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Neoadjuvant Immunotherapy for Mesothelioma
Phase 2
Recruiting
Led By Patrick Forde, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Histology proven epithelial or biphasic MPM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test a new cancer treatment involving two immunotherapy drugs given before surgery, and one drug given for a year after surgery.
Who is the study for?
This trial is for adults with resectable malignant pleural mesothelioma (MPM), specifically epithelial or biphasic types, who are in good physical condition and have not received prior cancer therapy. They must be able to undergo a biopsy, have adequate organ function, and agree to use contraception. People with unresectable disease, sarcomatoid histology, interstitial lung disease, autoimmune diseases, infections like HIV/AIDS or hepatitis B/C, recent immunosuppressant use or allergies to study drugs cannot join.Check my eligibility
What is being tested?
The trial tests the safety of using Nivolumab alone or combined with Ipilimumab before surgery in MPM patients. After standard treatments post-surgery, maintenance doses of Nivolumab will continue for one year to see if it helps keep the cancer from coming back.See study design
What are the potential side effects?
Nivolumab and Ipilimumab can cause immune-related side effects such as inflammation in various organs including the lungs and intestines; skin reactions; hormone gland problems; fatigue; infusion reactions; and may increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is confirmed as epithelial or biphasic mesothelioma.
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My tumor can be safely biopsied for this study.
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My cancer is in stages I-III and a surgeon believes it can be removed with surgery.
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My lung function is good enough for surgery, confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of neoadjuvant nivolumab +/- ipilimumab in patients with resectable MPM who complete of neoadjuvant treatment and proceed to surgery
Safety Profile of neoadjuvant nivolumab +/- ipilimumab in patients with resectable malignant pleural mesothelioma (MPM) with grade III/IV adverse events defined by CTCAE v5.0
Secondary outcome measures
Pathological Response to neoadjuvant nivolumab +/- ipilimumab in resected tumor and lymph nodes in patients with resectable MPM defined as ≤10% residual viable tumor cells and pathologic complete response
Radiographic Response to neoadjuvant nivolumab +/- ipilimumab utilizing RECIST 1.1
Toxicity as assessed by number of participants experienced grade III/IV adverse events as defined by CTCAE v5.0 within 100 days of last study drug administration
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B Nivolumab + IpilimumabExperimental Treatment2 Interventions
Receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
Group II: Arm A Nivolumab OnlyExperimental Treatment1 Intervention
Receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab Injection
2017
Completed Phase 2
~410
Ipilimumab Injection
2019
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,890 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,434 Total Patients Enrolled
14 Trials studying Mesothelioma
1,914 Patients Enrolled for Mesothelioma
Patrick Forde, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
5 Previous Clinical Trials
1,567 Total Patients Enrolled
2 Trials studying Mesothelioma
269 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I am fully active or can carry out light work.I may need to start medications that affect my immune system during the study.I understand the study, its risks, and I'm willing to sign the consent form.You have an ongoing autoimmune disease, except for certain specific conditions.My cancer is confirmed as epithelial or biphasic mesothelioma.My tumor can be safely biopsied for this study.I am 18 years old or older.I have received cancer treatment before surgery.My partner and I are not willing to use birth control.My cancer is in stages I-III and cannot be removed by surgery.You are in prison or are being held against your will for psychiatric or physical illness treatment.My cancer is in stages I-III and a surgeon believes it can be removed with surgery.I have previously been treated with specific antibodies.My cancer is purely sarcomatoid in nature.I have had lung problems that made it hard for me to breathe.I have tested positive for HIV/AIDS.I do not have an active infection needing treatment or hepatitis B/C.I haven't taken steroids or immunosuppressants in the last 14 days.I have another active cancer besides mesothelioma.I am not pregnant or nursing.My lung function is good enough for surgery, confirmed by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Nivolumab Only
- Group 2: Arm B Nivolumab + Ipilimumab
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 is the aggregate size of the population involved in this clinical experiment?
"Affirmative. Clinicaltrials.gov provides information that indicates this trial is presently enrolling new participants, with the first posting date being October 2nd 2019 and last updated July 20th 2022. This research team seeks to enlist 30 individuals from 3 distinct sites."
Answered by AI
What conditions does Nivolumab Injection typically address?
"Nivolumab Injection is a traditional choice for anti-angiogenic therapy. However, this medication may also be beneficial to patients who suffer from malignant neoplasms, unresectable melanoma and squamous cell carcinoma."
Answered by AI
What other experiments have been conducted concerning Nivolumab Injection?
"Nivolumab Injection was first tested in 2009 at the Texas Children's Hospital. This drug has since been studied extensively and 363 trials have already concluded, with another 765 currently underway - many of which are located within Baltimore, Maryland."
Answered by AI
Are there any available slots open for participants in this scientific trial?
"Per the information on clinicaltrials.gov, this trial is actively searching for participants. It was originally published on October 2nd 2019 and most recently modified on July 20th 2022."
Answered by AI
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