Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Hypoglycemic Agents

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Amino Acids

Gemcitabine

Docetaxel

Bevacizumab

Atezolizumab

Carboplatin

Pemetrexed

Sacituzumab govitecan

Immunomodulating Agents

Ipatasertib

Evolocumab

Linagliptin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immune Checkpoint Inhibitors

Incretins

Hormones

Hormone Antagonists

Dipeptidyl-Peptidase IV Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

PCSK9 Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Serine Proteinase Inhibitors

Immunoconjugates

Immunologic Factors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Serine

Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression.

Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.

Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.

Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.

Cobimetinib

Cycle 1:

RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage.

Subsequent cycles:

RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.

RO6958688

Docetaxel is administered by IV on Day 1 of each 21 day cycle.

CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.

CPI-444

Pemetrexed is administered by IV on Day 1 of a 21 day cycle.

Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.

Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.

Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.

Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.

Tocilizumab

Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.

Bevacizumab is administered by IV on Day 1 of each 21-day cycle.

Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.

Sacituzumab Govitecan

Radiation

Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.

Tiragolumab is administered on Day 1 of each 21 day cycle.

Tiragolumab

XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.

XL092

Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.

Camonsertib

Clinical Trials

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Hoffmann-La Roche

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Nivolumab

If you are found to be eligible to take part in this study, you will receive evolocumab and nivolumab on Day 1 of each cycle (every 4 weeks). Evolocumab will be given as an injection under the skin. Nivolumab will be given by vein over about 60 minutes.

Eric Jonasch, MD

To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied.

Primary Objectives:

- To determine the objective response rate (Partial Response (PR) and Complete Response (CR)) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria and immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria of evolocumab and nivolumab in patients with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade

To confirm safety of evolocumab and nivolumab in participants with metastatic renal cell carcinoma (mRCC) refractory to immunotherapy and/or Vascular endothelial growth factor (VEGF) blockade Detail the primary protocol objectives.

Secondary Objectives:

* To describe the adverse events associated with evolocumab and administered with nivolumab
* To determine the disease control rate (Stable Disease (SD)/PR/CR) based on RECIST 1.1 and iRECIST criteria
* To determine duration of response in patients who achieve response
* To determine progression free survival based on RECIST 1.1 criteria and iRECIST criteria
* To determine 1-year survival rates and overall survival

Exploratory Objectives:

* To evaluate CD3 and CD8 T-cell infiltration and MHC-1 expression of paired tumor biopsies before and after treatment
* To evaluate plasma low-density lipoproteins (LDL) cholesterol levels and circulating Proprotein convertase subtilisin/kexin type 9 (PSCK9) levels at baseline and on treatment
* To evaluate circulating lymphoid and myeloid cell subsets and changes on treatment
* To evaluate circulating tumor cells and changes on treatment

A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Bristol-Myers Squibb

Cancer Prevention Research Institute of Texas

United States Department of Defense

M.D. Anderson Cancer Center

Ipilimumab

Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.

Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks

Anne M Peters, RN

Christy Arrowood, RN

Ann M Peters, RN

Scott Antonia, MD

This is a research study to find out the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer (a type called non-small cell lung cancer).

Nivolumab (Opdivo™) and ipilimumab (Yervoy™) are immunotherapy-type drugs which are approved for the treatment of advanced lung cancer that has expression of PD-L1 greater than or equal to 1%. Evolucumab is being combined with nivolumab and ipilimumab to see if it will improve the anti-tumor capabilities of the immunotherapy. Adding evolocumab to the combination of nivolumab and ipilimumab has not been tested in people before and is considered investigational.

A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC

A Randomized Pilot Study to Investigate the Safety and Immunologic Impact of Evolocumab When Given in Combination With Ipilimumab and Nivolumab in Treatment-Naïve Patients With Metastatic Non-Small Cell Lung Cancer

Safety is defined as the incidence of DLTs assessed in the first 6 evaluable subjects

To characterize treatment-related changes in tumor infiltrating lymphocytes (TIL) using immunohistochemistry analysis. The mean and the standard deviation of the pre-treatment CD3+ TILs and the on-treatment CD3+ TILS as well as those of the difference of these ratios will be estimated.

