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Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

NCT02658214•AstraZeneca

View on ClinicalTrials.gov

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.

Detailed 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).

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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)

Locations (6)

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Key Dates

Start Date

April 28, 2016

Primary Completion Date

November 14, 2019

Completion Date

November 14, 2019

Last Updated

August 20, 2020

Enrollment

ACTUAL participants

Conditions

Small Cell Lung CarcinomaCarcinoma, Squamous Cell of Head and NeckStomach NeoplasmsTriple Negative Breast NeoplasmsOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsEsophagogastric Junction NeoplasmsCarcinoma, Pancreatic DuctalEsophageal Squamous Cell Carcinoma

Interventions

paclitaxel + carboplatin

DRUG

carboplatin + etoposide

DRUG

gemcitabine + carboplatin

DRUG

nab-paclitaxel (paclitaxel-albumin) + carboplatin

DRUG

oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)

DRUG

durvalumab

BIOLOGICAL

tremelimumab

BIOLOGICAL

nab-paclitaxel (paclitaxel-albumin) + gemcitabine

DRUG

cisplatin + 5-fluorouracil (5FU)

DRUG

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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RECRUITINGPHASE1

A Study of LY4175408 in Participants With Advanced Cancer

NCT07046923

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study of LY4175408 in Participants With Advanced Cancer

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain

A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer