Actively Recruiting
NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2024-05-16
20
Participants Needed
2
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open label, phase II, randomised, non-comparative clinical trial, evaluating changes in tumour-responsive T-cells following neoadjuvant stereotactic ablative body radiotherapy (SABR) with or without pembrolizumab, prior to nephrectomy, in patients with localised primary clear cell renal cell carcinoma (ccRCC).
CONDITIONS
Official Title
NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Male or female aged 18 years or older
- Confirmed diagnosis of renal cell carcinoma with clear cell, rhabdoid, or sarcomatoid components
- Tumor stage T1B to T3, N0 or N1, M0 or low volume M1 planned for nephrectomy
- Adequate bone marrow, liver, and kidney function within 28 days prior to randomization, including:
- White blood cell count ≥ 3 x 10^9/L
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 100 g/L
- Serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 30 ml/min
- Total bilirubin ≤ 1.5 times upper limit of normal (except Gilbert's Syndrome)
- Albumin > 30 g/L
- AST and ALT ≤ 1.5 times upper limit of normal
- INR or PT ≤ 1.5 times upper limit of normal unless on anticoagulants
- ECOG performance status 0 or 1
- Women of childbearing potential must have a negative pregnancy test within 72 hours prior to randomization
- Women of childbearing potential must use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and 120 days after last dose
- Male patients must use adequate contraception from first dose through 120 days after last dose
- Agree to collection and use of fresh tumor samples and blood for research
- Willing and able to comply with study protocol including biopsies, treatment, and visits
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or antibodies targeting immune-regulatory receptors
- Known or active inflammatory bowel disease affecting colon or small bowel
- Previous radiotherapy to upper abdomen overlapping involved kidney
- Participation in another investigational study or device use within 4 weeks prior to randomization
- Diagnosis of immunodeficiency or chronic systemic steroid use over 10 mg prednisone or equivalent within 7 days prior
- Active autoimmune disease requiring systemic treatment in last 2 years (replacement therapies allowed)
- Known additional malignancy progressing or treated in last 2 years (some skin and bladder cancers excepted)
- Active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its excipients
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or C infection
- Conditions, therapies, or lab abnormalities interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Live virus vaccination within 30 days prior to randomization
- Prior solid organ transplant
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 120 days after last dose
- Contraindications for surgery
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
2
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
S
Shankar Siva, A/Prof
CONTACT
A
Arun Azad, A/Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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