To assess the change in the degree of surface expression of MHC-I molecules on tumor cells within each patient comparing on-treatment versus pre-treatment biopsy specimens

PFS is defined as the time between initiation of treatment and initial failure (disease progression or death), whichever comes first.

OS is defined as the time from the first dose of study treatment to death.

Response rate is defined as the proportion of treated subjects with a complete or partial response

Scott Antonia

Professor of Medicine

Symptoms and General Pathology

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

420 mg of evolocumab subcutaneous injection 7-14 days before scheduled surgery for malignant glioma

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Erin Severance, BA

This Phase 0 surgical window of opportunity trial seeks to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an FDA-approved proprotein convertase/ kexin type 9 serine protease inhibitor (PCSK9i) in patients with primary and recurrent World Health Organization (WHO) grade IV malignant glioma. The investigators intend to evaluate whether a clinically licensed PCSK9i called evolocumab (also known as Repatha) can be repurposed as a potential immunotherapeutic for high grade glioma by testing its ability to access the intracranial space. The primary objective is to evaluate whether evolocumab crosses the blood brain barrier (BBB) and is measurable in the resected tumor specimens of patients with primary and recurrent high grade glioma or glioblastoma.

A maximum of 10 participants will receive 420 mg (the maximum single dose) of evolocumab subcutaneously into their thigh, abdomen or upper arm 7-14 days prior to surgical de-bulking of their tumor. After de-bulking, leftover tissue not required for histological analysis will be collected, and the level of evolocumab will be quantified. At two time points, prior to injection of evolocumab and at time of their surgery, participants will have peripheral blood drawn to analyze serum levels of the drug (for comparison to levels found in their leftover tissue). The investigators will follow-up with participants about 2 weeks after surgery at their post-operative visit.

A matched cohort of resected tumor specimens from patients who were not treated with evolocumab from the Duke Brain Tumor Center Biorepository will be used as a comparison for the primary objective and 2 of the 3 secondary objectives of this study comparing brain tumor tissue specimens of patients who did and did not receive evolocumab with respect to lipid metabolism and tumor cells expressing MHC-I.

The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation

PEskE: A Phase 0/Surgical Window-of-opportunity Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Evolocumab in Patients With Recurrent High-grade Glioma or Glioblastoma

Determined by fluorescence-activated cell sorting (FACS)

Using serum taken before receiving evolocumab (7-14 days before surgery) and serum taken at the time of surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)	NCT03337698	Carcinoma, Non-...	Atezolizumab Cobimetinib RO6958688 Docetaxel CPI-444 Pemetrexed Carboplatin Gemcitabine Linagliptin Tocilizumab Ipatasertib Bevacizumab Sacituzumab Gov... Radiation Evolocumab Tiragolumab XL092 Camonsertib	18 Years -	Hoffmann-La Roche
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)	NCT06284564	Metastatic Rena...	Evolocumab Nivolumab	18 Years -	M.D. Anderson Cancer Center
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC	NCT05144529	Lung Cancer Met...	Nivolumab Ipilimumab Evolocumab	18 Years -	Duke University
The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation	NCT04937413	Malignant Gliom... Glioblastoma	Evolocumab	18 Years -	Duke University
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)	NCT06284564	Metastatic Rena...	Evolocumab Nivolumab	18 Years -	M.D. Anderson Cancer Center
A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC	NCT05144529	Lung Cancer Met...	Nivolumab Ipilimumab Evolocumab	18 Years -	Duke University

Spots Global Cancer Trial Database for evolocumab

Every month we try and update this database with for evolocumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for evolocumab

Every month we try and update this database with for evolocumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for evolocumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.