PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers.

Sponsor
British Columbia Cancer Agency
Study ID
NCT03283943
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Focal radiotherapy — RADIATION
    Focal sensitizing radiotherapy will be given at a starting dose level of 24 Gray (6 Gy X 4 fractions), and may be escalated to 32 Gy (8Gy X4 fractions).
  • Durvalumab — DRUG
    Durvalumab 1500 mg IV every 28 days

Study Details

It is postulated that focal sensitizing radiotherapy may potentiate the effectiveness of durvalumab. The purpose of this study is to test the safety and tolerability of 2 different dose levels of focal sensitizing radiation therapy given with durvalumab.

Key Dates

Start date
Apr 1, 2018
Status verified
Jul 2018
Primary completion
Dec 16, 2020
Completion
Dec 16, 2020

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and focal radiotherapy
    Durvalumab 1500 mg IV every 28 days, and 2 fractions of focal sensitizing radiation with cycles 1 and 2 of treatment.

Primary Outcome Measure

Determine the maximum tolerated dose of durvalumab combined with focal irradiation for use in recurrent ovarian cancer [ Time Frame: First 4 weeks of therapy ]

Central Contacts

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