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Monoclonal Antibodies
Ipi/Nivo + Sacituzumab Govitecan for Bladder Cancer
Phase 1 & 2
Waitlist Available
Led By Rohit K Jain, MD, MPH
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for people with metastatic bladder cancer.
Who is the study for?
Adults with advanced bladder cancer who can't use cisplatin chemotherapy due to certain health issues. They must have a good performance status, no severe heart disease or active infections, and not be pregnant. Men and women must agree to contraception methods.Check my eligibility
What is being tested?
The trial tests Ipilimumab plus Nivolumab (IPI-NIVO) combined with Sacituzumab Govitecan in patients with metastatic bladder cancer. It aims to determine the effectiveness of this drug combination for those ineligible for cisplatin chemotherapy.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive problems like diarrhea or constipation, blood cell count changes increasing infection risk, and potential liver enzyme alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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I cannot have cisplatin chemotherapy due to kidney, hearing, nerve issues, or heart problems.
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My cancer can be measured on scans and has grown in previously treated areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Maximum Tolerated Dose
Phase 2: Overall Response Rate
Secondary outcome measures
Phase 1: Duration of Response (DOR)
Phase 1: Overall Response Rate
Phase 1: Progression Free Survival (PFS)
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Treatment at Maximum Tolerated Dose (MTD)Experimental Treatment3 Interventions
Participants will be treated at with Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks plus the maximum tolerated dose of Sacituzumab Govitecan days 1 and 8 every 3 weeks.
Group II: Phase 1 Dose Level 2Experimental Treatment3 Interventions
Participants will be treated at dose level 2: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 10 mg/kg IV will be administered days 1 and 8 every 3 weeks.
Group III: Phase 1 Dose Level 1Experimental Treatment3 Interventions
Participants will be treated at dose level 1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 8 mg/kg IV will be administered days 1 and 8 every 3 weeks.
Group IV: Phase 1 Dose Level -1Experimental Treatment3 Interventions
If dose reduction is indicated, participants will be treated at dose level -1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 6 mg/kg IV will be administered days 1 and 8 every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Sacituzumab govitecan
2017
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,707 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,446 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,468 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have HIV with a high viral load and take medication that could affect my treatment.I am taking medication that affects ABCA1 transporter or UGT1A1.I have stable brain metastases, not on high-dose steroids, and no carcinomatous meningitis.You have a condition called Gilbert's disease.My lab tests show my organs are working well.I have not received a live vaccine in the last 30 days.My cancer is a mainly urothelial carcinoma and has spread beyond the bladder.I cannot have cisplatin chemotherapy due to kidney, hearing, nerve issues, or heart problems.I haven't taken high doses of steroids in the last 2 weeks, but may be on a stable low dose.I am fully active or can carry out light work.I agree to use reliable birth control during and after the study for the required time.I am 18 years old or older.I am a woman who is either not pregnant, post-menopausal, or have had surgery to remove my ovaries or uterus.I haven't had recent radiation for bone metastasis or other types, and I've recovered from any major surgeries.My cancer can be measured on scans and has grown in previously treated areas.I haven't had serious bleeding, blockage in my intestines, or a hole in my gut in the last 6 months.I do not have an active autoimmune disease needing steroids or immunosuppressants.I had chemotherapy for bladder cancer less than a year ago and may have had immunotherapy if it was over 3 months ago.I have no active cancer besides my current diagnosis or had cancer that's been inactive for 3 years.I do not have active Hepatitis B or C.I have a history of lung scarring or inflammation not caused by infections.I haven't taken antibiotics for an infection in the last 2 weeks, except for prevention.I am not pregnant or breastfeeding.I do not have any ongoing heart problems.My cancer includes a small-cell component.I have previously been treated with sacituzumab govitecan, irinotecan, or a similar drug.I have had chemotherapy for bladder cancer that has spread.I have an ongoing inflammatory bowel condition or a history of bowel blockage.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Level 2
- Group 2: Phase 1 Dose Level -1
- Group 3: Phase 2: Treatment at Maximum Tolerated Dose (MTD)
- Group 4: Phase 1 Dose Level 1
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 previous trials has Sacituzumab govitecan been subjected to?
"In 2009, Sacituzumab govitecan was initially researched at Texas Children's Hospital. Currently there are 367 completed studies and 797 ongoing trials with a large concentration of these clinical investigations taking place in Tampa, Florida."
Answered by AI
What is the intent of this exploration?
"This medical trial's primary objective, assessed over a 12-month period is to identify the Maximum Tolerated Dose. Secondary outcomes gauged by this study include: Overall Response Rate (CR or PR), Progression Free Survival (PFS) and Overall Survival (OS). Data will be collected using Kaplan-Meier estimation for survival until 6 months after terminating treatment; any patient that survives beyond this point will have their data censored."
Answered by AI
What has been the primary purpose of Sacituzumab govitecan treatments?
"Sacituzumab govitecan has demonstrated efficacy in treating various types of cancer, including melanoma and squamous cell carcinoma. This medication can also be used to reduce the risk of recurrence or mitigate disease progression."
Answered by AI
What is the cap on participants for this experiment?
"Affirmative. According to the data hosted on clinicaltrials.gov, this trial is actively attempting to recruit volunteers for participation and was originally posted on April 30th 2021. Currently, 46 individuals are being sought from two different medical facilities."
Answered by AI
Are there any vacancies for prospective participants in this experiment?
"Clinicaltrials.gov states that this trial is seeking new participants, with the first posting on April 30th 2021 and most recent update being October 26th 2022."
Answered by AI
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