41 Participants Needed

Nivolumab + 177Lu-girentuximab for Kidney Cancer

Recruiting at 8 trial locations
NP
DF
Overseen ByDarren Feldman, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Anti PD-1 or PD-L1
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment for advanced kidney cancer using a specific protein. The treatment combines a drug that targets cancer cells with another drug that helps the body’s immune system fight the cancer. The goal is to see if this combination is safe and effective.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients on therapeutic anticoagulation should be on a stable dose, which suggests that some medications may be continued. It's best to discuss your specific medications with the trial team.

What makes the drug Nivolumab + 177Lu-girentuximab unique for kidney cancer?

This drug combines Nivolumab, which helps the immune system attack cancer cells, with 177Lu-girentuximab, a targeted therapy that delivers radiation directly to kidney cancer cells by binding to a specific protein (CAIX) on their surface. This dual approach aims to enhance treatment effectiveness by both boosting the immune response and directly targeting cancer cells with radiation.12345

What data supports the effectiveness of the treatment Nivolumab + 177Lu-girentuximab for kidney cancer?

A study on 177Lu-girentuximab showed that it helped stabilize the disease in 9 out of 14 patients with advanced kidney cancer, although some patients experienced significant side effects that limited further treatment.12345

Who Is on the Research Team?

DF

Darren R. Feldman

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced kidney cancer that has clear cell features and the CAIX protein. Participants must have had at least one prior systemic therapy, including an anti PD-1 or PD-L1 antibody, and cannot join if they've had certain treatments recently, have severe allergies to specific antibodies, uncontrolled infections like HIV or hepatitis B/C, untreated brain metastases larger than 1cm or symptomatic of any size, a history of significant cardiovascular disease within the past three months, or are pregnant.

Inclusion Criteria

Lymphocyte count ≥ 500/μL
INR and aPTT ≤ 1.5 x ULN
My platelet count is at least 100,000/μL without recent transfusions.
See 15 more

Exclusion Criteria

I have not had major surgery in the last 4 weeks.
I have brain metastases larger than 1cm or they are causing symptoms.
Exposure to murine or chimeric antibodies within the last 5 years
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Establish the maximal tolerated dose (MTD) of 177Lu-labeled-girentuximab in combination with standard-dose nivolumab using a 3+3 design

24 weeks

Phase 2 Treatment

Participants receive the combination treatment of 177Lu-girentuximab and nivolumab to assess efficacy at the MTD

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-labeled-girentuximab
  • Nivolumab
Trial Overview The study tests whether combining Nivolumab (an immunotherapy drug) with a radioactive drug called 177Lu-girentuximab is safe and works against kidney cancer. Patients will also undergo scans using another substance called 89Zr-girentuximab to see how the tumor responds.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Safety lead-in Phase: Participants with Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCCExperimental Treatment4 Interventions
Group II: Phase 2 ParticipantsExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

The study demonstrated that dual-labeled girentuximab can specifically target clear cell renal cell carcinoma (ccRCC) tissue, allowing for effective visualization of tumors during surgery using both radionuclide and fluorescence imaging techniques.
In a trial involving seven human kidney specimens, the maximum uptake of girentuximab in tumor tissue was significantly higher (up to 0.33% of the injected dose per gram) compared to normal kidney tissue (up to 0.04% ID/g), confirming its potential for precise tumor detection in clinical settings.
Targeted Dual-Modality Imaging in Renal Cell Carcinoma: An Ex Vivo Kidney Perfusion Study.Hekman, MC., Boerman, OC., de Weijert, M., et al.[2018]
The phase I study involving 10 patients showed that [89Zr]Zr-DFO-girentuximab is safe and well tolerated, with no serious treatment-related adverse events reported, indicating its potential for clinical use.
89Zr-girentuximab PET/CT imaging effectively differentiated clear cell renal cell carcinoma (ccRCC) from non-ccRCC lesions in all patients, providing a quantitative assessment of tumor dosimetry, which is crucial for treatment planning.
Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma.Merkx, RIJ., Lobeek, D., Konijnenberg, M., et al.[2022]
In the ARISER trial involving 864 patients with high-risk clear cell renal cell carcinoma (ccRCC), girentuximab did not show a statistically significant improvement in disease-free survival (DFS) or overall survival (OS) compared to placebo, indicating it may not be an effective adjuvant treatment.
Despite the lack of clinical benefit, the study reported a median DFS of 71.4 months for the girentuximab group, suggesting that patients may have longer survival times than expected, which poses challenges for future drug development in this area.
Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial.Chamie, K., Donin, NM., Klöpfer, P., et al.[2022]

Citations

Targeted Dual-Modality Imaging in Renal Cell Carcinoma: An Ex Vivo Kidney Perfusion Study. [2018]
Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma. [2022]
Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial. [2022]
Phase 2 Study of Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma. [2022]
Evaluation of Radiolabeled Girentuximab In Vitro and In Vivo. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security