Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER)

January 13, 2025 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Koto-ku, Japan, 135-8550
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taoyuan City, Taiwan, 333
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Texas
      • Houston, Texas, United States, 77090
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HNSCC Arm 1
Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC)
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Cisplatin (dose level 4)
IV
Radiation: External beam radiation (dose level 1)
radiation therapy
Experimental: NSCLC Arm 1
Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Etoposide (dose level 1)
IV
Radiation: External beam radiation (dose level 2)
radiation therapy
Drug: Cisplatin (dose level 1)
IV
Experimental: NSCLC Arm 2
Durvalumab + carboplatin and paclitaxel with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
Drug: Paclitaxel
IV
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Radiation: External beam radiation (dose level 2)
radiation therapy
Drug: Carboplatin (dose level 1)
IV
Experimental: NSCLC Arm 3
Investigator's choice of carboplatin and pemetrexed OR cisplatin and pemetrexed
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Radiation: External beam radiation (dose level 2)
radiation therapy
Drug: Carboplatin (dose level 2)
IV
Drug: Pemetrexed
IV
Drug: Cisplatin (dose level 2)
IV
Experimental: SCLC Arm 1
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Carboplatin (dose level 2)
IV
Drug: Cisplatin (dose level 3)
IV
Drug: Etoposide (dose level 2)
IV
Radiation: External beam radiation (standard)
radiation therapy
Experimental: SCLC Arm 2
Patients with limited-stage small-cell lung cancer (SCLC) should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Carboplatin (dose level 2)
IV
Drug: Cisplatin (dose level 3)
IV
Drug: Etoposide (dose level 2)
IV
Radiation: External beam radiation (hyperfractionated)
radiation therapy
Experimental: SCLC Arm 3
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin. Note: Arm 3 will only be opened if the regimen in SCLC Arm 1 is safe and tolerable.
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Carboplatin (dose level 2)
IV
Drug: Cisplatin (dose level 3)
IV
Drug: Etoposide (dose level 2)
IV
Radiation: External beam radiation (standard)
radiation therapy
Drug: Tremelimumab
IV
Experimental: SCLC Arm 4
Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin Note: Arm 4 will only be opened if the regimen in SCLC Arm 2 is safe and tolerable.
Drug: Durvalumab
IV (intravenous)
Other Names:
  • MEDI4736
Drug: Carboplatin (dose level 2)
IV
Drug: Cisplatin (dose level 3)
IV
Drug: Etoposide (dose level 2)
IV
Radiation: External beam radiation (hyperfractionated)
radiation therapy
Drug: Tremelimumab
IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subjects with Dose Limiting Toxicities (DLTs)
Time Frame: From first dose of durvalumab until 28 days after completion of radiation therapy
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
From first dose of durvalumab up to 90 days after the last dose of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
From first dose until death due to any cause through study completion, up to 4 years
Objective response rate (ORR)
Time Frame: From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years.
Number (%) of patients with an overall response of complete response (CR) or partial response (PR).
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)
Time Frame: From first dose until disease progression, or the last evaluable assessment in the absence of progression, assessed up to 4 years.
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.
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 Frame: From first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.
From first dose until disease progression, or death, in the absence of progression, assessed up to 4 years.
Disease control rate (DCR)
Time Frame: From first dose until disease progression, at 18 weeks and 48 weeks.
From first dose until disease progression, at 18 weeks and 48 weeks.
Disease-free survival (DFS)
Time Frame: From first dose until disease progression or death, in the absence of progression at 12, 18 and 24 months, assessed up to 4 years.
From first dose until disease progression or death, in the absence of progression at 12, 18 and 24 months, assessed up to 4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D933BC00001
  • 2017-002242-77 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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