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Monoclonal Antibodies

Pembrolizumab + Sunitinib for Thymic Cancer

Phase 2

Recruiting

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

Must not have

Received prior sunitinib or pembrolizumab therapy

Known history of active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with sunitinib or pembrolizumab before.

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I have an active case of tuberculosis.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I am currently being treated for an infection.

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I have not had a clot in my arteries in the last 6 months.

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I have a heart rhythm problem that is moderate to severe.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have a serious wound or fracture that is not healing.

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I have not received a live vaccine in the last 30 days.

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My cancer has spread to my brain or its coverings.

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I am using or might need strong medication that affects liver enzymes.

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I am not allergic to pembrolizumab or sunitinib.

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I have had severe bleeding in the last 4 weeks.

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I have another cancer that is getting worse or needs treatment.

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I have a history of HIV or active hepatitis B or C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 study objectives

PD-L1 by immunohistochemistry

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Sunitinib Malate

2008

Completed Phase 3

~3070