Pleural Biphasic Mesothelioma Clinical Trial
Official title:
Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma
This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | PCR Oncology | Arroyo Grande | California |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | Overlake Medical Center | Bellevue | Washington |
United States | Carson Tahoe Regional Medical Center | Carson City | Nevada |
United States | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Carle at The Riverfront | Danville | Illinois |
United States | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Christiana Care - Union Hospital | Elkton | Maryland |
United States | Beebe South Coastal Health Campus | Frankford | Delaware |
United States | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | Northwestern Medicine Glenview Outpatient Center | Glenview | Illinois |
United States | Northwestern Medicine Grayslake Outpatient Center | Grayslake | Illinois |
United States | Cancer and Blood Specialists-Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada |
United States | GenesisCare USA - Henderson | Henderson | Nevada |
United States | Las Vegas Cancer Center-Henderson | Henderson | Nevada |
United States | Las Vegas Urology - Green Valley | Henderson | Nevada |
United States | Las Vegas Urology - Pebble | Henderson | Nevada |
United States | OptumCare Cancer Care at Seven Hills | Henderson | Nevada |
United States | Urology Specialists of Nevada - Green Valley | Henderson | Nevada |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Kingman Regional Medical Center | Kingman | Arizona |
United States | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada |
United States | Ann M Wierman MD LTD | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada |
United States | GenesisCare USA - Fort Apache | Las Vegas | Nevada |
United States | GenesisCare USA - Las Vegas | Las Vegas | Nevada |
United States | GenesisCare USA - Vegas Tenaya | Las Vegas | Nevada |
United States | Hope Cancer Care of Nevada | Las Vegas | Nevada |
United States | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada |
United States | Las Vegas Prostate Cancer Center | Las Vegas | Nevada |
United States | Las Vegas Urology - Cathedral Rock | Las Vegas | Nevada |
United States | Las Vegas Urology - Pecos | Las Vegas | Nevada |
United States | Las Vegas Urology - Smoke Ranch | Las Vegas | Nevada |
United States | Las Vegas Urology - Sunset | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Charleston | Las Vegas | Nevada |
United States | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada |
United States | OptumCare Cancer Care at MountainView | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | University Cancer Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Urology Specialists of Nevada - Central | Las Vegas | Nevada |
United States | Urology Specialists of Nevada - Northwest | Las Vegas | Nevada |
United States | Urology Specialists of Nevada - Southwest | Las Vegas | Nevada |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Medical Oncology Hematology Consultants PA | Newark | Delaware |
United States | Northwestern Medicine Orland Park | Orland Park | Illinois |
United States | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada |
United States | Mayo Clinic Hospital in Arizona | Phoenix | Arizona |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Radiation Oncology Associates | Reno | Nevada |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Saint Mary's Regional Medical Center | Reno | Nevada |
United States | Valley Medical Center | Renton | Washington |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware |
United States | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Rush-Copley Healthcare Center | Yorkville | Illinois |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biomarkers | The association of pre-treatment and on-treatment biomarkers in peripheral blood and in tumor tissues with response and time to recurrence, will be evaluated univariately through Chi-square test or log-rank test and through logistic regression model or Cox regression model with other prognostic factors adjusted. | Up to 5 years | |
Primary | Surgery Rate | The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated. | immediately after the completion of neoadjuvant immunotherapy and surgery | |
Primary | Progression free survival (PFS) | PFS will be determined per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The rate of PFS at 12 months after the initiation of neoadjuvant immunotherapy among the feasibility and efficacy analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated. | At 12 months after initiation of neoadjuvant immunotherapy | |
Secondary | Incidence of adverse events | The type of adverse events, the frequency of each type and its grade will be summarized. The frequency and the percentage of severe adverse events will be presented in bar charts over treatment phase (neoadjuvant immunotherapy, surgery) to describe the change of adverse event or complication severity over time. The rates of the pre-operative or post-operative complications (within 30 days of surgery) will be estimated with its exact 95% confidence interval. | Up to 5 years | |
Secondary | Objective response rate | Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval. | Up to 5 years | |
Secondary | Major pathologic response | Defined as =< 10% residual viable tumor in the resected lung and lymph node tissue. Response rates will be reported with 95% exact confidence interval. | Up to 5 years | |
Secondary | Time to recurrence | Time to recurrence will be estimated among those patients who receive surgery and will be characterized by estimating cumulative incidence function and conducting cause-specific and subdistribution hazard regression. | Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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