Trials / Terminated
TerminatedNCT04173325
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Augusta University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer. |
| DRUG | Irinotecan Injection [Camptosar] | Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer. |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2022-05-26
- Completion
- 2022-05-26
- First posted
- 2019-11-21
- Last updated
- 2022-06-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04173325. Inclusion in this directory is not an endorsement.