Nivolumab + Chemotherapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byMichael Offin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.

Eligibility Criteria

This trial is for adults with resectable malignant pleural mesothelioma. Participants must have a performance status indicating they are relatively active, agree to contraception if of childbearing potential, and not be pregnant or breastfeeding. They should not have had prior chemo or immunotherapy for mesothelioma, no serious illnesses or other cancers requiring treatment, and no active hepatitis B/C or HIV.

Inclusion Criteria

My surgeon believes my condition can be treated with surgery.

I can provide tissue samples for the study, either from previous procedures or by undergoing a new biopsy if safe.

You have a negative HIV blood test.

+10 more

Exclusion Criteria

Pregnant or lactating women

I have received chemotherapy or immunotherapy for mesothelioma.

I currently have lung inflammation.

+4 more

Participant Groups

The study tests the combination of Nivolumab (an immunotherapy drug) with chemotherapy drugs Pemetrexed and either Cisplatin or Carboplatin before surgery in patients with mesothelioma. It aims to determine if this approach is safe and effective without delaying surgical intervention.

1Treatment groups

Experimental Treatment

Group I: nivolumab with pemetrexed and cisplatin or carboplatinExperimental Treatment3 Interventions

Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication.