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Immunotherapy
Naptumomab + Pembrolizumab for Bladder Cancer
Phase 1
Waitlist Available
Led By Cora Sternberg, M.D.
Research Sponsored by Weill Medical College of Cornell University
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 until disease progression or death, for a maximum of approximately 4 years
Awards & highlights
Study Summary
This trial will test a novel combination of drugs to treat urothelial cancer, as well as their side effects and efficacy.
Who is the study for?
Adults with transitional cell urothelial cancer, which includes cancers of the renal pelvis, ureter, bladder or urethra. They must have advanced or metastatic disease and can have had up to two prior treatments for it. Participants need a life expectancy of at least 12 weeks and should be able to follow the study's schedule. Exclusions include those with certain immune conditions, recent live vaccines, organ transplants, uncontrolled HIV infection, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The trial is testing naptumomab estafenatox (NAP) combined with pembrolizumab after an initial treatment with obinutuzumab in patients with urothelial cancers. The hypothesis is that NAP will boost pembrolizumab's effectiveness against cancer. Treatment involves cycles where NAP is given daily for four days followed by pembrolizumab every three weeks for up to two years.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever or chills; immune-related issues like inflammation in various organs; fatigue; possible increased risk of infections due to immunosuppression; and other drug-specific adverse effects that will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression or death, for a maximum of approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression or death, for a maximum of approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 Dose (RP2D) of the combination of NAP/pembrolizumab preceded by obinutuzumab to find the
Secondary outcome measures
12-Month Progression-Free Survival (12-PFS)
6-month Progression-Free Survival (6-PFS)
Median duration of response (DOR) in subjects who achieve an objective response (CR or PR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Naptumomab estafenatox in combination with pembrolizumab preceded by ObinutuzumabExperimental Treatment3 Interventions
The study will test two doses of NAP 5 µg/kg/day IV (Dose Level 1) and 10 µg/kg/day IV (Dose Level 2), in combination with a fixed dose of pembrolizumab (200mg IV every 3 weeks). NAP will be given on Days 1-4 of each 21 day cycle for 6 cycles. Pembrolizumab will be given on Day 2 of each 21-day treatment cycle for the first 6 cycles and then as monotherapy every 21 days for up to a total of 34 administrations. Two doses of Obinutuzumab 1,000 mg IV will be given before starting NAP and pembrolizumab on Days - 13 and -12.
Pembro 200 mg i.v. Day 2 of each 21-day treatment cycle for the first 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,528 Total Patients Enrolled
NeoTX Therapeutics Ltd.Industry Sponsor
2 Previous Clinical Trials
98 Total Patients Enrolled
Cora Sternberg, M.D.Principal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery or serious injury in the last 4 weeks.I do not have another cancer needing treatment at the same time.I have brain metastases but am stable after treatment.I have not needed treatment for an infection in the last 3 days.I have not had a live vaccine in the last 4 weeks.I am 18 years old or older.My cancer has spread to other parts of my body.My cancer is mainly urothelial and has been confirmed by tests.I have or had an autoimmune or inflammatory disorder, but it's not vitiligo, psoriasis without recent treatment, stable endocrinopathies, primary immunodeficiency, or a history of organ transplant.I have previously been treated with NAP, pembro, or Obi.I've had at most 2 treatments for my advanced cancer, but may have had additional therapy before these.My HIV is not well-controlled.I have had progressive multifocal leukoencephalopathy in the past.I have completed the initial COVID-19 vaccine series and it's been 2 weeks since my last dose.I haven't taken strong immune system drugs in the last 28 days.I do not have severe heart or blood vessel conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Naptumomab estafenatox in combination with pembrolizumab preceded by Obinutuzumab
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.
Is registration still open for the trial at this time?
"Clinicaltrials.gov confirms that this trial, first advertised on June 1st 2023 and last edited May 30th 2023, is not recruiting any longer; however there are currently 210 clinical studies actively enrolling participants."
Answered by AI
Has the federal government sanctioned the pairing of Naptumomab estafenatox and pembrolizumab with Obinutuzumab?
"Our experts at Power have given Naptumomab estafenatox in combination with pembrolizumab preceded by Obinutuzumab a score of 1 due to the limited evidence supporting its safety and efficacy."
Answered by AI
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