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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN) |
|
| Cohort 2 | Experimental | Small-cell lung cancer (SCLC) |
|
| Cohort 3 | Experimental | Triple-negative breast cancer (TNBC) |
|
| Cohort 4 | Experimental | Triple-negative breast cancer (TNBC) |
|
| Cohort 5 | Experimental | Gastric/gastro-esophageal junction (GEJ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel + carboplatin | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory findings (including: clinical chemistry, hematology, and urinalysis) | To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab | Throughout the study, approximately three years |
| Incidence of Adverse Events | To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab | Throughout the study, approximately three years |
| Tumor assessment based on RECIST 1.1 (for cohort 6 only) | To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only) | Throughout the study, approximately three years (for cohort 6 only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chūōku | 104-0045 | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37489066 | Derived | Lee DH, Kim HR, Keam B, Kato K, Kuboki Y, Gao H, Yovine A, Robbins SH, Ahn MJ. Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma. Cancer Med. 2023 Aug;12(15):16066-16075. doi: 10.1002/cam4.6260. Epub 2023 Jul 25. |
| Label | URL |
|---|---|
| Results of this clinical trial are available on www.astrazenecaclinicaltrials.com | View source |
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| Cohort 6 | Experimental | Pancreatic ductal adenocarcinoma (PDAC) |
|
| Cohort 7 | Experimental | Esophageal squamous cell carcinoma (ESCC) |
|
| carboplatin + etoposide | Drug | IV infusion |
|
|
| gemcitabine + carboplatin | Drug | IV infusion |
|
|
| nab-paclitaxel (paclitaxel-albumin) + carboplatin | Drug | IV infusion |
|
|
| oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid) | Drug | IV infusion and bolus administration |
|
|
| durvalumab | Biological | IV infusion |
|
|
| tremelimumab | Biological | IV infusion |
|
| nab-paclitaxel (paclitaxel-albumin) + gemcitabine | Drug | IV infusion |
|
|
| cisplatin + 5-fluorouracil (5FU) | Drug | IV infusion |
|
|
| Kashiwa |
| 277-8577 |
| Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D013274 | Stomach Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D021441 | Carcinoma, Pancreatic Ductal |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D004935 | Esophageal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C053518 | CP protocol |
| C098534 | EC regimen |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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