A Trial of Radiotherapy and Durvalumab in DLBCL and FL

Sponsor
Austin Health
Study ID
NCT03610061
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    All patients will receive: Day 1-Day 5: External Beam Radiotherapy to target site(s)-daily for 5 days (i.e. 5 fractions). D2: Commence durvalumab. Continue 4-weekly until disease progression. Patients can continue until a second radiological progression if clinical benefit is ongoing.
  • Radiotherapy — RADIATION
    All patients will receive: Day 1-Day 5: External Beam Radiotherapy to target site(s)-daily for 5 days (i.e. 5 fractions). D2: Commence durvalumab. Continue 4-weekly until disease progression. Patients can continue until a second radiological progression if clinical benefit is ongoing.
  • Radiotherapy (cohort 6 only) — RADIATION
    Cohort 6 patients (only) will receive: Day 8-Day 10: External Beam Radiotherapy to target site(s)- daily (ie. 5 further fractions to a total of 10 fractions)

Study Details

The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor. Primary endpoint: Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL. Secondary endpoints: * ORR * Progression-free survival * Overall survival Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C.

Key Dates

Start date
Nov 1, 2018
Status verified
Apr 2024
Primary completion
Apr 5, 2023
Completion
Apr 8, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy plus Durvalumab
    A minimum of 3 patients will initially be enrolled in each cohort of this arm. Patients will be allocated to a radiotherapy dose and site cohort from the schedule at registration. There will be no intra-patient dose or site escalations. Cohorts will escalate in number of anatomical sites of radiotherapy and dose of radiotherapy given subject to safety. Durvalumab will be administered at a fixed dose every 4 weeks IV.

Primary Outcome Measure

Number of participants treated with radiotherapy and durvalumab with treatment-related adverse events as assessed using CTCAE v4.0. To determine the maximum tolerated dose (MTD). [ Time Frame: First 28 days of treatment ]

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