PFS)

    PFS will be measured from the date of treatment commencement to the date of first progression at any site or date of death from any cause

    Measured: up until the first sign of progression through to study completion (3 years)

  4. Overal Survival (OS)

    OS will be measured from the date of treatment commencement to the date death from any cause.

    Measured: up until the first sign of progression through to study completion (3 years)

  5. Treatment Intensity

    Treatment intensity will be defined as the actual total dose received divided by the actual treatment period

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

  6. Event Free Survival (EFS)

    EFS will be measured from the date of treatment commencement to date of documented disease progression at any site, date of commencement of next-line treatment, or date of death from any cause, whichever occurs first.

    Measured: up until the first sign of progression through to study completion (3 years)

  7. Duration of response (DoR)

    DoR will be assessed on patients who responded to treatment and will be measured from the date of first documented disease response to the earliest recurrence or progressive disease. Deceased patients without recurrence or progressive disease will be censored at the last disease assessment date.

    Measured: up until the first sign of progression through to study completion (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start29 Nov 2018
  3. Primary completion16 Feb 2023
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, open label, phase II, international, multicentre study
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03331731
Sponsor's protocol ID
17/158
Acronym
PLIMATH
Status last verified
Oct 2026
First submitted
10 Oct 2017
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pembrolizumab in people with Hodgkin Lymphoma, run by Peter MacCallum Cancer Centre, Australia at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response using Lugano Criteria (time frame: At each treatment cycle 1 to 35 (each cycle is 3 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03331731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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