104 Participants Needed

Immunotherapy for Kidney Cancer

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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

What is the purpose of this trial?

This randomized pilot early phase I trial studies the side effects and how well nivolumab alone works compared to nivolumab with bevacizumab or ipilimumab before surgery in treating patients with kidney cancer, also referred to as renal cell cancer, that has spread to another place in body and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, bevacizumab, and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, patients on high-dose steroids or other potent immune suppression medications, as well as those requiring ongoing anticoagulation (except aspirin), are excluded. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Nivolumab for kidney cancer?

Research shows that Nivolumab, a drug that helps the immune system fight cancer, improved survival in patients with advanced kidney cancer compared to another treatment called everolimus.12345

What safety data exists for immunotherapy treatments like Nivolumab and Ipilimumab in kidney cancer?

Immunotherapy treatments like Nivolumab and Ipilimumab can cause immune-related side effects, which may affect various organs. Common side effects include inflammation of the colon, liver, skin, and thyroid, while rare but serious effects can include heart and lung inflammation. These treatments have been studied in kidney cancer and other conditions, showing a need for careful monitoring of these side effects.678910

How is the drug Nivolumab unique in treating kidney cancer?

Nivolumab is unique because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells, specifically targeting the PD-1 pathway. It has shown a survival advantage in patients with advanced kidney cancer who have already received other treatments, offering a new option after anti-angiogenic therapy.411121314

Research Team

PS

Padmanee Sharma, MD, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with metastatic clear cell renal cell carcinoma (kidney cancer) that can be surgically removed. Participants must understand the study and risks, may have had previous treatments except certain immunotherapies or bevacizumab, and should meet specific health criteria like adequate blood counts and organ function.

Inclusion Criteria

My kidney cancer has spread, and I am eligible for surgery to remove the tumor.
I have a tumor or lymph node that can be measured and meets the size requirements.
I have had treatments for kidney cancer but not with PD1 or CTLA-4 inhibitors or bevacizumab.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab alone or in combination with bevacizumab or ipilimumab for 6 weeks, followed by surgery

6 weeks
3 visits (in-person)

Surgery

Patients undergo nephrectomy, metastasectomy, or biopsy approximately 4 weeks after treatment

1 day
1 visit (in-person)

Maintenance Therapy

Patients receive maintenance nivolumab every 4 weeks for up to 2 years if they have a clinical response or stable disease

Up to 2 years
Every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
30 days, 86 days, every 3 months for 2 years, every 6 months for 1 year, then annually

Treatment Details

Interventions

  • Bevacizumab
  • Ipilimumab
  • Nivolumab
Trial Overview The trial tests how well nivolumab works alone or combined with bevacizumab or ipilimumab before surgery in patients with kidney cancer. It's an early phase I pilot study to see if these monoclonal antibodies can boost the immune system to fight cancer and prevent tumor growth.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm C (nivolumab, ipilimumab, surgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1 every 3 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (nivolumab, bevacizumab, surgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 60 minutes and bevacizumab IV over 90 minutes on day 1 every 2 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (nivolumab, surgery)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 60 minutes on day 1 every 2 weeks for 6 weeks. Approximately 4 weeks later, patients undergo nephrectomy, metastasectomy or biopsy. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

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

🇺🇸
Approved in United States as Opdivo for:
  • Advanced or metastatic gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Hepatocellular carcinoma
  • Esophageal squamous cell carcinoma
🇪🇺
Approved in European Union as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
🇨🇦
Approved in Canada as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma
🇨🇭
Approved in Switzerland as Opdivo for:
  • Melanoma
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Hodgkin lymphoma
  • Head and neck squamous cell carcinoma
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Esophageal adenocarcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 91 patients with metastatic renal cell carcinoma (mRCC), nivolumab showed significant improvements in overall survival, with a median survival of 25.2 months for the highest dose (10 mg/kg) and not reached for treatment-naïve patients.
Nivolumab treatment led to substantial increases in tumor-associated lymphocytes and changes in chemokine levels, indicating its immunomodulatory effects, while no new safety concerns were identified.
Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma.Choueiri, TK., Fishman, MN., Escudier, B., et al.[2022]
Nivolumab, an anti-PD-1 antibody, shows promising effects in the treatment of advanced renal cancer, indicating its potential as an effective immunotherapy option.
The manuscript highlights the role of nivolumab in harnessing the immune system to target and combat renal cancer, suggesting a new avenue for treatment in this challenging disease.
[Nivolumab (Anti-PD-1 antibody; ONO-4538/BMS-936558) in renal cancer].Ozono, S.[2018]
A 65-year-old man with advanced renal cell carcinoma achieved a remarkable reduction in metastasis after receiving nivolumab as the fifth systemic therapy, following treatment with angiogenesis inhibitors and interferon-α.
The patient experienced a pathological complete response, with no cancer cells found after adrenalectomy, and remains healthy 20 months post-surgery, highlighting the potential efficacy of nivolumab in advanced renal cell carcinoma cases.
Pathological complete response after nivolumab therapy following angiogenesis inhibitors in a patient with metastatic renal cell carcinoma.Hagimoto, H., Kashima, S., Doi, K., et al.[2022]

References

Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma. [2022]
Nivolumab drug holiday in patients treated for metastatic renal cell carcinoma: A real-world, single-centre experience. [2022]
[Nivolumab (Anti-PD-1 antibody; ONO-4538/BMS-936558) in renal cancer]. [2018]
Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. [2022]
Pathological complete response after nivolumab therapy following angiogenesis inhibitors in a patient with metastatic renal cell carcinoma. [2022]
Tubulointerstitial nephritis as adverse effect of programmed cell death 1 inhibitor, nivolumab, showed distinct histological findings. [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]
Association Between Immune-related Adverse Events and Clinical Outcome Following Nivolumab Treatment in Patients With Metastatic Renal Cell Carcinoma. [2021]
Minimal change disease in a patient receiving checkpoint inhibition: Another possible manifestation of kidney autoimmunity? [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Immune Related Adverse Events: Classification and Management Approaches in Advanced Kidney Cancer. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. [2022]
FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti-Angiogenic Therapy and Exploratory Predictive Biomarker Analysis. [2018]
Nivolumab in the treatment of advanced renal cell carcinoma. [2018]
[Immunotherapy for renal cell carcinoma - current status]. [2019]
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