Trials / Completed
CompletedNCT02658214
Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.
Detailed description
7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab. This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC) and esophageal squamous cell carcinoma (ESCC).
Conditions
- Small Cell Lung Carcinoma
- Carcinoma, Squamous Cell of Head and Neck
- Stomach Neoplasms
- Triple Negative Breast Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Esophagogastric Junction Neoplasms
- Carcinoma, Pancreatic Ductal
- Esophageal Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel + carboplatin | IV infusion |
| DRUG | carboplatin + etoposide | IV infusion |
| DRUG | gemcitabine + carboplatin | IV infusion |
| DRUG | nab-paclitaxel (paclitaxel-albumin) + carboplatin | IV infusion |
| DRUG | oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) | IV infusion and bolus administration |
| BIOLOGICAL | durvalumab | IV infusion |
| BIOLOGICAL | tremelimumab | IV infusion |
| DRUG | nab-paclitaxel (paclitaxel-albumin) + gemcitabine | IV infusion |
| DRUG | cisplatin + 5-fluorouracil (5FU) | IV infusion |
Timeline
- Start date
- 2016-04-28
- Primary completion
- 2019-11-14
- Completion
- 2019-11-14
- First posted
- 2016-01-18
- Last updated
- 2020-08-20
Locations
6 sites across 2 countries: Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02658214. Inclusion in this directory is not an endorsement.