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Tyrosine Kinase Inhibitor

SLM-Axitinib-Pembrolizumab for Renal Cell Carcinoma

Phase 1 & 2

Recruiting

Led By Bilal Rahim, MD

Research Sponsored by Bilal G. Rahim

Eligibility Criteria Checklist

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

Must have

Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from the time of screening, throughout the total duration of the drug treatment, and during the 6 month post-drug washout period. See section 5.6 for full details

Liver function (AST/ALT <3.0 X institutional upper limit of normal OR < 5 x institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN)

Must not have

Major surgery within 4 weeks of starting study treatment

Untreated metastases in the central nervous system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initiation of treatment through three years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it is safe and effective for patients with advanced kidney cancer.

Who is the study for?

This trial is for adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who haven't been treated for it in the metastatic setting. They must be physically active or able to do light work, have normal organ function, controlled blood pressure, and agree to use effective contraception. Those with other cancers, untreated brain metastases, recent major surgery, HIV/AIDS complications, or needing certain drugs are excluded.

What is being tested?

The study tests the safety and effectiveness of Seleno-L Methionine (SLM) combined with standard doses of Axitinib and Pembrolizumab in treating ccRCC. It aims to see if adding SLM improves outcomes compared to just Axitinib and Pembrolizumab.

What are the potential side effects?

Possible side effects include typical reactions from cancer treatments such as fatigue, nausea, liver issues; immune-related conditions due to Pembrolizumab; high blood pressure from Axitinib; plus any unique effects from combining these with SLM.

Eligibility Criteria

Inclusion Criteria

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

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I agree to use effective birth control during and 6 months after the study.

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My liver tests are within the required limits, even with liver metastases.

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I can do my usual activities or light work but not heavy physical tasks.

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

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I am older than 18 years.

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I have a tumor that can be measured and hasn't been treated with radiation.

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My blood pressure is ≤150/90 mm Hg and stable on my current medication.

Exclusion Criteria

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

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I have not had major surgery in the last 4 weeks.

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I have untreated brain or spinal cord metastases.

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I have HIV and have had serious infections because of it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of treatment through three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of treatment through three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of treatment through three years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I - Dose limiting toxicities using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Phase II - Objective Response Rate (ORR)

Secondary study objectives

Overall survival (OS)

Progression-free survival (PFS)

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: Seleno-L Methionine (SLM) in Combination with Axitinib and PembrolizumabExperimental Treatment3 Interventions

SLM only will be taken by mouth during a two-week run in period. Then patients will receive SLM and Axitinib drugs by mouth, and Pembrolizumab intravenously (IV), at the start of each 21 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Axitinib

2020

Completed Phase 2

~3050