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113 active trials for Metastatic Cancer

QUILT 3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers

Phase 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.

Start: July 2019

Pembrolizumab in Biliary Tract Cancer

This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab. Secondary objectives are: Assess the treatment efficacy in terms of overall survival, immune related progression-free survival, response rate (according to RECIST version 1.1), safety, symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21) Exploratory objectives include assessment of immunological response (cytokines, lymphocyte phenotype, immunoglobulins), and evaluation of pathological and clinical predictive factors for response/toxicity Translational research will focus on biomarkers for prediction of response and toxicity.

Start: January 2020

First in Human Study With NG-641, an Oncolytic Transgene Expressing Adenoviral Vector

To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.

Start: January 2020

A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors

This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.

Start: February 2021

Circulating Tumor DNA as Marker for Response to Antineoplastic Treatment of Metastatic Cancer (FLUIDO)

Early monitoring of antineoplastic treatment benefit is a central medical need. Radiologic assessment for documentation of response is done after several months of treatment usually. This implies that patients not responding are exposed to unnecessary toxicity. According to several reports showing the correlation of the amount of circulating tumour DNA with tumour burden we aim to investigate its early dynamic change at the beginning and during antineoplastic treament until radiologic response assessment. Blood samples necessary for that are taken within the scope of clinical routine care. We hypothesize that the changes of circulating tumour DNA correlate with the radiological findings.

Start: April 2021

FS120 First in Human Study in Patients With Advanced Malignancies

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS120. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS120 in participants with advanced tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Start: November 2020

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C mutation.

Start: January 2019

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

Start: October 2018

Exercise Therapy in Radiation Therapy

The purpose of this study is to evaluate exercise therapy as a method for potentially improving radiation therapy treatment toxicities for metastatic cancer patients receiving radiation therapy.

Start: February 2020

Predicting Disease Progression and/or Recurrence in Cancer

This is a prospective study addressing the challenge of predicting disease progression and/or recurrence in patients diagnosed with metastatic colorectal, pancreatobiliary, or esophagogastric cancer that are receiving anti-cancer therapy.

Start: April 2019

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Start: May 2016

Multi-Modal Palliative Care Intervention

Adults diagnosed with metastatic cancer commonly experience depression and anxiety symptoms, which can interfere with advance care planning. This randomized clinical trial evaluates a novel, piloted, primary palliative care intervention that addresses advance care planning and psychosocial needs of patients with metastatic cancer. The intervention focuses on patients with elevated anxiety and depression (anx/dep) symptoms-those with highest psychosocial needs who may be at greatest risk for advance care planning non-completion. The intervention is founded on an evidence-based intervention approach known as Acceptance and Commitment Therapy (ACT) that reduces distress and promotes behavior change through theory-driven mechanisms. In the proposed randomized trial, M-ACT will be compared to a usual care control condition. The study will also assess the association between advance care planning and anx/dep symptoms, thereby informing the critical practice question of whether anx/dep symptoms should be addressed concurrently with advance care planning. The study will enroll patients with Stage IV solid tumor cancer (N=240) within Rocky Mountain Cancer Centers, randomized 1:1 to M-ACT or usual care. The study aims to: 1) Evaluate the hypothesis that M-ACT will increase advance care planning completion (primary outcome) and sense of life meaning, and reduce anx/dep symptoms and fear of dying relative to usual care control. 2) Assess the association between anx/dep symptoms and advance care planning at baseline and over time, testing the hypothesis that decreases in anx/dep symptoms at post- intervention will be associated with increases in advance care planning at follow-up. 3) Assess M-ACT's hypothesized mechanisms to specify how the intervention works (exploratory aim). Given their advance care planning and psychosocial needs, and poor access to palliative care, rigorously investigating M-ACT has the potential to benefit community patients with metastatic cancer and to advance palliative care science by addressing gaps in novel approaches, foundational knowledge, and the scalable delivery of palliative care. Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.

Start: January 2021

CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.

Identification of biomarkers (Circulating Tumor Cells (CTC), free DNA, Stem Cells and EMT-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment in castration-resistant prostate cancer.

Start: December 2014

Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

This is a prospective, single arm, phase Ib/IIa study. Up to 25 patients will be enrolled into the study (Part A: 2-18; Part B: 7-19). The study has been designed to allow an investigation of the optimal combination dose and schedule whilst of Osimertinib plus Anlotinib in patients with EGFRm+, treatment-naïve IIIb/IV Non-Small Cell Lung Cancer (NSCLC) ensuring the safety of patients with intensive safety monitoring. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion.

Start: November 2020

Electronic Patient Reporting of Symptoms During Cancer Treatment

The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Start: October 2017

Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors

This first-in-human open-label, dose escalation study is designed to evaluate the safety, tolerability, and PK of MRX-2843 in subjects with relapsed/refractory advanced and/or metastatic solid tumors.

Start: May 2018

Biomarkers of Immune-Related Toxicity

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.

Start: February 2018

Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer

This is an open-label, single-center, single-arm phase II clinical trial evaluating the combination of pembrolizumab, binimetinib, and bevacizumab in patients with metastatic colorectal adenocarcinoma who have not responded to prior therapy.

Start: September 2018

Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors

In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. However, surgical treatment is possible only in 10-25% of patients. At the same time, recurrence of malignant tumors is observed in 60-80% of cases within five years after surgery, and the number of candidates for repeated liver resection does not exceed 10%. The high toxicity of systemic chemotherapy limits its use in this group of patients. In this connection, minimally invasive and at the same time effective methods of local treatment of malignant liver tumors have been introduced into clinical practice. These methods include: hepatic artery chemoinfusion, chemoembolization and oil chemoembolization. Currently, a large world experience has already been accumulated in the application of the above methods of treatment. However, any, even minimally invasive, surgical manipulation can be associated with the development of complications of varying severity. If complications arise, there is a risk of interruption of palliative care, which entails a significant reduction in life expectancy. According to domestic and foreign literature, the occurrence of complications after intra-arterial chemoembolization occurs in 0.4-10% of patients, and after intra-arterial chemoinfusion - in 5-30% of patients. In the overwhelming majority of scientific works, the description of the complications that have arisen is reduced to listing the latter. Currently, in the Russian and foreign scientific literature there is no systematization of complications, there is no single clinical classification, algorithms for the prevention and treatment of complications arising after local intravascular methods of treatment of patients with malignant liver tumors. The study and systematization of complications arising after intra-arterial chemoembolization and chemoinfusion of the hepatic artery in patients with malignant liver tumors will make it possible to create prevention and treatment algorithms. Thus, it will help prevent interruption of palliative care and increase the life expectancy of this cohort of patients.

Start: January 2021

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor

This is a Phase 1, open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study with cohort expansion at the RP2D to evaluate safety and anti- tumor activity of Q702 administered orally.

Start: November 2020