Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies...
Metastatic NeoplasmPrimary Objectives: Part 1 To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. Part 2 To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. Part 3A To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC Part 3B To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC Part 4 To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: Part 1 To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. To estimate the anti-tumor effects of SAR442720 with pembrolizumab. Part 2 To assess the safety profile of SAR442720 combined with pembrolizumab. To assess other indicators of anti-tumor activity. To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. Part 3A To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. To estimate the anti-tumor effects of SAR442720 with adagrasib Part 3B To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. To assess other indicators of anti-tumor activity. To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. Part 4 To assess the safety and tolerability of SAR442720 formulations with pembrolizumab To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With...
Squamous Cell Carcinoma of Head and NeckCarcinoma5 moreThis is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.
Combined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung...
Lung CancerMetastatic CancerThe purpose of this study is to evaluate a new radiation planning and treatment delivery technique called Deep Inspiration Breath Hold (DIBH) and expiration technique. This technique will be used to treat patients who have tumors close to the chest wall and are candidates for Stereotactic Body Radiation Therapy (SBRT). This study will assess the reduction of radiation to the chest wall during treatment using this technique.
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET)...
Metastatic TumorsStereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.
Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without...
Hepatic MetastasesColon Cancer1 moreThe purpose of this study is to determine whether the addition of bevacizumab, to hepatic arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will increase disease free survival in patients who have undergone liver resection. The patient will be randomized (a computer generated decision as in the flip of a coin) to receive, or not to receive bevacizumab in addition to regional and systemic chemotherapy.
Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma...
Uveal MelanomaLiver MetastasesUveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumour, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. Isolated hepatic perfusion is a regional treatment where the liver is completely isolated from the systemic circulation, allowing a high concentration of chemotherapy to be perfused through the liver with minimal systemic exposure. The introduction of modern immunotherapy in the treatment arsenal for cutaneous melanoma also creates hope for patients with uveal melanoma metastases. However, the results of immunotherapy have so far been disappointing. The reason for the low efficacy could be that uveal melanoma develops in the immune privileged eye. The hypothesis in this trial is that isolated hepatic perfusion with melphalan causes an immunogenic type of cell death by local tumour destruction while leaving the immune-system intact. This will cause an activation of the immune-system and the addition of ipilimumab and nivolumab will enhance this effect, ultimately increasing the treatment efficacy. The primary objective of this trial is to evaluate the safety and tolerability of isolated hepatic perfusion together with ipilimumab and nivolumab when given at the same time or as a sequenced regimen. The study design is a phase I randomized controlled, multicentre, open-label trial. Active follow-up will be performed for 2 years. Patients will be randomized after diagnoses of metastatic disease to one of the following treatment arms: Arm A. Patients will be treated with IHP followed by 4 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year. Arm B. Patients will be treated with 1 course of ipilimumab 3mg/kg and nivolumab 1mg/kg followed by IHP after 3 weeks and then another 3 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year.
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase...
Secondary Progressive Multiple SclerosisPrimary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers
Locally Advanced Solid TumorMetastatic Cancer1 morePhase 1 study to assess the safety, preliminary efficacy of PD-L1 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with locally advanced or metastatic solid cancers.
A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm
Lung TumorMetastatic CancerThis is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. These are subjects who have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.
Intrathecal Pemetrexed for Leptomeningeal Metastasis
Leptomeningeal MetastasesIntrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal metastasis of solid tumors. In the previous study(Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A Prospective Pilot Clinical Trial. ClinicalTrials.gov identification number: NCT03101579), pemetrexed presented feasibility of intrathecal administration. Pemetrexed at 10 mg dose level on the schedule of 1-2 times per week was recommended as an intrathecal administration agent for patients with refractory leptomeningeal metastases from non-small-cell lung cancer in the previous study. Moreover, the maximum-tolerated dose and recommended dose of intrathecal pemetrexed in the previous study was obtained without vitamin supplementation. Vitamin supplementation has been shown to reduce pemetrexed-induced myelosuppression. In this study, the regimen of intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide higher safety. Therefore, the purpose of this study is to investigate the maximally tolerated dose and evaluate the safety and effectiveness of intrathecal pemetrexed with vitamin supplementation as the first-line intrathecal chemotherapy in patients with leptomeningeal metastases from malignant solid tumors.