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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

ConditionCancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically and/or cytologically confirmed solid tumour, that is advanced/ metastatic/recurrent or unresectable and for which no curative therapy exists.

Patients must live within Canada and have received durvalumab alone, or durvalumab in combination with tremelimumab, with or without chemotherapy/targeted therapy. Patients who have received other anti PD-1/PD-L1 agents +/- anti CTLA agents are eligible, providing full details of prior therapy, toxicity and management are available. Consult with CCTG for further details.

Patients must have previously discontinued immunotherapy due to an irAE.

Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Durvalumab

    Drug

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

  • Prednisone

    Drug

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

  • Prednisone

    Drug

    10mg, PO, Daily cycles 1 \& 2

  • Tremelimumab

    Drug

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Cohort 1: High RiskActive comparator 2 interventions
Group B: Cohort 2: Standard Risk - Arm AActive comparator 2 interventions
Group C: Cohort 2: Standard Risk - Arm BActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
2 years
2

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

Time frame
2 years
3

Substudy B: Number and severity of adverse events

Time frame
2 years

Secondary outcomes

1

Substudy A:Objective response rate RECIST 1.1

Time frame
2 years
2

Substudy A: Objective response rate iRECIST

Time frame
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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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