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Radioactive Agent
177Lu Girentuximab + Cabozantinib + Nivolumab for Advanced Renal Cell Carcinoma
Phase 1 & 2
Waitlist Available
Led By Eric Jonasch, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore if a combination of drugs can help treat advanced ccRCC.
Who is the study for?
This trial is for adults with advanced clear cell renal cell carcinoma who haven't had systemic therapy for metastatic RCC. They must be able to swallow pills, have good organ function, and no major health issues that could affect the trial. Women of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
The study tests if combining 177Lu girentuximab with cabozantinib and nivolumab can control advanced kidney cancer. It's in early stages (Phase 1b/2) to see how well patients respond and what doses are safe.
What are the potential side effects?
Possible side effects include reactions at the injection site, high blood pressure, fatigue, liver enzyme changes, digestive issues like nausea or diarrhea, risk of infections due to immune system effects from nivolumab, and other drug-specific reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 (Biopsy)Experimental Treatment4 Interventions
Participants at the time of progression or at 20 months post treatment
Group II: Cohort 2 (Biopsy)Experimental Treatment4 Interventions
Participants within 2 weeks of Cycle 4
Group III: Cohort 1 (Biopsy)Experimental Treatment4 Interventions
Participants within 2 weeks of starting the first dose of 177Lu-girentuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Cabozantinib
2020
Completed Phase 2
~2360
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,445 Total Patients Enrolled
Telix Pharmaceuticals LimitedUNKNOWN
Eric Jonasch, MDPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nutrient absorption issues due to past GI surgery or disease.I am on long-term medication that affects how drugs are broken down in my body.Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drug.I have not had recent radiation for bone metastases or other radiation treatments that would disqualify me.My brain cancer is under control and not life-threatening, with other measurable disease present.I haven't had a major heart or stroke event in the last 6 months.Your blood counts and organ function are within certain levels and have not required specific treatments within the past 2 weeks.I have fully healed from any major surgery at least 1 month before starting the study drug.I am 18 years old or older.You have a history of an autoimmune disease that needs ongoing treatment.I have received initial treatment for kidney cancer that has spread.I have had spinal cord compression or leptomeningeal disease.My blood pressure is often higher than 140/90, even with medication.I do not have serious wounds, liver issues, need for dialysis, or organ transplants.I agree to use effective birth control during and for 120 days after the study.I can take pills by mouth.I am currently being treated for an infection.My tumor is growing into or around major blood vessels.My kidney cancer is advanced or has spread, and is mainly clear cell type.I have gastrointestinal disorders that could lead to holes or abnormal connections in my GI tract.I have no cancer other than kidney cancer, except for certain skin cancers or cervical cancer that's been treated and I've been cancer-free for over 2 years.You have at least one specific spot that can be measured according to the RECIST version 1.1 guidelines.I am fully active or restricted in physically strenuous activity but can do light work.I can provide a sample of my tumor tissue.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (Biopsy)
- Group 2: Cohort 2 (Biopsy)
- Group 3: Cohort 3 (Biopsy)
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.