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Checkpoint Inhibitor
Rituximab + Hyaluronidase with Immunotherapy for Melanoma
Phase 2
Waitlist Available
Led By Kavita Dhodapkar, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN for patients with documented liver metastases)
Clinically eligible to receive FDA approved standard of care combination immune checkpoint therapy with ipilimumab and nivolumab for unresectable stage III or stage IV melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks and every 12 weeks thereafter up to 1 year
Awards & highlights
Study Summary
This trial looks at whether a two-drug combo can prevent harmful immune reactions in people with advanced melanoma who are also receiving other immunotherapy treatments.
Who is the study for?
This trial is for adults with advanced melanoma that can't be surgically removed, who are about to start treatment with nivolumab and ipilimumab. They must have certain blood test levels within normal ranges and no severe side effects from previous similar treatments. Excluded are those with inflammatory bowel disease, active CNS metastases, hepatitis B or C, HIV, autoimmune disorders like lupus or type I diabetes, or on corticosteroids.Check my eligibility
What is being tested?
The study is testing if Rituxan Hycela (rituximab and hyaluronidase human) can prevent serious immune-related side effects in patients receiving standard care therapy with nivolumab and ipilimumab for unresectable stage III-IV melanoma.See study design
What are the potential side effects?
Possible side effects include allergic reactions to rituximab or its components, potential worsening of infections due to immune system suppression by the drugs being tested. The exact side effect profile will be monitored closely during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within the required range.
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I am eligible for standard melanoma treatment with ipilimumab and nivolumab.
Select...
I haven't had immune checkpoint inhibitor therapy in the last year.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks and every 12 weeks thereafter up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks and every 12 weeks thereafter up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Common Terminology Criteria (CTC) (version [v]5.0) grade 3 or greater immune-related adverse events
Secondary outcome measures
Objective tumor response
Rate of CTC (v5.0) toxicity related to rituximab and hyaluronidase human
Rate of overall survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (rituximab, hyaluronidase human)Experimental Treatment3 Interventions
This includes induction with 4 cycles of ipilimumab and nivolumab X 4 cycles followed by continuation with nivolumab alone every month for 1 year as in standard of care arm. Each induction cycle is 21 days and includes ipilimumab on day 1 plus nivolumab on day 1. In addition, patients will receive 4 weekly doses of Rituxan (first dose intravenously and then 3 weekly doses subcutaneously). First dose of Rituxan will be administered one week following the start of cycle 1 of ipilimumab and nivolumab. All treatments will have a +/-3 business day window for administration.
Group II: Arm A (standard of care)Active Control2 Interventions
This is standard of care arm: induction with 4 cycles (21 days each) of Ipilimumab and nivolumab followed by continuation with nivolumab alone every month X1 year (13 doses).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,517 Total Patients Enrolled
7 Trials studying Melanoma
142 Patients Enrolled for Melanoma
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,674 Total Patients Enrolled
34 Trials studying Melanoma
1,672 Patients Enrolled for Melanoma
Kavita Dhodapkar, MDPrincipal Investigator - Emory University
Emory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within the required range.I am not on steroids for an autoimmune disease.Your LDH blood test result is not more than 10 times the upper limit of normal.My cancer has spread to my brain or spinal cord.I had ipilimumab, nivolumab, or pembrolizumab over a year ago without severe side effects.I have had treatments like immune therapies or vaccines before.I have been treated with interferon in the past.I do not have active hepatitis B or C.I am allergic to rituximab or its components.Your total bilirubin levels should be within a certain range, unless you have a specific condition called Gilbert's syndrome.Your hemoglobin level is at least 9 grams per deciliter.I do not have and have never had inflammatory bowel disease.You have a white blood count of at least 3,000 per microliter.Your alkaline phosphatase level is not too high, unless you have bone metastasis.I am eligible for standard melanoma treatment with ipilimumab and nivolumab.I am not on corticosteroid therapy, except for replacement needs.I haven't had immune checkpoint inhibitor therapy in the last year.I do not have autoimmune disorders like lupus or type I diabetes.Your white blood cell count is at least 1,500 per microliter.Your platelet count is at least 100,000 per microliter.My kidney function, measured by creatinine levels, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (standard of care)
- Group 2: Arm B (rituximab, hyaluronidase human)
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 maladies has Rituximab and Hyaluronidase Human been shown to ameliorate?
"Rituximab and Hyaluronidase Human can be used as treatments for b-cell lymphomas, polyangium, and malignant neoplasms."
Answered by AI
Are people with the qualifying condition able to participate in this research project at this time?
"This trial, which was originally posted on June 5th, 2019 and last updated on June 27th, 2022, is currently looking for participants."
Answered by AI
Are Rituximab and Hyaluronidase Human commonly used in other medical studies?
"Currently, 1232 clinical trials are ongoing which investigate Rituximab and Hyaluronidase Human. Of these studies, 188 are in Phase 3. Wuhan is running out of locations for these types of study however Other has 59793 active sites."
Answered by AI
How many people are the most that can be a part of this research project?
"That is correct, the online information about this clinical trial reveals that it is still recruiting patients. The study was first posted on June 5th, 2019 and has been updated as recently as June 27th, 2022. The aim is to recruit 44 patients from a single location."
Answered by AI
What are the short-term risks associated with taking Rituximab and Hyaluronidase Human?
"There is early clinical data suggesting that Rituximab and Hyaluronidase Human are safe, but no studies have been done to confirm efficacy. Therefore, it received a score of 2."
Answered by AI
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