Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer
Phase 2
Active, not recruiting
NCT02888743
| Condition | Metastatic Colorectal Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage IV Colorectal Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7 |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 110 participants |
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| Interventions | Durvalumab, Radiation Therapy, Tremelimumab |
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| Start date | Aug 14, 2017 |
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| Completion date | Dec 31, 2023 |
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| Results posted | Jun 25, 2024 |
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Summary
This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body (metastatic). Immunotherapy with durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.
Overall Response Rate
Up to 2 years · Participants
| NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) | 3 Participants |
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| NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) | 2 Participants |
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| NSCLC Arm C (Tremelimumab, Durvalumab) | 3 Participants |
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| CRC Arm A (Tremelimumab, Durvalumab, HD-RT) | 0 Participants |
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| CRC Arm B (Tremelimumab, Durvalumab, LD-RT) | 0 Participants |
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| p-value | 0.99 |
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| Difference between proportions | 0.0 (95% CI -14.6–14.6) |
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Open in BENITIONS
View on ClinicalTrials.gov
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