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.
1 other identifier
interventional
32
2 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2016
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedStudy Start
First participant enrolled
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2019
CompletedAugust 20, 2020
August 1, 2020
3.5 years
January 11, 2016
August 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Study Arms (7)
Cohort 1
EXPERIMENTALovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN)
Cohort 2
EXPERIMENTALSmall-cell lung cancer (SCLC)
Cohort 3
EXPERIMENTALTriple-negative breast cancer (TNBC)
Cohort 4
EXPERIMENTALTriple-negative breast cancer (TNBC)
Cohort 5
EXPERIMENTALGastric/gastro-esophageal junction (GEJ)
Cohort 6
EXPERIMENTALPancreatic ductal adenocarcinoma (PDAC)
Cohort 7
EXPERIMENTALEsophageal squamous cell carcinoma (ESCC)
Interventions
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion and bolus administration
IV infusion
IV infusion
IV infusion
Eligibility Criteria
You may qualify if:
- ≥18 years
- Written informed consent
- 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.
- ECOG performance status of 0 or 1
- Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
- At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
- No prior exposure to immune-mediated therapy
- Adequate organ and marrow function as defined below
You may not qualify if:
- Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
- 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
- Any unresolved Grade ≥2 toxicity from previous anticancer therapy
- Active or prior documented autoimmune or inflammatory disorders
- 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
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms 20. Active tuberculosis
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Chūōku, 104-0045, Japan
Research Site
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
Related Publications (1)
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.
PMID: 37489066DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 18, 2016
Study Start
April 28, 2016
Primary Completion
November 14, 2019
Study Completion
November 14, 2019
Last Updated
August 20, 2020
Record last verified: 2020-08