SBRT + Immunotherapy for Kidney Cancer

(CYTOSHRINK Trial)

Recruiting at 7 trial locations

Overseen By Lisa Rudd-Scott, RN BScN MN

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ontario Clinical Oncology Group (OCOG)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if adding targeted radiation therapy to standard immunotherapy drugs can better treat advanced kidney cancer. It focuses on patients with advanced kidney cancer who can't have surgery. The treatment works by boosting the immune system and directly targeting the tumor with radiation. Evidence suggests that targeted radiation therapy can impact anti-tumor immune responses, and may potentially be combined with immunotherapy for synergistic effect.

Research Team

Aly-Khan Lalani, MD

Principal Investigator

Juravinski Cancer Centre

Eligibility Criteria

This trial is for adults with biopsy-proven metastatic kidney cancer, who haven't had systemic therapy for it and can lie still for at least 30 minutes. They should be at an intermediate/poor risk level and have a primary kidney lesion small enough (<20 cm) to be treated with SBRT. Patients must not have plans for nephrectomy, previous abdominal radiation that prevents SBRT use, severe autoimmune disorders, or be on chronic immune suppressive drugs.

Inclusion Criteria

My kidney cancer diagnosis was confirmed with a biopsy.

My kidney tumor can be treated with targeted radiation.

My condition is considered intermediate or poor risk.

Exclusion Criteria

I've had radiation in my abdomen that prevents further targeted radiation.

I only use herbal medicines if they are prescribed by my doctor.

I have an autoimmune disease that prevents me from taking certain cancer treatments.

Treatment Details

Interventions

• Ipilimumab/Nivolumab (Checkpoint Inhibitor)
• SBRT (Radiation)

Trial Overview The study compares two approaches: one group will receive standard care ipilimumab/nivolumab (I/N) treatment alone; the other group will get I/N plus stereotactic body radiation therapy (SBRT). The goal is to see if adding SBRT improves outcomes in metastatic kidney cancer patients.

Participant Groups

Group I: Standard of Care I/N plus primary disease SBRT Experimental Treatment 1 Intervention

induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.

Group II: Standard of Care I/N alone Active Control 1 Intervention

induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.

Ipilimumab/Nivolumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Yervoy/Opdivo for:

• Melanoma
• Non-Small Cell Lung Cancer (NSCLC)
• Hepatocellular Carcinoma (HCC)

Approved in Canada as Yervoy/Opdivo for:

• Melanoma
• Non-Small Cell Lung Cancer (NSCLC)
• Hepatocellular Carcinoma (HCC)
• Colorectal Cancer (MSI-H or dMMR)

Who Is Running the Clinical Trial?

Ontario Clinical Oncology Group (OCOG)

Lead Sponsor

Trials

65

Recruited

42,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania