Neoadjuvant Immunotherapy for Mesothelioma

Palo Alto (17 mi)

Overseen byPatrick Forde, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Stay on your current meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The proposed study will evaluate the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab in resectable MPM. In addition, maintenance nivolumab will be administered for 1 year following completion of standard bi-/tri-modality therapy.

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer is confirmed as epithelial or biphasic mesothelioma.

My tumor can be safely biopsied for this study.

My cancer is in stages I-III and a surgeon believes it can be removed with surgery.

My lung function is good enough for surgery, confirmed by tests.

Exclusion Criteria

I have received cancer treatment before surgery.

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

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.

Treatment Details

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.

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).