NCT05263609

Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib

Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib in Metastatic Renal Cell Cancer: A Response Adapted Study (OPTIMAX)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test the response of study participants' tumor to pembrolizumab alone, and in combination with axitinib, and to see what effects (good and bad) these drugs have on patients with advanced kidney cancer.

Detailed description

Patients will receive infusions of pembrolizumab. After an MRI or CT scan to determine how the tumor is responding to the drug, the patient will either continue receiving infusions of pembrolizumab alone, or receive axitinib in addition to pembrolizumab. The patient will also need to provide a biopsy of your tumor around the time the imaging scan is taken and need to come to the clinic around every three weeks during treatment. At the clinic visits, we will also do lab tests and imaging.

Conditions

• Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Axitinib	If pembrolizumab infusions alone do not reduce the patient's tumor size by at least 60%,the patient will be placed in Arm B and start axitinib in addition to continuing pembrolizumab therapy (see Arm B).
DRUG	Pembrolizumab	If pembrolizumab results in a reduction in tumor size that is greater than 60%, the patient will be placed in Arm A and continue pembrolizumab infusions (see Arm A).

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2022-03-02
• Last updated: 2022-08-02

Regulatory

• FDA-regulated drug study