Trials / Completed
CompletedNCT02989714
Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab. Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate, complete response rate, and improved survival outcomes compared to either of the individual therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Interleukin-2 | 600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart |
| DRUG | Nivolumab | Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression |
Timeline
- Start date
- 2017-03-16
- Primary completion
- 2019-02-25
- Completion
- 2020-06-23
- First posted
- 2016-12-12
- Last updated
- 2021-07-13
- Results posted
- 2020-03-09
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02989714. Inclusion in this directory is not an endorsement.