Seleno-L Methionine (SLM) in Combination with Axitinib and Pembrolizumab for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa Hospitals & Clinics, Iowa City, IA
Carcinoma+3 More
Selenomethionine (SLM) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to test the safety and effectiveness of Seleno-L Methionine (SLM) when combined with the standard dose and schedule of Axitinib and Pembrolizumab in patients who have locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).

Eligible Conditions

  • Carcinoma
  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Clear Cell Renal Cell Carcinoma Metastatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: From the initiation of treatment through three years

From the initiation of treatment through three years
Overall survival (OS)
Phase I - Dose limiting toxicities using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Phase II - Objective Response Rate (ORR)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Seleno-L Methionine (SLM) in Combination with Axitinib and Pembrolizumab
1 of 1
Experimental Treatment

55 Total Participants · 1 Treatment Group

Primary Treatment: Seleno-L Methionine (SLM) in Combination with Axitinib and Pembrolizumab · No Placebo Group · Phase 1 & 2

Seleno-L Methionine (SLM) in Combination with Axitinib and PembrolizumabExperimental Group · 3 Interventions: Selenomethionine (SLM), Axitinib, Pembrolizumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
2013
Completed Phase 2
~3310
Pembrolizumab
2017
Completed Phase 3
~2950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the initiation of treatment through three years
Closest Location: University of Iowa Hospitals & Clinics · Iowa City, IA
Photo of Iowa City  1Photo of Iowa City  2Photo of Iowa City  3
2010First Recorded Clinical Trial
4 TrialsResearching Carcinoma
49 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a positive pregnancy test if you are over 18 years of age.
Liver function tests must be within institutional upper limits of normal for cases of liver metastases.
The absolute neutrophil count (ANC) is greater than 1.0 x 109/L.
You have at least one Response Evaluation Criteria in Solid Tumors (RECIST 1.
You have a creatinine level within normal institutional limit, or a creatinine clearance >15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.