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Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib

NCT05263609 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-08-02

No results posted yet for this study

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.

Conditions

  • Renal Cell Cancer

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Abhishek Tripathi, MD · Stephenson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05263609 on ClinicalTrials.gov