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New treatment option for Pleural Biphasic Mesothelioma
Official title Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
ClinicalTrials.gov ID: NCT05647265
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pleural biphasic mesothelioma.
Also referred to as 946414-94-4, BMS-936558, CMAB819, MDX-1106, NIVO, NIVOLUMAB, Nivolumab, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- No patients with a history of symptomatic interstitial lung disease
See the full eligibility 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...
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- Leukocytes \>= 2,000/mm\^3
- Platelet count \>= 100,000/mm\^3
- Creatinine =\ = 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...
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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 =\ = 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
- 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...
- No patients with a history of symptomatic interstitial lung disease
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- La Jolla, California, United States
- Napa, California, United States
- Santa Rosa, California, United States
- Lewes, Delaware, United States
- Millville, Delaware, United States
- Newark, Delaware, United States
- Rehoboth Beach, Delaware, United States
- Wilmington, Delaware, United States
- Jacksonville, Florida, United States
- Boise, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Twin Falls, Idaho, United States
+ 57 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Arroyo Grande, California, United States; Burbank, California, United States and 71 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.