Neuroendocrine Tumors Clinical Trial
Official title:
A Phase II, Multi-Cohort Trial of Combination Nivolumab and Temozolomide in Recurrent/Refractory Small-Cell Lung Cancer and Advanced Neuroendocrine Tumors
This phase II trial studies how well nivolumab and temozolomide work in treating patients with small-cell lung cancer that has come back or does not respond to treatment, or neuroendocrine cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and temozolomide may work better in treating patients with small-cell lung cancer and neuroendocrine cancer.
PRIMARY OBJECTIVES: I. To evaluate the efficacy (using response rate per RECIST v1.1) of nivolumab and temozolomide for the treatment of patients with either small cell lung cancer that have progressed or recurred after prior platinum-based chemotherapy and immunotherapy (cohort 1), or progressive metastatic neuroendocrine carcinoma of any grade or primary site in any line of therapy (cohort 2). SECONDARY OBJECTIVES: I. To evaluate the safety profile and toxicity of combination nivolumab and temozolomide as per Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0. II. To evaluate the progression free survival (PFS) and overall survival (OS) of patients treated with combination nivolumab and temozolomide. III. To evaluate the central nervous system (CNS) PFS of patients with small cell lung cancer (SCLC) treated with nivolumab and temozolomide. EXPLORATORY OBJECTIVES: I. To determine whether treatment with nivolumab and temozolomide leads to a decrease in immune-suppressive cell populations (ie myeloid-derived suppressor cells [MDSC]) in peripheral blood. II. To determine whether objective response rate (ORR), PFS, OS vary by tumor O6-methylguanine deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation at baseline. III. To determine whether baseline tumor mutational burden is predictive of response to therapy in patients with SCLC treated with nivolumab and temozolomide. IV. To determine whether changes in blood based mutation burden during treatment may predict clinical benefit. V. To determine whether a composite immune and tumor cell staining score can be developed with or without PD-L1 by immunohistochemistry (IHC) to predict response in the SCLC cohort. OUTLINE: Patients receive nivolumab intravenously (IV) on day 1 of a 28 day cycle. Patients also receive temozolomide orally (PO) on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 8 weeks for 12 months, then every 12 weeks thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01218555 -
Study of Everolimus (RAD001) in Combination With Lenalidomide
|
Phase 1 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Withdrawn |
NCT04614766 -
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05556473 -
F-Tryptophan PET/CT in Human Cancers
|
Phase 1 | |
| Completed |
NCT03273712 -
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|
Phase 2 | |
| Recruiting |
NCT05636618 -
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
| Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
| Completed |
NCT02815969 -
The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
|
||
| Completed |
NCT02441062 -
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02174549 -
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02132468 -
A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers
|
Phase 2 | |
| Completed |
NCT02134639 -
PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation
|
N/A | |
| Recruiting |
NCT01201096 -
Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)
|
N/A | |
| Terminated |
NCT01163526 -
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies
|
N/A | |
| Completed |
NCT01099228 -
Combination Targeted Radiotherapy in Neuroendocrine Tumors
|
N/A | |
| Completed |
NCT00171873 -
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
|
Phase 3 | |
| Active, not recruiting |
NCT05077384 -
Open-label Study of Surufatinib in Japanese Patients
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04544098 -
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
|
Early Phase 1 | |
| Active, not recruiting |
NCT02736500 -
Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors
|
Phase 1/Phase 2 |