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CancerPhase 2NCT03847649

A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

A Phase 2 study testing Durvalumab, Prednisone and Tremelimumab in people with Cancer, run by Canadian Cancer Trials Group at 11 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Durvalumab, Prednisone and Tremelimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
11 sitesCanada
Study dates
9 Mar 2020to 30 Apr 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

None listed.

Who cannot join

  • In general, patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are not eligible.
  • History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.
  • Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.
  • History of hypersensitivity to durvalumab or any excipient.
  • Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.
  • Documented progressive disease (PD) while on initial immunotherapy. Exception: patients who had iUPD but continued on immunotherapy, and did not have documented iCPD within 8 weeks of discontinuing immunotherapy
Show all 23Show fewer
  • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  • Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
  • Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).
  • Active peptic ulcer disease or gastritis.
  • Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.
  • Patients with diabetes mellitus are eligible but must be clinically stable on therapy (if applicable) and investigator and patient should be aware of the potential risk of immune mediated pancreatic toxicity and B cell destruction.
  • Pregnant or lactating women
  • Substudy B: Inclusion Criteria
  • Patients must be currently enrolled and receiving active treatment on a treatment arm containing durvalumab +/- tremelimumab with or without maintenance pemetrexed with no contraindications to continue receiving their current study regimen according to the protocol to which the patient is currently enrolled.
  • For BR.34 ONLY: patients who have disease progression (iUPD) on durvalumab may receive one dose of tremelimumab (75 mg) along with their next durvalumab infusion as long as all the following criteria are met:
  • Patient is clinically stable
  • According to the judgement of the treating physician, the patient had clinical benefit while receiving tremelimumab in the induction phase on BR.34
  • ECOG performance status of 0 or 1
  • Laboratory values meet the criteria below:
  • Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN (upper limit of normal) AST and ALT ≤ 2.5 x ULN (if liver metastases are present, ≤ 5.0 x ULN) Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 45 mL/min

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pierre-Olivier Gaudreau contact

613-533-6430

p-ogaudreau@ctg.queensu.ca

11 sites in 1 country

Canada11 sites, 10 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Quincy Chu, 780 432-8248

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Peter Ellis, 905 387-9495

    Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

    Sara Kristina Taylor, 250 712-3996

    Recruiting

  • Waterloo Regional Health Network (WRHN)

    Kitchener, Ontario, N2G 1G3

    Stacey Hubay, 519 749-4370 ext. 5262

    Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Normand Blais, 514 890-8444

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Scott Laurie, 613 737-7700 ext. 70173

    Recruiting

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

    Anthony J. Reiman, 506 648-6884

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Nayyer Iqbal, 306 655-2710

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Penelope A. Bradbury, 416 946-4501 ext. 3544

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Christian Kollmannsberger, 604 877-6000 ext. 2734

    Recruiting

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

    Withdrawn

Other trials in Canada

About this study

Official title: A Phase II Study of Durvalumab Treatment Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects.

I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)

Read the detailed description

Durvalumab is a new type of drug for many types of cancer. Durvalumab is an immunotherapy drug and not a chemotherapy drug. Laboratory tests show that it works by allowing the immune system (PD-1 and PD-L1 interaction) to detect your cancer and reactivating the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in more than 6000 people. This drug seems promising but it is not clear if it can offer better results than standard treatment alone or if people can be re-treated with durvalumab after previous side effects

Conditions
Cancer
Medical subject headings
Neoplasms

What participants receive

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

  • DurvalumabDrug

    1500 mg IV, 60 min, Day 1 every 4 weeks

  • PrednisoneDrug

    0.5mg/kg; PO, Daily cycles 1 \& 2

  • PrednisoneDrug

    10mg, PO, Daily cycles 1 \& 2

  • TremelimumabDrug

    Patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)

Study groups in NCT03847649
Study groupRoleWhat they receive
Cohort 1: High RiskActive comparatorNot described
Receives: Drug: Durvalumab; Drug: Prednisone
Cohort 2: Standard Risk - Arm AActive comparatorNot described
Receives: Drug: Durvalumab; Drug: Prednisone
Cohort 2: Standard Risk - Arm BActive comparatorNot described
Receives: Drug: Durvalumab; Drug: Tremelimumab

What is being measured

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

  1. Substudy A: Number and severity of adverse events

    To determine the safety and toxicity profile of rechallenging with durvalumab in patients who previously discontinued immunotherapy due to irAE.

    Measured: 2 years

  2. Substudy B: To facilitate continued treatment with durvalumab (+/- Tremelimumab) for patients currently enrolled on completed CCTG trials

    Measured: 2 years

  3. Substudy B: Number and severity of adverse events

    Measured: 2 years

Secondary outcomes (3)

  1. Substudy A:Objective response rate RECIST 1.1

    Measured: 2 years

  2. Substudy A: Objective response rate iRECIST

    Measured: 2 years

  3. Substudy A: Efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs as estimated by the percentages of patients who received corticosteroids and developed recurrent or new grade 2 or higher irAEs

    Measured: 2 years

Timeline

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

  1. First posted20 Feb 2019
  2. Study start9 Mar 2020
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2031 (estimated)

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
Randomised
Intervention model
Factorial
Model description
Cohort 1: High Risk - Receives Durvalumab plus Prednisone Cohort 2: Standard Risk - Randomize 1:1 * Arm A: Durvalumab plus prednisone * Arm B: Durvalumab (+/- tremelimumab) For BR34 pts only: Durvalumab (+/- Tremelimumab)
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847649
Sponsor's protocol ID
I238
Status last verified
Jun 2026
First submitted
19 Feb 2019
Last updated
15 Sep 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 Durvalumab, Prednisone and Tremelimumab in people with Cancer, run by Canadian Cancer Trials Group at 11 sites in Canada.

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 0 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pierre-Olivier Gaudreau (613-533-6430, p-ogaudreau@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy A: Number and severity of adverse events (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT03847649.

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 15 Sep 2026.

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