Neoadjuvant Immunotherapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

+2 other locations

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

My organs are functioning well.

Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception

I am fully active or can carry out light work.

+7 more

Exclusion Criteria

I may need to start medications that affect my immune system during the study.

You have an ongoing autoimmune disease, except for certain specific conditions.

Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

+13 more

Participant Groups

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).