High Dose IL-2 in Combination With Anti-PD-1

Part of paid clinical trials in La Jolla, California.

Sponsor
Gregory Daniels
Study ID
NCT03991130
Phase
PHASE2
Status
Terminated

Conditions

  • Melanoma
  • Renal Cell Carcinoma, Metastatic

Eligibility Criteria

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

Interventions

  • IL-2 and Nivolumab — DRUG
    Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.

Study Details

The primary objective of this single arm phase 2 trial is to assess the response rate \[complete response (CR) + partial response (PR)\] of combined nivolumab and HD IL-2 in subjects with metastatic melanoma and renal cell carcinoma. Response will be performed after each course of nivolumab and IL-2 using RECIST 1.1. Patients will be treated for one course past best response for a maximum of 3 courses.

Key Dates

First listed
Jun 19, 2019
Start date
Jul 17, 2019
Status verified
Jul 2026
Primary completion
Feb 7, 2023
Completion
Aug 16, 2024

Study Design

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

Arms

  • Experimental: High Dose IL-2 and Nivolumab

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 45 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-

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By research site
UC San Diego Moores Cancer Center· La Jolla, CA

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