NCT03509012CompletedPhase 1
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)
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 12 Mar 2018
- Start date
- 2 May 2018
- Primary completion date
- 31 Dec 2020
- Lead sponsor
- AstraZeneca
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT03509012
- EudraCT number
- 2017-002242-77
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 105
- From 2 May 2018 to the primary completion date, 31 Dec 2020
- 12 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune or inflammatory disorders
Other illness
- Patients with simultaneous primary malignancies or bilateral tumors
- 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
Other
- Brain metastases or spinal cord compression
- NSCLC and SCLC cohort: Mixed SCLC and NSCLC histology
- SCLC cohort: Extensive-stage SCLC
Who the study is looking for
- 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
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sunto-gun | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.