Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NAPSTER : NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Multiple treatment types,Radiotherapy,Surgical,Systemic therapy | Urinary systemRenal cell carcinoma

Trial Overview Read MoreRead more

This phase II study is evaluating the effect of immunotherapy (pembrolizumab) before treatment with radiation therapy and surgery to remove the kidney, in people with cancer of the kidney .
 

This trial is treating patients with renal cell carcinoma.

This is a systemic therapy, radiation therapy and surgical trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

Summary

Eligible participants will be randomly allocated to either the Active Comparator Arm or the Experimental Arm. In the Active Comparator Arm, participants will receive Stereotactic Ablative Radiotherapy (SABR) plus nephrectomy (surgical removal of the kidney). SABR will be prescribed at a dose of 42Gy in 3 fractions. All radiation therapy treatment will be completed within 3 weeks. Participants will then undergo nephrectomy within 9-12 weeks after the first dose of treatment. In the Experimental Arm, participants will receive pembrolizumab followed by SABR plus nephrectomy. Pembrolizumab (200mg, flat dose) will be administered as a 30 minute intravenous infusion every 21 days for 3 cycles. Participants will receive 1 cycle of pembrolizumab prior to SABR followed by an additional 2 cycles of pembrolizumab (1 cycle is 21 days). Participants will then undergo nephrectomy 9-12 weeks after beginning treatment.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Richelle Linklater
PCCTU.MoncA@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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