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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223710

Enrollment

Registered

2017-11-10

Start date

2017-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

investigational material(s) Generic name etc : Cohort 1 Drug: paclitaxel + carboplatin, durvalumab, tremelimumab INN of investigational material : - Therapeutic category code : 429 Other antitumor ag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. more than 18 years ( 20 years and more in Japan) 2. Written informed consent 3. Patients with histologically or cytologically documented chemotherapy-naive locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC. 4. ECOG performance status of 0 or 1 5. Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease 6. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline 7. No prior exposure to immune-mediated therapy 8. Adequate organ and marrow function as defined below

Exclusion criteria

Exclusion criteria: 1. Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment 2. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment 3. Any unresolved Grade more than 2 toxicity from previous anticancer therapy 4. Active or prior documented autoimmune or inflammatory disorders 5. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent 6. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) more than 470 ms 20. Active tuberculosis 7. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

Design outcomes

Primary

Measure	Time frame
safety -	—

Secondary

Measure	Time frame
other -	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026