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Cancer Vaccine
Nivolumab + 177Lu-girentuximab for Kidney Cancer
Phase 2
Recruiting
Led By Darren Feldman, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
KPS ≥ 70
At least one prior line of systemic therapy, including at least one prior treatment with anti PD-1 or PD-L1 antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 (+/- 2) weeks
Awards & highlights
Study Summary
This trial is testing a new combo therapy to see if it's safe and effective for treating advanced kidney cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions to treatment components, immune system-related issues affecting organs due to Nivolumab's action on the immune system; radiation-related side effects from the radioactive drugs may include nausea and damage to surrounding tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself.
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I have had treatment before, including a therapy targeting PD-1 or PD-L1.
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I am 18 years old or older.
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I have a detectable cancer spread that can be measured on a special PET/CT scan.
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My kidney cancer is advanced, cannot be surgically removed, and shows clear cell features or CAIX expression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 (+/- 2) weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 (+/- 2) weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal tolerated dose (MTD) of 177Lu-girentuximab
Overall Response Rate/ORR
Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety lead-in Phase: Participants with Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCCExperimental Treatment4 Interventions
Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. The protocol will start with a safety-lead in phase using a 3+3 design to establish the maximal tolerated dose (MTD) of 177Lu-labeled-girentuximab in combination with standard-dose nivolumab. The initial starting dose of 177Lu-labeled-girentuximab is 1804 MBq/m2 which is 75% of the single agent dose established in prior studies and will proceed as shown in the schema below. Once the MTD is established, a Simon two-stage optimal design will commence. 10 patients will be enrolled in the first stage and if no responses are observed, the study will be terminated. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.
Group II: Phase 2 ParticipantsExperimental Treatment4 Interventions
Participants have Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC. If 1 or more responses are observed in the first 10 patients, we will extend enrollment to a total of 29 patients (19 additional patients) in the second stage.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,814 Total Patients Enrolled
Darren Feldman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My platelet count is at least 100,000/μL without recent transfusions.I am mostly able to care for myself.My liver and bone enzymes are within acceptable limits, even with my cancer spread.My hemoglobin level is at least 9.0 g/dL, possibly after treatment.My overall health is good and my organs are functioning well.I have had treatment before, including a therapy targeting PD-1 or PD-L1.My kidneys are working well enough (creatinine clearance ≥ 40mL/min).I have not had major surgery in the last 4 weeks.I have brain metastases larger than 1cm or they are causing symptoms.I have not had significant blood vessel problems in the last 6 months.I haven't had cancer treatment in the last 2 weeks.I have been treated with 177Lu-girentuximab before.I have an active or chronic hepatitis B or C infection.I have untreated cancer spread to my spinal cord or around my brain.My pain is not well-managed and I don't have a stable pain control plan.I am allergic to girentuximab or DFO.My HIV is not well-controlled despite treatment.I am 18 years old or older.I stopped checkpoint inhibitor therapy because of side effects.I cannot receive nivolumab treatment for any reason.I haven't had any radionuclide treatment recently.I need help with feeding or hydration due to stomach or bowel problems.I do not have serious heart problems like recent heart attacks or unstable heart conditions.My heart condition is stable and under control according to my doctor.I can provide tissue samples from a previous biopsy or surgery for cancer diagnosis.I have not had a stroke or mini-stroke in the last 6 months.My tumor sample can be from kidney removal or a metastatic site.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I have a detectable cancer spread that can be measured on a special PET/CT scan.My kidney cancer does not show clear cell features, or is unclassified but with clear cell features.I haven't needed more than 10 mg of prednisone daily for autoimmune issues in the last 2 years.My kidney cancer is advanced, cannot be surgically removed, and shows clear cell features or CAIX expression.I haven't had cancer other than kidney cancer in the last 3 years, or if I did, it was not serious and was treated successfully.I haven't had radiotherapy for kidney cancer in the last 14 days, except for a single session for pain control.I will use two forms of birth control for 6 months after treatment.I have high calcium levels in my blood that require treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Safety lead-in Phase: Participants with Advanced or Metastatic Clear Cell Renal Cell Carcinoma/RCC
- Group 2: Phase 2 Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential perils should be taken into account when administering 177Lu-labeled-girentuximab to patients?
"Our team gave 177Lu-labeled-girentuximab a rating of 2 because this is still in the Phase 2 stage. This means there are preliminary clinical studies that suggest safety, but no evidence supporting efficacy yet."
Answered by AI
In which areas is the clinical trial being managed?
"A total of 7 clinical trial sites are currently enrolling patients, with notable locations like Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge and Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown. Additionally, there are four other institutes participating in the study."
Answered by AI
What is the enrollment capacity for this research endeavor?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which was initially made available on February 16th 2022, is actively recruiting participants. To date, 29 patients are needed at 7 different medical centres."
Answered by AI
Are there any vacancies remaining for potential participants in this research program?
"Per clinicaltrials.gov, this research is currently in the process of recruiting participants having been posted on February 16th 2022 and receiving its most recent update on the same date."
Answered by AI
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