Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive P… (NCT03126630) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma
United States49 participantsStarted 2018-10-04
Plain-language summary
This phase I/II trial studies the side effects and how well pembrolizumab with or without anetumab ravtansine works in treating patients with mesothelin-positive pleural mesothelioma. Anetumab ravtansine is a monoclonal antibody, called anetumab, linked to a chemotherapy drug, called ravtansine. Anetumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as mesothelin receptors, and delivers ravtansine to kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and anetumab ravtansine may work better in treating patients with mesothelin-positive pleural mesothelioma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION
* Patients must have histologically or cytologically confirmed malignant pleural mesothelioma
* Patient is willing to submit a tissue sample to test for expression of mesothelin
* Note: Tissue sample for mesothelin assay may have been collected prior to, during or after receipt of the frontline chemotherapy; patients will not be required to submit another tissue sample after receipt of the chemotherapy
* Patients must have received platinum based chemotherapy
* REGISTRATION
* For phase 2 only:
* Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for non-pleural disease or modified RECIST 1.1 (mRECIST) for pleural disease
* Note: For pleural disease, this is defined as at least one lesion that can be accurately measured perpendicular to the chest wall or mediastinum that is \>= 10 mm (\>= 1 cm); for extra pleural disease, measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm (\>= 1 cm) for non-nodal lesions and \>= 15 mm (\>= 1.5 cm) for nodal lesions with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam as per RECIST 1.1
* Tissue submitted for testing at pre-registration shows moderate or stronger mesothelin expression in \>= 30% of the tumor cells
* For phase 1 and 2:
* Patients mu…
What they're measuring
1
Phase 2 Confirmed Tumor Response Rate (Phase II)
Timeframe: Up to 2 years
2
Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab