Loading clinical trials...

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER)

NCT03509012•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Detailed Description

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).

Eligibility

Age

18 - 110 years

Sex

ALL

Healthy Volunteers

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

Research Site

Kōtoku, Japan

Research Site

Sunto-gun, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Badalona, Spain

Key Dates

Start Date

May 2, 2018

Primary Completion Date

December 31, 2020

Completion Date

January 8, 2025

Last Updated

January 14, 2025

Enrollment

105

ACTUAL participants

Conditions

Carcinoma, Squamous Cell of Head and NeckCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Durvalumab

DRUG

Tremelimumab

DRUG

Cisplatin (dose level 4)

DRUG

Cisplatin (dose level 3)

DRUG

Carboplatin (dose level 1)

DRUG

Carboplatin (dose level 2)

DRUG

Etoposide (dose level 1)

DRUG

Etoposide (dose level 2)

DRUG

Paclitaxel

DRUG

Pemetrexed

DRUG

External beam radiation (dose level 1)

RADIATION

External beam radiation (dose level 2)

RADIATION

External beam radiation (hyperfractionated)

RADIATION

Cisplatin (dose level 1)

DRUG

Cisplatin (dose level 2)

DRUG

External beam radiation (standard)

RADIATION

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

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: January 14, 2025Data 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

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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

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