Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/16/2024. Questions regarding updates should be directed to the study team contact.