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Completed

NCT Number: NCT03509012

Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

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

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Key information

Conditions

Carcinoma, Squamous Cell of Head and Neck Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Kōtoku, Japan

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Durvalumab

Drug

IV (intravenous)

Other names: MEDI4736

Tremelimumab

Drug

IV

Cisplatin (dose level 4)

Drug

IV

Cisplatin (dose level 3)

Drug

IV

Carboplatin (dose level 1)

Drug

IV

Carboplatin (dose level 2)

Drug

IV

Etoposide (dose level 1)

Drug

IV

Etoposide (dose level 2)

Drug

IV

paclitaxel

Drug

IV

Pemetrexed

Drug

IV

External beam radiation (dose level 1)

Radiation

radiation therapy

External beam radiation (dose level 2)

Radiation

radiation therapy

External beam radiation (hyperfractionated)

Radiation

radiation therapy

Cisplatin (dose level 1)

Drug

IV

Cisplatin (dose level 2)

Drug

IV

External beam radiation (standard)

Radiation

radiation therapy

Primary outcomes

  1. Number of subjects with Dose Limiting Toxicities (DLTs)

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

  2. 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

  1. 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.

  2. Overall Survival (OS)

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

  3. 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).

  4. 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.

  5. 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.

  6. Disease control rate (DCR)

    Time frame: From first dose until disease progression, at 18 weeks and 48 weeks.

  7. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CLOVER

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Apr 26, 2018
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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