Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT02983578
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Advanced Colorectal Carcinoma
- Advanced Lung Non-Small Cell Carcinoma
- Lung Non-Small Cell Carcinoma
- Mismatch Repair Deficiency
- Refractory Colorectal Carcinoma
- Refractory Lung Carcinoma
- Refractory Pancreatic Carcinoma
- Stage II Pancreatic Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Danvatirsen — DRUGGiven IV
- Durvalumab — BIOLOGICALGiven IV
Study Details
This phase II trial studies how well danvatirsen and durvalumab work in treating patients with pancreatic cancer, non-small cell lung cancer and mismatch repair deficient colorectal cancer that has spread to other places in the body and does not respond to treatment. Danvatirsen may be used to block the production of proteins needed for tumor cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving danvatirsen and durvalumab may work better at treating pancreatic cancer, non-small cell lung cancer and mismatch repair deficient colorectal cancer.
Key Dates
- Start date
- Mar 2, 2017
- Status verified
- May 2025
- Primary completion
- Aug 30, 2025
- Completion
- Aug 30, 2025
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (danvatirsen, durvalumab)Patients receive danvatirsen IV over 1 hour on days 7, 5 and 3 prior to cycle 1, then on days 1, 8, 15 and 22. Patients also receive durvalumab IV over 1 hour on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Incidence of adverse events (AEs), serious AEs [ Time Frame: Up to 4 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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