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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03847649
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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)

Key Dates

Start date
Mar 9, 2020
Status verified
May 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: High Risk
  • Active Comparator: Cohort 2: Standard Risk - Arm A
  • Active Comparator: Cohort 2: Standard Risk - Arm B

Primary Outcome Measure

Substudy A: Number and severity of adverse events [ Time Frame: 2 years ]

Central Contacts

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