22 Participants Needed

Nivolumab + Chemotherapy for Mesothelioma

Recruiting at 8 trial locations
MZ
MO
Overseen ByMichael Offin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using prednisone at a dose of 10 mg or more daily, or if you have an autoimmune disease requiring treatment in the past two years.

What safety data exists for the combination of Nivolumab and chemotherapy in treating mesothelioma?

Pemetrexed, when combined with cisplatin or carboplatin, has been studied for safety in treating mesothelioma. Common side effects include low blood cell counts, tiredness, nausea, and vomiting. Patients are advised to take vitamins and steroids to help reduce these side effects.12345

What makes the drug combination of Nivolumab, Cisplatin or Carboplatin, and Pemetrexed unique for treating mesothelioma?

This treatment is unique because it combines Nivolumab, an immunotherapy drug that helps the immune system attack cancer cells, with chemotherapy drugs Cisplatin or Carboplatin and Pemetrexed, which are already known to be effective in treating mesothelioma. The addition of Nivolumab may enhance the overall effectiveness of the treatment by boosting the body's natural defenses against cancer.14567

What data supports the effectiveness of the drug combination Nivolumab + Chemotherapy for Mesothelioma?

Research shows that combining pemetrexed with cisplatin or carboplatin improves survival in mesothelioma patients compared to cisplatin alone. Additionally, nivolumab combined with another drug, ipilimumab, has shown better overall survival in mesothelioma compared to standard treatments.14589

Who Is on the Research Team?

Michael D. Offin, MD - MSK Thoracic ...

Michael Offin

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.
See 9 more

Exclusion Criteria

Pregnant or lactating women
I have received chemotherapy or immunotherapy for mesothelioma.
I currently have lung inflammation.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants receive two cycles of neoadjuvant therapy with nivolumab, pemetrexed, and either cisplatin or carboplatin

6 weeks

Surgery

Participants undergo pleurectomy/decortication

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin or Carboplatin
  • Nivolumab
  • Pemetrexed
  • Surgery
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: nivolumab with pemetrexed and cisplatin or carboplatinExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

In a study of 51 patients with malignant pleural mesothelioma, both pemetrexed with carboplatin (AC) and pemetrexed with cisplatin (AP) were found to be effective neoadjuvant chemotherapy regimens, with similar rates of disease control and surgical resection (81% for AC and 79% for AP).
However, the AP regimen was associated with a higher incidence of severe side effects, such as grade 3 anemia and increased fatigue, which could negatively affect patients' overall health and their ability to undergo surgery.
Pemetrexed plus carboplatin or cisplatin as neoadjuvant treatment of operable malignant pleural mesothelioma (MPM).Pasello, G., Marulli, G., Polo, V., et al.[2015]
Pemetrexed, often combined with cisplatin or carboplatin, is the most widely studied treatment for malignant pleural mesothelioma (MPM) in Europe, with around 1500 patients enrolled in an Extended Access Program, showing improved survival rates compared to other treatments.
The largest randomized trial indicated that combining pemetrexed with cisplatin improved median survival from 9.3 to 12.1 months, highlighting its efficacy in treating MPM.
Overview on ongoing or planned clinical trials in Europe.Favaretto, A.[2015]
In a study of 146 patients with malignant pleural mesothelioma, the combination of cis/carboplatin plus gemcitabine showed similar median survival rates (11.0 months) compared to cis/carboplatin plus pemetrexed (12.0 months), indicating that both treatment regimens are comparably effective.
Both treatment combinations were well tolerated with similar side effects, suggesting that cis/carboplatin plus gemcitabine is a safe alternative for patients, warranting further investigation in larger randomized trials.
The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma.Ak, G., Metintas, S., Akarsu, M., et al.[2022]

Citations

Pemetrexed plus carboplatin or cisplatin as neoadjuvant treatment of operable malignant pleural mesothelioma (MPM). [2015]
Overview on ongoing or planned clinical trials in Europe. [2015]
The effectiveness and safety of platinum-based pemetrexed and platinum-based gemcitabine treatment in patients with malignant pleural mesothelioma. [2022]
Current treatments for inoperable mesothelioma: indirect comparisons based on individual patient data reconstructed retrospectively from 4 trials. [2023]
Single-agent pemetrexed for chemonaïve and pretreated patients with malignant pleural mesothelioma: results of an International Expanded Access Program. [2015]
FDA drug approval summaries: pemetrexed (Alimta). [2022]
Safety and effectiveness of pemetrexed in patients with malignant pleural mesothelioma based on all-case drug-registry study. [2015]
Carboplatin and pemetrexed in the management of malignant pleural mesothelioma: a realistic treatment option? [2015]
[Mesothelioma: advances in chemotherapy]. [2007]
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