Clinical trial · Interventional
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
NCT04162015CI-TRIAL-00094987active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin or Carboplatin | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nivolumab with pemetrexed and cisplatin or carboplatin
- description
- Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication.
- interventionNames
- Drug: Nivolumab
- Drug: Pemetrexed
- Drug: Cisplatin or Carboplatin
Primary outcomes (1)
- measure
- number of patients going to operating room for surgical resection
- timeFrame
- 30 days of the initially planned date
- description
- Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Karnofsky performance status \> 70% * Pathologic diagnosis of malignant pleural mesothelioma. * Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon * Negative serum pregnancy test in women of childbearing potential * Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer * Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer * Adequate archival or fresh tissue for correlative analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible * Absolute neutrophil count ≥ 1000/mcL * Total bilirubin ≤ 1.5 mg/dl * AST and ALT ≤ 3.0 x upper limit of normal * Creatinine ≤ 1.5 x upper limit of normal * Negative HIV serology blood test Exclusion Criteria: * Prior treatment with chemotherapy or immunotherapy for mesothelioma * Autoimmune disease requiring systemic immune modulating treatment during the past two years * Pregnant or lactating women * Known active hepatitis B or hepatitis C * Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid) * Serious concurrent medical illness or another active cancer requiring treatment * Active pneumonitis
References
Publications (0)
Data not yet available
No reference posted for this study.