Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)
Part of paid clinical trials in Goodyear, Arizona.
- Sponsor
- Western Regional Medical Center
- Study ID
- NCT02423954
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- Advanced Cancer
- Colorectal Carcinoma
- Endometrial
- Non Small Cell Lung Cancer
- Pancreatic Cancer
- Renal Cell Cancer
- Uterine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Temsirolimus — DRUG
- Irinotecan — DRUG
- Irinotecan + capecitabine — DRUG
- nivolumab — DRUG
Study Details
Determine Phase 2 dose of study drug
Key Dates
- Start date
- Apr 30, 2015
- Status verified
- Jun 2018
- Primary completion
- Nov 1, 2017
- Completion
- Nov 1, 2017
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1Temsirolimus 25 mg every 14 days + nivolumab
- Experimental: Arm 2Irinotecan 150 mg/m2 every 14 days + nivolumab
- Experimental: Arm 3Irinotecan + capecitabine + nivolumab irinotecan 175 mg/m2 on day 1 every 14 days + capecitabine 1000 mg PO BID days 1-5 on, days 6-7 off, each 7 day period
Primary Outcome Measure
The recommended phase 2 dose (RP2D) of chemotherapy in combination with nivolumab in subjects with advanced cancer. [ Time Frame: up to 4 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cancer Treatment Center of America @ Western Regional Medical Center | Goodyear | Arizona | 85338 | - |
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