66 Participants Needed

SBRT + Immunotherapy for Kidney Cancer

(CYTOSHRINK Trial)

Recruiting at 7 trial locations
EM
LR
Overseen ByLisa Rudd-Scott, RN BScN MN
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Ontario Clinical Oncology Group (OCOG)
Must be taking: Ipilimumab, Nivolumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on chronic corticosteroids or immune suppressive therapy, except for certain low-dose or topical forms. It also excludes those using medicinal herbal preparations unless prescribed by a doctor.

What data supports the effectiveness of the treatment SBRT + Immunotherapy for Kidney Cancer?

Research shows that the combination of nivolumab and ipilimumab, which are part of the immunotherapy treatment, has been effective in treating advanced kidney cancer, producing positive responses in patients. Additionally, combining radiotherapy with immunotherapy may enhance the treatment's effectiveness.12345

Is the combination of SBRT and immunotherapy safe for kidney cancer patients?

The combination of nivolumab and ipilimumab, which are types of immunotherapy, can cause immune-related side effects like colitis (inflammation of the colon), hepatitis (liver inflammation), dermatitis (skin inflammation), and thyroiditis (thyroid inflammation). Rare but serious side effects include myocarditis (heart inflammation) and pneumonitis (lung inflammation). These side effects are important to monitor and manage during treatment.678910

How is the SBRT + Ipilimumab/Nivolumab treatment different for kidney cancer?

The combination of stereotactic body radiotherapy (SBRT) with the immunotherapy drugs Ipilimumab and Nivolumab is unique because it aims to enhance the immune system's ability to fight kidney cancer by potentially overcoming resistance to immunotherapy. This approach uses SBRT to improve drug delivery and activate antitumor immune cells, which may lead to better outcomes compared to using immunotherapy alone.311121314

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

AL

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.
See 2 more

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.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Induction ipilimumab combined with nivolumab every 3 weeks for cycles 1-4

12 weeks
4 visits (in-person)

Radiation (Experimental Arm)

SBRT to the primary disease in-situ, delivered between cycles 1 and 2 of I/N

1.5 weeks
5 visits (in-person)

Maintenance Treatment

Nivolumab maintenance treatment every 2 or 4 weeks until disease progression or intolerance

Until disease progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Clinic visits every 3 months for 1 year, then at 18 and 24 months

Treatment Details

Interventions

  • Ipilimumab/Nivolumab
  • SBRT
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
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.

Ipilimumab/Nivolumab is already approved in United States, European Union, Japan, Canada for the following indications:

🇺🇸
Approved in United States as Yervoy/Opdivo for:
  • Melanoma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Cancer (MSI-H or dMMR)
🇪🇺
Approved in European Union as Yervoy/Opdivo for:
  • Melanoma
  • Non-Small Cell Lung Cancer (NSCLC)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Cancer (MSI-H or dMMR)
🇯🇵
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)

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Findings from Research

In a phase 3 trial involving 1096 patients with untreated advanced renal-cell carcinoma, nivolumab plus ipilimumab significantly improved overall survival rates (75% at 18 months) compared to sunitinib (60% at 18 months), indicating a more effective treatment option for patients with intermediate or poor prognostic risk.
The objective response rate was also higher with nivolumab plus ipilimumab (42%) compared to sunitinib (27%), although both treatments had a high incidence of treatment-related adverse events, with nivolumab plus ipilimumab showing a slightly lower rate of severe (grade 3 or 4) events (46% vs. 63%).
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma.Motzer, RJ., Tannir, NM., McDermott, DF., et al.[2022]
In a study of 45 Japanese patients with untreated metastatic renal cell carcinoma, the combination therapy of nivolumab and ipilimumab showed a 41.5% objective response rate and a median progression-free survival of 17.8 months over a 2-year follow-up period.
The 2-year analysis indicated that nivolumab plus ipilimumab therapy's effectiveness aligns with previous studies, and second-line therapy following this combination also demonstrated a 20% objective response rate with a median progression-free survival of 9.8 months.
Real-world effectiveness of nivolumab plus ipilimumab and second-line therapy in Japanese untreated patients with metastatic renal cell carcinoma: 2-year analysis from a multicenter retrospective clinical study (J-cardinal study).Kojima, T., Kato, R., Sazuka, T., et al.[2022]
In a study of 74 patients with metastatic renal cell carcinoma, adding stereotactic body radiotherapy (SBRT) to non-first-line PD-1 inhibitors and targeted agents significantly improved overall survival, with a median of 38.5 months compared to 15.4 months for those receiving only anti-PD-1/TA therapy.
The combination of SBRT with anti-PD-1/TA therapy was found to be safe and tolerable, with a similar rate of severe toxicities (54.8% in the SBRT group vs. 65.6% in the anti-PD-1/TA alone group), suggesting that this approach could be beneficial for patients, especially those with clear-cell type renal cancer.
Stereotactic body radiotherapy in combination with non-frontline PD-1 inhibitors and targeted agents in metastatic renal cell carcinoma.Liu, Y., Zhang, Z., Liu, R., et al.[2023]

References

Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. [2022]
Real-world effectiveness of nivolumab plus ipilimumab and second-line therapy in Japanese untreated patients with metastatic renal cell carcinoma: 2-year analysis from a multicenter retrospective clinical study (J-cardinal study). [2022]
Stereotactic body radiotherapy in combination with non-frontline PD-1 inhibitors and targeted agents in metastatic renal cell carcinoma. [2023]
Tailored immunotherapy approach with nivolumab with or without nivolumab plus ipilimumab as immunotherapeutic boost in patients with metastatic renal cell carcinoma (TITAN-RCC): a multicentre, single-arm, phase 2 trial. [2023]
Efficacy and safety of first-line nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma: A multicenter retrospective study. [2021]
Prognostic Impact of Immune-Related Adverse Events as First-Line Therapy for Metastatic Renal Cell Carcinoma Treated With Nivolumab Plus Ipilimumab: A Multicenter Retrospective Study. [2023]
Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab. [2023]
Comparison of the Impact of Immune-Related Adverse Events Due to Immune Checkpoint Inhibitor Dual Combination Therapy and Immune Checkpoint Inhibitor Plus Tyrosine Kinase Inhibitor Combination Therapy in Patients with Advanced Renal Cell Carcinoma. [2023]
Immune Related Adverse Events: Classification and Management Approaches in Advanced Kidney Cancer. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Prognostic impact of immune-related adverse events in metastatic renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A rapid and systemic complete response to stereotactic body radiation therapy and pembrolizumab in a patient with metastatic renal cell carcinoma. [2020]
Survival After Combining Stereotactic Body Radiation Therapy and Tyrosine Kinase Inhibitors in Patients With Metastatic Renal Cell Carcinoma. [2022]
Cytoreductive stereotactic body radiotherapy (SBRT) and combination SBRT with immune checkpoint inhibitors in metastatic renal cell carcinoma. [2021]
Combination with Stereotactic Body Radiotherapy Offers a Promising Strategy to Overcome Resistance to Immunotherapy in Advanced Renal Cell Cancer. [2020]
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