Clinical trial · Interventional
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)
NCT03509012CI-TRIAL-00084662CLOVERcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin (dose level 1) | Drug | Carboplatin | ALIAS |
| Carboplatin (dose level 2) | Drug | Carboplatin | ALIAS |
| Cisplatin (dose level 1) | Drug | Cisplatin | ALIAS |
| Cisplatin (dose level 2) | Drug | Cisplatin | ALIAS |
| Cisplatin (dose level 3) | Drug | Cisplatin | ALIAS |
| Cisplatin (dose level 4) | Drug | Cisplatin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Etoposide (dose level 1) | Drug | Etoposide |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- HNSCC Arm 1
- description
- Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC)
- interventionNames
- Drug: Durvalumab
- Drug: Cisplatin (dose level 4)
- Radiation: External beam radiation (dose level 1)
- type
- EXPERIMENTAL
- label
- NSCLC Arm 1
- description
- Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
- interventionNames
- Drug: Durvalumab
- Drug: Etoposide (dose level 1)
- Radiation: External beam radiation (dose level 2)
- Drug: Cisplatin (dose level 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.