Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib

Sponsor
University of Oklahoma
Study ID
NCT05263609
Phase
PHASE2
Status
Withdrawn

Conditions

  • Renal Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Axitinib — DRUG
    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).
  • Pembrolizumab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jun 30, 2022
Status verified
Jul 2022
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Arm A (CR/oPR on pembrolizumab monotherapy): Patients will continue pembrolizumab monotherapy if CR/oPR on initial treatment with pembrolizumab monotherapy. If CR/oPR persists at 8 cycles (24 weeks) after assignment on arm A, pembrolizumab break will commence. Patients will be monitored for disease progression with imaging every 9 weeks (+/- 1 week). If patients develop progression, pembrolizumab will be resumed and continued until subsequent PD. At that point, axitinib may be added to pembrolizumab as part of the study or patients may discontinue study treatment per the treating investigator's discretion.
  • Experimental: Arm B
    Arm B (sPR/SD/PD): Patients with sPR, SD or PD after 6 cycles of pembrolizumab monotherapy will be started on axitinib in addition to continuing pembrolizumab. If patients develop subsequent PD, treatment will be discontinued. If the subsequent scans show SD/PR/CR, the combination treatment will be continued until PD or unacceptable toxicity.

Primary Outcome Measure

Proportion of Patient Response [ Time Frame: 2 year ]

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