First-Line Nivolumab Plus Ipilimumab in Inoperable Epithelioid Malignant Pleural Mesothelioma: Real-World Experience From an Indian Tertiary Care Center

Our plain-English summary of First-Line Nivolumab Plus Ipilimumab in Inoperable Epithelioid Malignant Pleural Mesothelioma: Real-World Experience From an Indian Tertiary Care Center, by A. Shah, A. Agarwal, V. Rajpuria, et al (Curēus, 2026).

The study

• Authors: A. Shah, A. Agarwal, V. Rajpuria, S. Ghodasara, J. Swami, V. Kanth, H. Dangar, A. Jakhetiya
• Journal: Curēus
• Published: 2026;18(7):e113313
• Read it: PubMed · Publisher · Free full text

Abstract

Background Malignant pleural mesothelioma (MPM) is a highly aggressive, rare malignancy with poor prognosis. Standard frontline treatments have traditionally relied on platinum-based chemotherapy doublets, which offer limited long-term survival benefit. This study evaluates the efficacy, clinical-demographic profile, and safety of first-line dual checkpoint inhibition using nivolumab and ipilimumab in patients with inoperable MPM within an Indian tertiary care setting. Materials and methods A retrospective study was conducted from January 2021 to August 2023 at a single tertiary care center in India. Fifteen patients aged ≥ 18 years with histologically confirmed, previously untreated, metastatic/inoperable epithelioid MPM and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 were included. Patients received nivolumab (240 mg intravenously every two weeks) combined with ipilimumab (1 mg/kg intravenously every six weeks) until disease progression or unacceptable toxicity. Response assessments were performed using positron emission tomography (PET) scans at three months using modified RECIST criteria. The primary objective of this study was to evaluate the real-world overall survival (OS), including median OS and one-year OS and safety profile. Secondary objectives included the assessment of objective response rate (ORR) at first reassessment using modified RECIST criteria and the characterization of the clinical-demographic landscape of this population and toxicity profile. Results The cohort consisted of 15 patients (median age: 65 years, range: 40-76), comprising eight males (54%) and seven females (46%). The median number of administered treatment cycles was seven for nivolumab (range: 2-26) and three for ipilimumab (range: 1-10). At the three-month evaluation, nine patients (60%) achieved a partial response, maintaining a stable response through the 12-month follow-up. Six patients (40%) experienced disease progression after the initial assessment, experiencing an OS of less than nine months. At the 12-month endpoint, the one-year OS rate was 60%, with nine patients alive and continuing immunotherapy. Treatment-related adverse events (TRAEs) occurred in 12 patients (80%), with Grade 3 or 4 TRAEs reported in four patients (26%). The most common all-grade TRAEs were diarrhea (26%), hypothyroidism/thyroiditis (20%), and rash (13%). Grade 3/4 toxicities included hepatitis (6%) and severe diarrhea (13%). Conclusion First-line treatment with combined nivolumab and ipilimumab demonstrates promising clinical efficacy, durable responses, and a manageable safety profile in Indian patients presenting with inoperable epithelioid MPM. These real-world outcomes align closely with global clinical trial benchmarks, supporting a chemotherapy-free dual-immunotherapy strategy. Larger prospective randomized trials are needed to validate these findings within the regional population.

Copyright © 2026, Shah et al.

In plain English

This was a retrospective review of medical records at one tertiary medical college hospital in Udaipur, Rajasthan, India, covering January 2021 to August 2023. It included 15 adults with previously untreated, inoperable or metastatic epithelioid malignant pleural mesothelioma. Their first treatment was nivolumab every two weeks plus ipilimumab every six weeks. No patient had a history of asbestos exposure. At the three-month PET-CT scan, nine patients (60%) had a partial response and six (40%) had progressed. None had a complete response or stable disease. The nine responders kept tumor control through 12 months. All six who progressed survived less than nine months despite later chemotherapy. Estimated survival was 60% at 12 months, and median overall survival was not reached. Twelve patients (80%) had treatment-related side effects, and four (26.7%) had severe (Grade 3 or 4) ones, including diarrhea and hepatitis. There were no treatment-related deaths. The authors concluded that the regimen was a safe, viable option for these patients and called for larger trials. They noted the study's retrospective, single-center design, lack of a comparison group and small size.

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: Single-center retrospective study of medical records
• Who was studied: 15 adults aged 18 or older with previously untreated, advanced, metastatic or inoperable epithelioid malignant pleural mesothelioma and ECOG performance status 0 to 2, treated at a tertiary medical college hospital in Udaipur, Rajasthan, India, January 2021 to August 2023. Sarcomatoid and biphasic subtypes were excluded. Median age was 65 years (range 40 to 76); there were 8 males (53.3%) and 7 females (46.7%).
• Exposure: Not an asbestos exposure study. The exposure was first-line treatment with nivolumab 240 mg intravenously every two weeks plus ipilimumab 1 mg/kg intravenously every six weeks, given until disease progression or unmanageable toxicity. No patient had a history of asbestos exposure.
• Main results:
  • None of the 15 patients had a history of asbestos exposure.
  • At the three-month PET-CT assessment, 9 of 15 patients (60%) had a partial response. This group kept tumor control through the 12-month observation period.
  • 6 patients (40%) had disease progression at or before the three-month scan. None achieved complete response or stable disease, giving an objective response rate of 60%.
  • All six patients whose disease progressed survived less than nine months, despite later salvage chemotherapy.
  • Median overall survival was not reached within the 12-month study period. Estimated survival in the whole cohort was 87% at three months, 80% at six months and 60% at 12 months.
  • Treatment-related side effects of any grade occurred in 12 patients (80%), and Grade 3 or 4 side effects in 4 patients (26.7%).
  • Diarrhea occurred in 4 patients (26.7%); in 2 of them (13.3%) it reached Grade 3/4 and needed corticosteroids. 3 patients (20%) developed low-grade hypothyroidism or thyroiditis. 2 patients (13.3%) had low-grade rash. 1 patient (6.7%) had Grade 3/4 immune-mediated hepatitis.
  • There were no treatment-related deaths. Treatment was stopped only because of disease progression, never because of side effects.
• The authors' conclusion: The authors concluded that first-line nivolumab plus ipilimumab was a safe, viable, chemotherapy-sparing option for metastatic or inoperable epithelioid malignant pleural mesothelioma. They said its outcomes aligned with published global benchmark data, and they called for large multi-center prospective randomized trials in the Indian subcontinent.
• Limitations the authors state:
  • Retrospective design, no comparison group, possible selection bias, limited follow-up, a single center, and a modest sample size.

Topics

Medical terms in this study, explained in our Lexicon: Nivolumab (Opdivo), Ipilimumab (Yervoy), Epithelioid, Pleural Mesothelioma, Prognosis, Chemotherapy, Performance Status, Disease Progression.

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