Phase I/II Study of Seleno-L Methionine (SLM) in Sequential Combination With Fixed Doses and Schedules of Axitinib and Pembrolizumab (SAP) in Locally Advanced and Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ To be eligible to participate in this study, an individual must meet all the following criteria:

• Written and voluntary informed consent.

• Histologically and radiologically confirmed locally advanced or metastatic ccRCC. Locally advanced is defined as non resectable in the opinion of the treating providers. Participants must be treatment naïve in metastatic setting. Prior immunotherapy treatment in adjuvant setting is allowed.

• \> 18 years of age

• At least one Response Evaluation Criteria in Solid Tumors (RECIST 1.1)-defined target lesion that has not been irradiated

• Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work).

• Renal function (creatinine level within normal institutional limit, or creatinine clearance \>15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).

• 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.)

• Adequate hematological lab values including

‣ Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L

⁃ Platelets ≥ 100 x 109/L

⁃ Hemoglobin ≥ 7.0 g/dL

• Has adequately controlled BP with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week before randomization/allocation.

• 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.

Locations
United States
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Contact Information
Primary
Bilal Rahim, MD
bilal-rahim@uiowa.edu
319-353-8155
Backup
Janelle Born, RN
janelle-born@uiowa.edu
319-356-4797
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 55
Treatments
Experimental: Seleno-L Methionine (SLM) in Combination with Axitinib and Pembrolizumab
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.
Related Therapeutic Areas
Sponsors
Leads: Mohammed Milhem
Collaborators: University of Iowa

This content was sourced from clinicaltrials.gov