Testing the Addition of Immunotherapy Before Surgery for Patients with Sarcomatoid Mesothelioma

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Dec 9, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well immunotherapy, specifically a combination of two medications called nivolumab and ipilimumab, works when given before surgery for patients with a specific type of lung cancer known as sarcomatoid mesothelioma. The goal is to see if this treatment can help control the disease better than just having surgery alone. The trial is currently recruiting patients aged 18 and older who have been diagnosed with stage I to IIIa sarcomatoid mesothelioma and have not received other treatments that would affect the trial's results.

Eligible participants can expect to receive immunotherapy for a certain period before undergoing surgery. It's important for potential participants to know that they should not have other conditions that could complicate their treatment or surgery. For example, patients with certain heart issues or those who cannot have surgery will not be included in the study. Overall, this trial aims to find out if giving immunotherapy before surgery can improve outcomes for patients battling this challenging form of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sarcomatoid or sarcomatoid-dominant (\> 50%) biphasic, pleural mesothelioma
• • Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition
• • Measurable disease or non-measurable disease as defined
• • No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint
• • No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.)
• • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
• • \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
• • Age \>= 18 years
• • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 or Karnofsky \>= 60%
• • Absolute neutrophil count (ANC) \>= 1,000/mm\^3
• • Leukocytes \>= 2,000/mm\^3
• • Platelet count \>= 100,000/mm\^3
• • Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \>= 40 mL/min
• • Total bilirubin =\<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dl
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN
• • Alkaline (alk) phosphatase (phos) =\< 3.0 x ULN
• • No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
• • No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody
• • No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study
• • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
• • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• • STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery
• • STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection
• • STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =\< 2 or Karnofsky \>= 60%
• • STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) \> 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) \> 35%
• • STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy
• Exclusion Criteria:
• • No patients deemed to be unresectable or poor surgical candidates
• • No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes
• • No patients with a history of symptomatic interstitial lung disease