Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06860386
Phase
PHASE2
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg every 3 weeks IV infusion (Q3W + or -3 days)
  • Axitinib — DRUG
    5 mg twice daily (BID) by mouth

Study Details

This is a Phase II Clinical Trial that will evaluate the use of adaptive dosing of pembro-axi in patients with Metastatic Clear Cell Renal Cell Carcinoma (mccRCC).

Key Dates

First listed
Mar 6, 2025
Start date
Feb 25, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Feb 29, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adaptive Dosing pembro-axi
    In therapy naïve mccRCC patients, a standard dose of pembrolizumb will be given at 200 mg iv every 3 weeks, with axitinib given orally 5 mg twice daily. After 9 weeks, subjects will undergo the first response assessment as well as the therapy portion of the trial if they have 20% response per RECIST criteria. During adaptive dosing with pembro-axi, imaging is conducted every 9 weeks. Treatment is held until the tumor has returned to its baseline size or greater per RECIST 1.1, then restarted until a tumor reduction of at least 20% occurs. Therapy cycles on and off in this manner continue as the tumor shrinks and grows until confirmed progression of disease while on therapy.

Primary Outcome Measure

Recruitment Rate Feasibility [ Time Frame: Up to 36 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

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By research site
Moffitt Cancer Center· Tampa, FL

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