Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

AstraZeneca105 enrolled

Overview

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

This study will initially treat up to approximately 300 patients with advanced solid tumors at approximately 30 sites, worldwide. The study will be composed of a dose-limiting toxicity (DLT) assessment phase (Part A) and an expansion phase (Part B).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Carcinoma, Squamous Cell of Head and Neck Carcinoma, Non-Small-Cell Lung Small Cell Lung Carcinoma

Interventions

DurvalumabDRUG

IV (intravenous)

TremelimumabDRUG

Cisplatin (dose level 4)DRUG

Cisplatin (dose level 3)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

Inclusion criteria: * World Health Organization (WHO)/ECOG performance status of 0 or 1 * Body weight \>30 kg at enrollment and treatment assignment * At least 1 measurable lesion, not previously irradiated * No prior exposure to immune-mediated therapy (including therapeutic anticancer vaccines) * For patients with oropharyngeal HNSCC HPV status has to be known Exclusion criteria: * Patients with simultaneous primary malignancies or bilateral tumors * Active or prior documented autoimmune or inflammatory disorders * Brain metastases or spinal cord compression * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies) * Has a paraneoplastic syndrome (PNS) of autoimmune nature * HNSCC cohort: Head and neck cancer that does not include unresectable, locally advanced cancer of oral cavity, larynx, oropharynx or hypopharynx. HNSCC of unknown primary are also excluded * NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology * SCLC cohort: Extensive-stage SCLC

Locations (16)

Research Site

Tucson, Arizona, United States

Research Site

Aurora, Colorado, United States

Research Site

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of subjects with Dose Limiting Toxicities (DLTs)

Time frame: From first dose of durvalumab until 28 days after completion of radiation therapy

Number of subjects with Adverse Events (AEs)

Time frame: From first dose of durvalumab up to 90 days after the last dose of study treatment

Secondary Outcomes

Progression-free survival (PFS)

Time frame: From first dose until the date of objective disease progression or death, in the absence of progression at 12, 18 and 24 months, up to 4 years.

Overall Survival (OS)

Time frame: From first dose until death due to any cause through study completion, up to 4 years

Objective response rate (ORR)

Number (%) of patients with an overall response of complete response (CR) or partial response (PR).

Time frame: From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years.

Best objective response (BoR)

The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression.

Time frame: From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years.

Duration of response (DoR)

Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.

Time frame: From first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.

Data from ClinicalTrials.gov

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