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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02658214
Other study ID # D419SC00001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 28, 2016
Est. completion date November 14, 2019

Study information

Verified date August 2020
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 14, 2019
Est. primary completion date November 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 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:

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 =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) =470 ms 20. Active tuberculosis

7. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
paclitaxel + carboplatin
IV infusion
carboplatin + etoposide
IV infusion
gemcitabine + carboplatin
IV infusion
nab-paclitaxel (paclitaxel-albumin) + carboplatin
IV infusion
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
IV infusion and bolus administration
Biological:
durvalumab
IV infusion
tremelimumab
IV infusion
Drug:
nab-paclitaxel (paclitaxel-albumin) + gemcitabine
IV infusion
cisplatin + 5-fluorouracil (5FU)
IV infusion

Locations

Country Name City State
Japan Research Site Chuo-ku
Japan Research Site Kashiwa
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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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