Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04429321
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone
  • Ipilimumab — DRUG
    ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab
  • bland embolization — DEVICE
    Lipiodol:ethanol embolization of their primary or target tumor

Study Details

This single center phase 1 trial will study the combination of nivolumab+ipilimumab with embolization in participants with renal cell carcinoma. The study will evaluate the safety of embolotherapy in patients with metastatic RCC receiving nivolumab+ipilimumab. The hypothesis is that the number of serious adverse events will be no greater than the number of serious adverse events for both therapies combined.

Key Dates

Start date
Aug 26, 2020
Status verified
Apr 2024
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab +Nivolumab with Embolization
    Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities. Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.

Primary Outcome Measure

Rate of serious adverse events [ Time Frame: Serious adverse events will be recorded from time of informed to consent to 100 days after the end of study intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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