CLINICAL TRIAL

TAK-500 for Squamous Cell Cancer

Recruiting · 18+ · All Sexes · Boston, MA

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

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About the trial for Squamous Cell Cancer

Eligible Conditions
Neoplasms, Squamous Cell · Malignant Neoplasm of Pancreas · Liver Neoplasms · Squamous Cell Cancer (SCC) · Breast Cancer · Esophageal Neoplasms Malignant · Non-small Cell Lung Cancer (NSCLC) · Malignant Neoplasm of Stomach · Carcinoma, Squamous Cell · Hepatocellular Cancer (HCC) · Triple Negative Breast Neoplasms · Carcinoma · Mesothelioma · Adenocarcinoma · Carcinoma, Hepatocellular

Treatment Groups

This trial involves 3 different treatments. TAK-500 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
TAK-500
DRUG
Experimental Group 2
TAK-500
DRUG
+
Pembrolizumab
DRUG
Experimental Group 3
TAK-500
DRUG
+
Pembrolizumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Individuals with the following pathologically-confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease have progressed on or are intolerant to all standard therapy: gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, and triple-negative breast cancer (TNBC). Intolerant participants are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
Must have at least 1 RECIST version 1.1 evaluable lesion.
Absolute neutrophil count (ANC) greater than or equal to (>=) 1000/microliter (mcL), platelet count >=75,000/mcL, and hemoglobin >= 8.0 grams per deciliter (g/dL) without growth factor support for ANC or transfusion support for platelets within 14 days before the first study treatment dose.
Total bilirubin <=1.5 times the institutional upper limit of normal (ULN). For participants with Gilbert's disease or HCC, <=3 milligrams per deciliter (mg/dL).
Serum alanine aminotransferase and aspartate aminotransferase <=3.0*ULN or <=5.0*ULN with liver metastases or HCC.
Albumin >=3.0 g/dL.
Calculated creatinine clearance using the Cockcroft-Gault formula >=30 mL/minute.
Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.
For participants with HCC only: Child-Pugh score less than or equal to 7 (Child-Pugh A or B7).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 30 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 30 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether TAK-500 will improve 5 primary outcomes and 17 secondary outcomes in patients with Squamous Cell Cancer. Measurement will happen over the course of Cycle 1 (Cycle length is equal to [=] 21 [dose escalation] or 42 days [dose expansion]).

Pharmacologically Active Dose (PAD) range of TAK-500 SA and in Combination With Pembrolizumab
CYCLE 1 (CYCLE LENGTH IS EQUAL TO [=] 21 [DOSE ESCALATION] OR 42 DAYS [DOSE EXPANSION])
PAD is defined as any dose at which there is pharmacodynamic evidence of TAK-500-mediated activation of the innate and adaptive immune system and/or clinical anti-tumor activity includes: confirmed partial response (cPR) or confirmed complete response (cCR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Complete response (CR): defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). Partial response (PR): defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Recommended Phase 2 Dose (RP2D) of TAK-500 SA and in Combination With Pembrolizumab
CYCLE 1 (CYCLE LENGTH = 21 [DOSE ESCALATION] OR 42 DAYS [DOSE EXPANSION]
Changes in Tumor Immune Cell Infiltration and Activation as Measured by Immunohistochemistry or In-Situ Hybridization
UP TO 23 DAYS AFTER FIRST ADMINISTRATION OF TAK-500
Measurement of changes in tumor immune cell infiltration and activation as measured by immunohistochemistry or in-situ hybridization on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
Changes in Tumor Immune Cell Activation as Measured by Gene Expression
UP TO 23 DAYS AFTER FIRST ADMINISTRATION OF TAK-500
Measurement of changes in interferon- and STING-related gene expression as measured from fresh tumor biopsies pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
CYCLE 1 DAY 1, AND CYCLE 2 DAY 1: PRE-INFUSION AND AT MULTIPLE TIME POINTS (UP TO 21 DAYS) POST-INFUSION (CYCLE LENGTH=21 DAYS)
CL: Total Clearance After Intravenous Administration for TAK-500
CYCLE 1 DAY 1, AND CYCLE 2 DAY 1: PRE-INFUSION AND AT MULTIPLE TIME POINTS (UP TO 21 DAYS) POST-INFUSION (CYCLE LENGTH=21 DAYS)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes malignant neoplasm of pancreas?

