Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02658214 | Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors | PHASE1 | COMPLETED | 32 | — | — | Apr 28, 2016 | Nov 14, 2019 | Aug 20, 2020 | 6 | Japan, South Korea |
To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab
To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab
To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)
| Arm | Type | Description |
|---|---|---|
| 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) |
| Cohort 6 | EXPERIMENTAL | Pancreatic ductal adenocarcinoma (PDAC) |
| Cohort 7 | EXPERIMENTAL | Esophageal squamous cell carcinoma (ESCC) |
| Name | Type | Description |
|---|---|---|
| paclitaxel + carboplatin | DRUG | IV infusion |
| 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 |
Inclusion Criteria: 1. ≥18 years 2. Written informed consent 3. Patients with histologically or cytologically documented chemotherapy-naïve locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC. 4. ECOG performance...