CLOVER

Phase 1

Suspended

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

• Registration Number: JPRN-jRCT2080223930
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: suspended
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: Interventional
• Study Design: Not specified