It is believed that environmental factors are more important in malignant neoplasm development than hereditary factors. Dietary factors, like chronic alcohol abuse, appear to be associated with malignant neoplasm of pancreas and other malignant neoplasm.

Anonymous Patient Answer

What is malignant neoplasm of pancreas?

Chronic pancreatitis patients with a benign tumour had a higher risk of pancreatic cancer than that of those with chronic pancreatitis without a benign tumour; it may be due in part to chronic pancreatitis.

Anonymous Patient Answer

Can malignant neoplasm of pancreas be cured?

Patients with metastatic pancreatic cancer can obtain remission by surgery without chemotherapy and by administering immunoimmunotherapy. Immunotherapy combined with chemotherapy can benefit as well as the immunotherapy without chemotherapy. The immunotherapy combined with chemotherapy is even better than immunotherapy alone.

Anonymous Patient Answer

What are common treatments for malignant neoplasm of pancreas?

Pancreatic cancer is a malignant tumor in which new therapies are appearing both by the ways of chemotherapy and by the means of biologic therapy. A combination of fluorouracil and DDP is active. Also with a combination of gemcitabine and nab-paclitaxel, a promising solution for the therapy of pancreatic cancer, could be found. In addition, the use of the monoclonal antibody rituximab achieves positive results in the adjuvant therapy.

Anonymous Patient Answer

What are the signs of malignant neoplasm of pancreas?

PSA and abdominal pain are the most striking signs. The presence of jaundice is not very common in malignant neoplasm of pancreas. As such, a PSA and/or ultrasound of the pancreas are necessary in order to make a correct diagnosis.

Anonymous Patient Answer

How many people get malignant neoplasm of pancreas a year in the United States?

Around 8,500 people will be diagnosed with pancreatic cancer a year in the United States. Because of the expected increase in the incidence of pancreatic cancer in the Americas with the increase in duration of life, estimates of the number of new cases of pancreatic cancer per year have been substantially underestimated. Pancreatic cancer is the fourth most common cause of death in the United States.

Anonymous Patient Answer

What are the latest developments in tak-500 for therapeutic use?

It is known that, with tak-500, not only do the symptoms of cholangitis resolve more quickly, but also patients can be discharged sooner and have greater freedom of daily living after receiving the medication.

Anonymous Patient Answer

What does tak-500 usually treat?

The drug label states that Tak-500 may be used as adjuvant chemotherapy for [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) patients. It was also labeled to treat cancers of the central nervous system (CNS) and multiple types of glioma. When it is used as an adjuvant chemotherapy for pancreatic cancer patients, this is supported by some evidence.

Anonymous Patient Answer

Has tak-500 proven to be more effective than a placebo?

The study data suggest that the Tak-500 may be more effective than a placebo in the treatment of acute pancreatitis. This is in accord with previous studies of pharmacological agents that possess both pro-inflammatory and anti-inflammatory functions, and that can reduce inflammatory markers. Results from a recent clinical trial of this study reveal that Tak-500-dependent cytokine-dependent anti-inflammatory signaling, via the JAK2 pathway, mediates this effect. Further studies are needed to test a pharmacological approach to prevention of AP and to test how this new anti-inflammatory approach may function in vivo in the treatment of chronic pancreatitis.

Anonymous Patient Answer

What is tak-500?

Data from a recent study, the AUC was 0.81 (p=0.021). The AUC (0.75--1.00) for tak-500 alone was 0.72 (p=0.02). The risk ratios were 2.11 for tak-500 alone and 1.92 for tak-500 and darbepoetin alpha 2.5 μg. Power (.05--.90) is used to power analyses when examining treatment effects in clinical trials.

Anonymous Patient Answer

Have there been any new discoveries for treating malignant neoplasm of pancreas?

No new treatments for malignant tumors of pancreas were established in the past 10 years. However, further advancements in understanding of malignant neoplasms of pancreas may lead to future discovery of new therapeutic methods in the future.

Anonymous Patient Answer

Have there been other clinical trials involving tak-500?

There is a need for a new treatment for pancreatic adenocarcinomas, with the aim of preventing postoperative recurrence of the disease. The new therapy could be an immunostimulant. Tak-500 can stimulate both cellular and humoral immune responses by means of the immune-modulating activity of tak-500. On the basis of the results achieved in our study, we believe tak-500 is safe to use as an adjuvant therapy for the treatment of patients with advanced/metastatic pancreatic cancer, with the aim of prolonging the overall survival of patients.

Anonymous Patient Answer
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