PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer

Sponsor
HealthPartners Institute
Study ID
NCT03927248
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    See description in Arms/Groups section

Study Details

The primary objective of the pilot study is to determine activity of PAC-1 and nivolumab combination in subjects with metastatic renal cell carcinoma previously treated with immune checkpoint inhibitor therapy as assessed by objective response rate (ORR) using RECIST 1.1 criteria.

Key Dates

Start date
Sep 30, 2020
Status verified
Apr 2020
Primary completion
Sep 30, 2021
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Nivolumab and PAC-1
    Patient will be accrued and started on dose 1 level of PAC-1 (500 mg). If no DLT is observed in first cycle of therapy (28 days), dose of PAC-1 will be escalated to 625 mg in second cycle of therapy for the same patient. If patient remains on study and has no dose limiting toxicities, then in third cycle, dose will be escalated to 750 mg and continue in following cycles, if no dose adjustment is needed because of toxicities. Nivolumab will be administered by IV infusion at a dose of 480 mg.

Primary Outcome Measure

To determine activity of PAC-1 and nivolumab [ Time Frame: 12 months ]

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