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Monoclonal Antibodies

Pembrolizumab + Sunitinib for Thymic Cancer

Phase 2

Waitlist Available

Led By Dwight Owen, MD

Research Sponsored by Dwight Owen

Eligibility Criteria Checklist

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

Must have

Ability to swallow and retain oral medication

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is studying pembrolizumab and sunitinib malate to treat thymic cancer.

Who is the study for?

This trial is for adults with advanced thymic cancer that has spread or can't be surgically removed and hasn't responded to platinum-based chemotherapy. Participants must have a life expectancy over 3 months, stable blood pressure, adequate organ function, no severe active infections or autoimmune diseases, not pregnant or breastfeeding, and willing to use contraception.Check my eligibility

What is being tested?

The study tests pembrolizumab (a monoclonal antibody) combined with sunitinib malate (an enzyme inhibitor) on participants with refractory metastatic or unresectable thymic cancer. It aims to see if this combination better inhibits tumor growth compared to current treatments.See study design

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, fatigue, digestive issues such as nausea and diarrhea, skin rash, liver problems indicated by abnormal blood tests results and potential risks of high blood pressure due to sunitinib.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow and keep down pills.

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

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My blood pressure is under control.

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My kidney function, measured by creatinine or GFR, is within the normal range.

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My thymic carcinoma is advanced and cannot be cured with treatment.

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My cancer has worsened after receiving platinum-based chemotherapy.

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I am willing to undergo a biopsy for my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Response defined by a complete response (CR) or partial response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary outcome measures

Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Overall survival (OS)

Progression free survival (PFS)

Other outcome measures

PD-L1 by immunohistochemistry

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, sunitinib malate)Experimental Treatment3 Interventions

Participants receive pembrolizumab IV over 30 minutes on day 1 and sunitinib malate PO daily on days 1-14. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Sunitinib Malate

2008

Completed Phase 3

~3070

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dwight OwenLead Sponsor

4 Previous Clinical Trials

159 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,637 Total Patients Enrolled

9 Trials studying Thymic Carcinoma

969 Patients Enrolled for Thymic Carcinoma

Dwight Owen, MDPrincipal Investigator - Ohio State University Comprehensive Cancer Center

OSU Harding Hospital, Ohio State University Hospital - Wexner Medical Center, Richard M. Ross Heart Hospital

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03463460 — Phase 2

Thymic Carcinoma Research Study Groups: Treatment (pembrolizumab, sunitinib malate)

Thymic Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03463460 — Phase 2

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03463460 — Phase 2

Frequently Asked Questions

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

Is enrollment in this research endeavor currently open?

"Affirmative. Clinicaltrials.gov verifies that the trial, which was first launched on June 19th 2018, is presently in need of participants. In total, 40 patients will be enrolled from 3 clinical centres."

Answered by AI

What is the recruitment rate of this medical trial?

"Forty potential candidates that meet the predefined criteria must join this research initiative. Participants can register at one of two medical centres; Indiana University in Indianapolis, IN and Ohio State University Comprehensive Cancer Center in Columbus, OH."

Answered by AI

Has Pembrolizumab gained authorization from the Food and Drug Administration?

"Pembrolizumab's safety is rated as a 2 due to limited evidence suggesting its efficacy, though there has been data collected supporting the drug's safety."

Answered by AI

To what diseases is Pembrolizumab typically prescribed?

"Pembrolizumab is often prescribed for cancerous neoplasms, and can also be utilized to address unresectable melanoma, microsatellite instability high, as well as cases with a heightened risk of relapse."

Answered by AI

Have any past experiments involved the use of Pembrolizumab?

"Pembrolizumab was investigated for the first time in 2006 at DuPage Medical Group - Joliet. Since then, 1041 studies have been completed and 988 are presently ongoing; many of them taking place in Indianapolis, Indiana."

Answered by AI