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WIRE - Novel Treatments in Renal Cell Cancer

ConditionRenal Cell Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCCTU- Cancer Theme

About this trial

Evaluation of proof of mechanism with relation to ktrans and/or CD8 count when 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years and over.

Predicted life expectancy ≥ 16 weeks.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Have biopsy proven clear cell RCC, either as part of the screening process or if undertaken prior to screening no more than 6 weeks prior to consent.

Disqualifiers

cT1a N0 M0-staged Renal Cell Cancer

Participants with brain metastases. A scan to confirm the absence of brain metastases is not required.

Participants with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to start of first dose of treatment.

History of leptomeningeal carcinomatosis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

  • Volrustomig

    Drug

    Volrustomig- 750mg intravenous infusion once, a maximum of 5 weeks prior to nephrectomy.

  • Rilvegostomig

    Drug

    Rilvegostomig- 750mg intravenous infusion once, a maximum of 5 weeks prior to nephrectomy.

Treatment groups

134 Participants
are divided into 5 treatment groups
Group A: Arm 1- CediranibExperimental treatment 1 intervention
Group B: Arm 2- OlaparibExperimental treatment 1 intervention
Group C: Arm 3- Olaparib and CediranibActive comparator 2 interventions
Group D: Arm 4- VolrustomigExperimental treatment 1 intervention
Group E: Arm 5- RilvegostomigExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proof-of-Mechanism (ktrans): to assess for 30% ktrans change between pre-IMP treatment and IMP End of Treatment DCE-MRI

Cediranib and Olaparib single IMP, Cediranib and Olaparib in combination IMP arms, having received at least 14 days' worth of IMP

Time frame
Change between Screening and 72 hours before surgery
2

Proof-of-Mechanism (CD8): to assess for 30% change between pre-IMP treatment and IMP End of Treatment in CD8 positive T-cells. This will be based on IHC assessment via histoscore

Volrustomig and Rilvegostomig, single dose of IMP

Time frame
Change between Screening and 72 hours before surgery

Secondary outcomes

1

Number of participants with, and severity of, Adverse Events

AEs are graded for severity according to the CTCAE toxicity criteria (Version 5.0)

Time frame
From consent to 3 months post-surgery
2

Change in primary tumour size assessed by DCE-MRI

Change in primary tumour size assessed by DCE-MRI

Time frame
Between days -28 to 0 and 72 hrs before surgery, having received at least 2 weeks' worth of IMP
3

Tumour Response

Assessment of tumour response according to RECIST 1.1

Time frame
Between days -28 to 0 for all patients.At 72 hrs before surgery if metastases are present,having received at least 2 wks' worth of IMP).Then every 8 wks until end of study (study ends=3 mths post surgery) or until progression

Other outcomes

Sponsors and contacts

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

CCTU- Cancer Theme

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Sponsor institution

University of Cambridge

Collaborator

AstraZeneca

Collaborator

Cancer Research UK

Collaborator

Source ClinicalTrials.gov
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