Your session is about to expire
← Back to Search
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 through study completion; an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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
2014
Completed Phase 3
~4750
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,374 Total Patients Enrolled
Telix Pharmaceuticals LimitedUNKNOWN
Eric Jonasch, MDPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
352 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the Biopsy Cohort 1 of this trial have Food and Drug Administration approval?
"The safety of Cohort 1 (Biopsy) was evaluated as a 2 on our assessment scale due to the Phase 2 trial status, which implies some evidence has been collected supporting security but no data yet verifying efficacy."
Answered by AI
Does this investigation have open slots for new participants?
"Based on the clinicaltrials.gov records, this investigation is no longer enrolling patients. The study was initialled posted on May 30th 2023 and edited for the last time on December 15th 2022; however, 498 other trials are actively looking for participants now."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger