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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Neuroendocrine Cancer

Phase 2

Waitlist Available

Led By Jonathan Strosberg, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

Study Summary

This trial will study how well pembrolizumab and lenvatinib work together to treat patients with solid tumors that have progressed despite standard treatment. Researchers will also study the safety and side effects of the combination therapy.

Who is the study for?

Adults with advanced well-differentiated neuroendocrine tumors of the lung, thymus, small bowel, or colorectum (or unknown primary) that have worsened recently. They must have tried at least two other treatments unless they were adjuvant/neoadjuvant therapies completed within a year. Participants need to be in good physical condition and not pregnant or breastfeeding. They can't join if they've had certain recent illnesses, used specific drugs, or are on immunosuppressants.Check my eligibility

What is being tested?

The trial is testing how safe and effective Pembrolizumab combined with Lenvatinib is for treating these types of tumors by looking at tumor response rates and how long patients live without their disease getting worse.See study design

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, fatigue, digestive issues like nausea or diarrhea, skin problems such as rash or itching, liver function changes, high blood pressure and risks related to wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Radiographic Response Rate (ORR)

Secondary outcome measures

Duration of Response (DOR)

Overall Survival (OS)

Progression Free Survival (PFS)

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: Pembrolizumab & Lenvatinib treatmentExperimental Treatment2 Interventions

Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks, in addition to 20 mg Lenvatinib by mouth every day of each 3 week cycle. Estimated average length of treatment per participant: 4 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Lenvatinib

2005

Completed Phase 4

~2690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,475 Total Patients Enrolled

8 Trials studying Neuroendocrine Tumors

293 Patients Enrolled for Neuroendocrine Tumors

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,059,915 Total Patients Enrolled

12 Trials studying Neuroendocrine Tumors

2,172 Patients Enrolled for Neuroendocrine Tumors

Jonathan Strosberg, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

7 Previous Clinical Trials

189 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

156 Patients Enrolled for Neuroendocrine Tumors

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03290079 — Phase 2

Neuroendocrine Tumors Research Study Groups: Pembrolizumab & Lenvatinib treatment

Neuroendocrine Tumors Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT03290079 — Phase 2

Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03290079 — Phase 2

Frequently Asked Questions

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

What past research exists on Pembrolizumab?

"Pembrolizumab is being trialled in 1076 active studies, 134 of which are in Phase 3. Many trials for Pembrolizumab are running concurrently in Sacramento, California, but there are also 37375 other locations around the world where the medication is being tested."

Answered by AI

Are new participants still being accepted into this research project?

"Currently, this clinical trial is not enrolling patients. The study was first made public on December 15th, 2017 and has since been updated November 15th, 2022. However, there are 232 other trials for neuroendocrine tumors and 1076 Pembrolizumab trials recruiting participants at this time."

Answered by AI

How many people are signing up to participate in this research?

"Recruitment for this study has ended. The trial was posted on December 15th, 2017 and last updated on November 15th, 2022. There are currently 232 clinical trials recruiting patients with neuroendocrine tumors and 1076 trials recruiting patients for Pembrolizumab."

Answered by AI

What are the principle indications for Pembrolizumab?

"Pembrolizumab is an approved treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How does Pembrolizumab's safety profile look?

"Pembrolizumab is still being researched in Phase 2 trials, so there is not enough evidence to support its efficacy. However, data collected thus far suggests that it may be safe for use and it received a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors

2017. "Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03290079.

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