Subcutaneous vs Intravenous Nivolumab for Kidney Cancer
(CheckMate-67T Trial)
Recruiting in Palo Alto (17 mi)
+233 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bristol-Myers Squibb
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are HIV-positive, you must continue your antiretroviral therapy while participating in the study.
What data supports the effectiveness of the drug Nivolumab for kidney cancer?
Research shows that Nivolumab, when used alone or in combination with other drugs, improves survival and response rates in patients with advanced kidney cancer compared to other treatments. It also tends to have fewer side effects, making it a promising option for treating this condition.
12345Is Nivolumab safe for humans?
Nivolumab, also known as Opdivo, has been associated with some immune-related side effects, such as lung inflammation and kidney issues, but these are generally manageable. In patients on hemodialysis, it has been used safely, although careful monitoring is recommended.
678910What makes the drug Nivolumab unique for kidney cancer treatment?
Nivolumab is unique for kidney cancer treatment because it can be administered both subcutaneously (under the skin) and intravenously (into a vein), offering flexibility in how patients receive the drug. This is different from many other treatments that are typically given only one way.
111121314Eligibility Criteria
This trial is for adults with advanced or metastatic clear cell renal cell carcinoma who've had no more than two prior treatments. They must have a Karnofsky performance status of at least 70, measurable disease by RECIST v1.1, and agree to use contraception if needed. Exclusions include untreated brain metastases, active autoimmune diseases, certain HIV conditions, recent live vaccines, other cancers within 2 years, and previous treatment with specific immune-targeting drugs.Inclusion Criteria
My last cancer treatment didn’t work or caused side effects, and it was within the last 6 months.
My kidney cancer cannot be cured with surgery or radiation, or it has spread to other parts.
My kidney cancer has been confirmed to have clear cell features, possibly with sarcomatoid traits.
+4 more
Exclusion Criteria
I haven't had a serious illness like COVID-19 in the last month.
I am HIV positive but have been on ART for at least 4 weeks and will continue treatment.
I have an autoimmune disease.
+5 more
Participant Groups
The study compares the levels and effects of Nivolumab when given as a subcutaneous injection (under the skin) versus intravenously (into a vein). Participants will be randomly assigned to one of these methods to assess drug efficacy and safety in those previously treated for kidney cancer that has spread.
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm DExperimental Treatment1 Intervention
Group II: Arm CExperimental Treatment1 Intervention
Group III: Arm AExperimental Treatment1 Intervention
Group IV: Arm BActive Control1 Intervention
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
Research Locations NearbySelect from list below to view details:
Local InstitutionWest Reading, PA
Reading Hospital McGlinn Cancer InstituteWest Reading, PA
Roswell Park Cancer InstituteBuffalo, NY
Local Institution - 0088West Reading, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Bristol-Myers SquibbLead Sponsor
References
Checkpoint Inhibitor Combo Effective for RCC. [2019]In a phase III trial, the combination of nivolumab and ipilimumab yielded more and longer responses than sunitinib in patients with renal cell carcinoma at intermediate or high risk of progression. More than 41% of patients who received the immunotherapy combination responded, compared with 26.5% of patients who received sunitinib. Patients receiving the combination also experienced longer progression-free survival and fewer side effects.
Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma. [2022]Nivolumab, an anti-PD-1 immune checkpoint inhibitor, improved overall survival versus everolimus in a phase 3 trial of previously treated patients with metastatic renal cell carcinoma (mRCC). We investigated immunomodulatory activity of nivolumab in a hypothesis-generating prospective mRCC trial.
Pathological complete response after nivolumab therapy following angiogenesis inhibitors in a patient with metastatic renal cell carcinoma. [2022]Nivolumab is effective for advanced renal cell carcinoma; however, reports are limited wherein nivolumab is combined with sequential therapy of angiogenesis inhibitors and metastasectomy.
Efficacy and Safety of Nivolumab for Advanced Renal Cell Carcinoma: A Systematic Review and Meta-Analysis. [2022]To assess the efficacy and safety of nivolumab for advanced renal cell carcinoma (RCC) via meta-analysis.
Negative prognostic factors and resulting clinical outcome in patients with metastatic renal cell carcinoma included in the Italian nivolumab-expanded access program. [2018]We report the outcomes observed with nivolumab in metastatic renal cell carcinoma patients with poor prognostic features enrolled in the Italian expanded access program.
Rapidly progressing programmed cell death 1 inhibitor-related pneumonitis in a hemodialytic patient with metastatic renal cell carcinoma. [2022]The efficacy and safety of nivolumab for patients receiving hemodialysis remain uncertain. Herein, we report a patient receiving a maintenance hemodialysis with life-threatening interstitial pneumonitis caused by nivolumab for metastatic renal cell carcinoma.
