Malignant mesothelioma clinical trial combines immunotherapy drugs

Our plain-English summary of Malignant mesothelioma clinical trial combines immunotherapy drugs, by M.S. Chatwal, T. Tanvetyanon (Immunotherapy, 2018).

The study

• Authors: M.S. Chatwal, T. Tanvetyanon
• Journal: Immunotherapy
• Published: 2018;10(5):341-344
• Type of article: Editorial
• Cited by: 4 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Immunotherapy by checkpoint inhibitor is effective for a number of solid tumors including malignant mesothelioma. Studies utilizing single-agent PD-1 or PD-L1 inhibitor for mesothelioma have reported tumor response rates in approximately 10-20% of patients treated. Given the success of combining these agents with CTLA-4 inhibitor in melanoma, there is a strong rationale to study it in mesothelioma. Recently results from clinical trials investigating this approach have been released. Though limited by small sample size, the studies conclusively demonstrated feasibility and suggested a modestly higher tumor response rate than one would expect from treatment with single-agent PD-1 or PD-L1 inhibitor. Nevertheless, toxicity was also increased. Immunotherapy-related deaths due to encephalitis, renal failure and hepatitis were observed. Further studies are warranted.

In plain English

This editorial discussed partial results, presented at a meeting, from two clinical trials of combined checkpoint inhibitor immunotherapy for malignant mesothelioma. It did not report new data of its own. In the MAPS2 trial, patients with previously treated pleural mesothelioma were randomly assigned to nivolumab alone (63 patients) or nivolumab plus ipilimumab (62 patients). Tumors responded in 17.5% of the nivolumab-alone group (95% confidence interval 8.1 to 26.8) and 24.2% of the combination group (13.5 to 34.9), which the authors called numerically higher. Serious side effects (grade 3 or higher) occurred in 9.5% and 21.3% of these groups. The combination group had three treatment-related deaths, from fulminant hepatitis, metabolic encephalopathy and renal failure. The NIBIT-Meso1 trial had a single group: 40 patients with pleural or peritoneal mesothelioma received durvalumab plus tremelimumab. Its response rate was 25%, and 17.5% of patients had grade 3 or 4 side effects. The authors concluded that combined checkpoint inhibitors appear promising but are more toxic. They noted that full trial results were pending, samples were small, and more studies are needed.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Editorial commenting on partial results from two clinical trials presented at an international meeting (not an original study)
• Who was studied: MAPS2: previously treated patients with pleural mesothelioma, randomized to nivolumab alone (N 63) or nivolumab plus ipilimumab (N 62). NIBIT-Meso1: 40 patients with pleural or peritoneal mesothelioma, median age 64, treated first- or second-line. No locations or dates are given for the trials.
• Exposure: No asbestos exposure was studied. The treatments discussed were MAPS2: nivolumab 3 mg/kg every 2 weeks with or without ipilimumab (anti-CTLA-4) 1 mg/kg every 6 weeks. NIBIT-Meso1: durvalumab (anti-PD-L1) plus tremelimumab.
• Main results:
  • MAPS2: the authors described the tumor response rate as numerically higher with the combined immunotherapy
  • MAPS2: response rate was 17.5% (95% CI 8.1 to 26.8) with nivolumab alone and 24.2% (95% CI 13.5 to 34.9) with nivolumab plus ipilimumab
  • MAPS2: grade 3 or higher toxicities occurred in 9.5% of the nivolumab-alone arm and 21.3% of the combined arm
  • MAPS2: diarrhea occurred in 19.7% of the combined arm versus 6.3% of the nivolumab-alone arm. Pruritus (itching) occurred in 11.5% versus 1.6%.
  • MAPS2: three treatment-related deaths occurred in the combined arm, from fulminant hepatitis, metabolic encephalopathy and renal failure. There were none in the nivolumab-alone arm.
  • NIBIT-Meso1 (40 patients, durvalumab plus tremelimumab): overall response rate was 25%, and grade 3 or 4 toxicity occurred in 17.5% of patients
• The authors' conclusion: The authors concluded that combined checkpoint inhibitors appear promising for mesothelioma, that toxicity is clearly increased, and that additional studies are needed
• Limitations the authors state:
  • The full published results of both trials were still pending
  • Because of small sample size, more studies are needed to know whether the treatment-related deaths are a valid concern
  • NIBIT-Meso1 had no single-agent durvalumab comparison group

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Malignant Mesothelioma, Clinical Trial, Immunotherapy, checkpoint inhibitors, PD-L1, Mesothelioma, CTLA-4.

Related studies

• Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial — A. Scherpereel, J. Mazieres, et al. (2019)
• Ipilimumab/Nivolumab-related Opsoclonus-Myoclonus-Ataxia Syndrome Variant in a Patient with Malignant Pleural Mesothelioma — B. Maller, E. Peguero, et al. (2018)
• CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial — D.A. Fennell, E. Kirkpatrick, et al. (2018)
• Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine — S. Thunold, E. Hernes, et al. (2025)
• Programmed Death 1 Blockade With Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma — J. Quispel-Janssen, V. van der Noort, et al. (2018)
• Nivolumab for malignant peritoneal mesothelioma — T. Tanaka, Y. Miyamoto, et al. (2020)

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