Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658214
• Other study ID #: D419SC00001
• Status: Completed
• Phase: Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Pancreatic Ductal
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Esophageal Squamous Cell Carcinoma
• Esophagogastric Junction Neoplasms
• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Small Cell Lung Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Stomach Neoplasms
• Triple Negative Breast Neoplasms

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)

External Links

•   Results of this clinical trial are available on www.astrazenecaclinicaltrials.com