Nivolumab and ipilimumab immunotherapy for hemodialysis patients with advanced renal cell carcinoma. [2023]Combined immune checkpoint blockade with nivolumab and ipilimumab is standard therapy for the treatment of patients with previously untreated advanced renal cell carcinoma who are at intermediate or poor risk. However, data about the safety and efficacy of combined immune checkpoint blockade with nivolumab and ipilimumab in patients on hemodialysis are limited. Renal function has no known clinically important effects on the pharmacokinetics and clearance of nivolumab and ipilimumab. Further, most immune-related adverse events in patients on hemodialysis are thought to be manageable with the same treatments applied in patients with normal renal function. We present a case of advanced clear-cell renal cell carcinoma in a patient on hemodialysis who received combined immune checkpoint blockade with nivolumab and ipilimumab and who showed no evident signs of immune-related adverse events. Here, we confirm the safety and efficacy of combined immune checkpoint blockade with nivolumab and ipilimumab in a patient on hemodialysis.
Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab. [2023]Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big dataset.
Immune-related adverse events are clinical biomarkers to predict favorable outcomes in advanced renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]Immune checkpoint inhibitors cause various immune-related adverse events. The present study examined the association between the incidence of immune-related adverse events and survival outcomes in patients treated with nivolumab plus ipilimumab for patients with advanced renal cell carcinoma. In addition, we compared the effect of adverse event profiles on survival for patients receiving nivolumab plus ipilimumab.
Minimal change disease in a patient receiving checkpoint inhibition: Another possible manifestation of kidney autoimmunity? [2021]Nivolumab has been associated with immune-related adverse events, including nephritis, with acute interstitial nephritis being the most commonly reported renal manifestation.
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma. [2021]On the 15 November 2018, the Committee for Medicinal Products for Human Use adopted an extension to an existing indication for the use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). The approval was based on results from the Pivotal CA209214 study, a randomised, open-label, phase III study, comparing nivolumab +ipilimumab with sunitinib in subjects≥18 years of age with previously untreated advanced RCC (not amenable for surgery or radiotherapy) or metastatic RCC, with a clear-cell component. A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either nivolumab (n=425) in combination with ipilimumab administered every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n=422) administered orally for 4 weeks followed by 2 weeks off, every cycle. A statistically significant difference in overall survival (OS) was observed in the nivolumab + ipilimumab group compared with the sunitinib group in intermediate/poor-risk subjects (HR 0.63 (99.8% CI 0.44 to 0.89); stratified log-rank 2-sided p-value
Complete response of metastatic renal cell carcinoma with inferior vena cava tumor thrombus to nivolumab plus ipilimumab. [2022]The effectiveness of nivolumab plus ipilimumab for metastatic renal cell carcinoma with inferior vena cava tumor thrombus remains unclear.
Therapeutic role of deferred cytoreductive nephrectomy in patients with metastatic renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]To explore the therapeutic role of deferred cytoreductive nephrectomy in patients with metastatic renal cell carcinoma treated with nivolumab plus ipilimumab.
First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. [2023]We present an exploratory post hoc analysis from the phase 3 CheckMate 214 trial of first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in a subgroup of 108 patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor, a population under-represented in clinical trials. Patients with clear cell aRCC were randomized to NIVO+IPI every 3 wk for four doses followed by NIVO monotherapy, or sunitinib every day for 4 wk (6-wk cycle). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and primary tumor shrinkage were assessed. PFS and ORR were assessed per independent radiology review committee using RECIST version 1.1. With minimum study follow-up of 4 yr for intent-to-treat patients, OS favored NIVO+IPI (n = 53) over sunitinib (n = 55; hazard ratio 0.63, 95% confidence interval 0.40-1.0) among patients without prior nephrectomy. ORR was higher (34% vs 15%; p = 0.0041) and median duration of response was longer with NIVO+IPI versus sunitinib (20.5 vs 14.1 mo); the best overall response was partial response in either arm. A ≥30% reduction in the diameter of intact target renal tumors was achieved in 35% of patients with NIVO+IPI versus 20% with sunitinib. Safety was consistent with the global study population. In conclusion, in patients with aRCC without prior nephrectomy and with an evaluable primary tumor, NIVO+IPI showed survival benefits and renal tumor reduction versus sunitinib. This trial is registered at ClinicalTrials.gov as NCT02231749. PATIENT SUMMARY: In an exploratory analysis of a large global trial (CheckMate 214), we observed positive outcomes (both survival and tumor response to treatment) with nivolumab plus ipilimumab over sunitinib in a subgroup of patients with advanced kidney cancer who did not undergo removal of their primary kidney tumor. This subset of patients represents a population that has not been studied in clinical trials and for whom outcomes with new immunotherapy combination regimens are not yet known. We conclude that treatment with nivolumab plus ipilimumab offers these patients a survival benefit versus sunitinib, consistent with that observed in the overall study, as well as a notable kidney tumor reduction.