WIRE - Novel Treatments in Renal Cell Cancer

Sponsor
CCTU- Cancer Theme
Study ID
NCT03741426
Phase
PHASE2
Status
Unknown

Conditions

  • Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib 300mg twice daily, oral medication administered for at least 2 weeks and up until the morning of nephrectomy. Arms 2, 3 and 5
  • Cediranib — DRUG
    Cediranib 20mg once daily, oral medication administered for at least 2 weeks until 36 hours prior to nephrectomy. Arms 1 and 3
  • Durvalumab — DRUG
    Durvalumab 1500mg intravenous infusion administered once, no greater than 4 weeks prior to nephrectomy

Study Details

Evaluation of proof of mechanism with relation to ktrans and/or CD8 count when 3 different IMPs are given as monotherapy or as combination therapy. These would be administered in the "window of opportunity", prior to nephrectomy in surgically resectable renal cell cancer

Key Dates

Start date
Jul 27, 2020
Status verified
Jun 2023
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1- Cediranib
    Cediranib tablet oral 20mg once daily for a minimum of 2 weeks up until 36 hours before nephrectomy.
  • Experimental: Arm 2- Olaparib
    Olaparib tablet oral 300mg twice daily for a minimum of 2 weeks up until the morning of nephrectomy.
  • Active Comparator: Arm 3- Olaparib and Cediranib
    Olaparib tablet oral 300mg twice daily for a minimum of 2 weeks up until the morning of nephrectomy AND Cediranib tablet oral 20mg once daily for a minimum of 2 weeks up until 36 hours before nephrectomy.
  • Experimental: Arm 4- Durvalumab
    Durvalumab 1500mg intravenous infusion once, a maximum of 4 weeks prior to nephrectomy.
  • Active Comparator: Arm 5- Olaparib and Durvalumab
    Olaparib tablet oral 300mg twice daily for a minimum of 2 weeks up until the morning of nephrectomy. Durvalumab 1500mg intravenous infusion once, a maximum of 4 weeks prior to nephrectomy.

Primary Outcome Measure

Proof-of-Mechanism (ktrans): to assess for 30% ktrans change between pre-IMP treatment and IMP End of Treatment DCE-MRI [ Time Frame: Change between Screening and 72 hours before surgery ]

Central Contacts

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