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Neoadjuvant Immunotherapy for Mesothelioma

Phase 2

Waitlist Available

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

Must not have

Administration of chemotherapy or any other cancer therapy in the pre-operative period

Men with female partners (WOCBP) that are unwilling to use contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received cancer treatment before surgery.

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My partner and I are not willing to use birth control.

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I have previously been treated with specific antibodies.

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My cancer is purely sarcomatoid in nature.

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I have had lung problems that made it hard for me to breathe.

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I have tested positive for HIV/AIDS.

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I do not have an active infection needing treatment or hepatitis B/C.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have another active cancer besides mesothelioma.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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