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Checkpoint Inhibitor

SBRT + Immunotherapy for Kidney Cancer (CYTOSHRINK Trial)

Phase 2

Waitlist Available

Led By Aly-Khan Lalani, MD

Research Sponsored by Ontario Clinical Oncology Group (OCOG)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven renal cell carcinoma of any histology

Primary kidney lesion amenable to SBRT

Must not have

Previous abdominal radiation precluding SBRT

Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ipilimumab/nivolumab may cause immune-related side effects like inflammation of organs, skin rash, hormone gland problems (like thyroid), fatigue, and flu-like symptoms. Radiation from SBRT could lead to localized pain or skin changes where the treatment is given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer diagnosis was confirmed with a biopsy.

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My kidney tumor can be treated with targeted radiation.

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My condition is considered intermediate or poor risk.

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I am eligible for standard cancer treatment with ipilimumab and nivolumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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My kidney tumor is 20 cm or larger.

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I need considerable assistance and medical care.

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I have a condition that makes me sensitive to radiation.

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I cannot lie still flat on my back for 30 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Ipilimumab/ Nivolumab drug tolerability

Objective response rate

Overall Survival

+2 more

Other study objectives

Correlation with blood or stool immune signatures

Exploratory Outcomes: Evaluation of baseline and changes during treatment in blood immune signatures

Exploratory Outcomes: Evaluation of baseline and changes during treatment in stool microbiome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care I/N plus primary disease SBRTExperimental Treatment1 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 aloneActive Control1 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.

0 / 11Eligibility criteria met