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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Gastric Cancer

Q: How many candidates are being included in this clinical investigation?

Affirmative. According to information hosted on clinicaltrials.gov, this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial is currently searching for applicants. The study was initially posted on February 14th 2022 and the details have been modified most recently on September 22nd 2022. This research endeavour will be recruiting 15 individuals from a single medical site.

Q: What conditions have been treated through the utilization of Pembrolizumab?

Pembrolizumab is commonly used to combat malignant neoplasms, but it can also be utilized to tackle unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high cases and diseases that have worsened following chemotherapy.

Q: Is this experiment in progress and open to enlisting new participants?

Affirmative. Evidence on clinicaltrials.gov reveals that this trial, which was first published in February of 2022, is currently seeking participants. 15 patients will be recruited from one medical facility for the duration of this study.

Q: What earlier investigations have been conducted regarding the effectiveness of Pembrolizumab?

Currently, 1033 clinical studies are using Pembrolizumab as part of their intervention. Specifically, 134 of these investigations have reached the Phase 3 stage. Although most trials for this medication take place in Sacramento, <a href="https://www.withpower.com/clinical-trials/california">California</a>; 37099 sites across the world are running similar research projects.

Phase < 1

Recruiting

Led By Mariela Blum

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale within 5 days of starting study treatment

Male and female subjects who are at least 18 years of age with histologically and cytologically documented diagnosis as gastric or gastroesophageal adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial is testing pembrolizumab and lenvatinib to see if they can shrink or slow the growth of gastroesophageal adenocarcinoma.

Who is the study for?

This trial is for adults with advanced or metastatic gastroesophageal adenocarcinoma that's inoperable and hasn't responded to standard treatments. Participants must have acceptable organ function, controlled blood pressure, no major surgery within 3 weeks before the trial, not be pregnant or breastfeeding, and agree to use effective contraception.Check my eligibility

What is being tested?

The study tests pembrolizumab (an immunotherapy drug) combined with lenvatinib (a drug blocking enzymes needed by cancer cells). It aims to see if this combination can better attack the cancer and halt its growth compared to current methods.See study design

What are the potential side effects?

Potential side effects include immune system reactions affecting organs, high blood pressure due to lenvatinib, fatigue from both drugs, liver enzyme changes from pembrolizumab, and possibly other common chemotherapy-related issues like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I am 18 or older with a confirmed diagnosis of stomach or gastroesophageal cancer.

Select...

My kidney function is within the normal range.

Select...

My advanced stomach or esophagus cancer cannot be surgically removed and standard treatments have not worked.

Select...

I agree to follow the required contraception measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and lenvatinib PO QD, Treatment repeats every 42 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,787 Total Patients Enrolled

Mariela BlumPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

72 Total Patients Enrolled

Frequently Asked Questions

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

How many candidates are being included in this clinical investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, this experimental trial is currently searching for applicants. The study was initially posted on February 14th 2022 and the details have been modified most recently on September 22nd 2022. This research endeavour will be recruiting 15 individuals from a single medical site."

Answered by AI

What conditions have been treated through the utilization of Pembrolizumab?

"Pembrolizumab is commonly used to combat malignant neoplasms, but it can also be utilized to tackle unresectable melanoma, microsatellite instability high cases and diseases that have worsened following chemotherapy."

Answered by AI

Is this experiment in progress and open to enlisting new participants?

"Affirmative. Evidence on clinicaltrials.gov reveals that this trial, which was first published in February of 2022, is currently seeking participants. 15 patients will be recruited from one medical facility for the duration of this study."

Answered by AI

What earlier investigations have been conducted regarding the effectiveness of Pembrolizumab?

"Currently, 1033 clinical studies are using Pembrolizumab as part of their intervention. Specifically, 134 of these investigations have reached the Phase 3 stage. Although most trials for this medication take place in Sacramento, California; 37099 sites across the world are running similar research projects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

2022. "Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041153.

All > Esophagus Cancer > Gastric Cancer