Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors - CLOVER
Study identifier:D933BC00001
ClinicalTrials.gov identifier:NCT03509012
EudraCT identifier:2017-002242-77
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)
Medical condition
Carcinoma, squamous cell of head and neck
Phase
Phase 1
Healthy volunteers
No
Study drug
Durvalumab, Tremelimumab, Cisplatin (dose level 4), Cisplatin (dose level 3), Carboplatin (dose level 1), Carboplatin (dose level 2), Etoposide (dose level 1), Etoposide (dose level 2), Paclitaxel, Pemetrexed, Cisplatin (dose level 1), Cisplatin (dose level 2)
Sex
All
Actual Enrollment
105
Study type
Interventional
Age
18 Years - 110 Years
Date
Study Start Date: 02 May 2018
Primary Completion Date: 31 Dec 2020
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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 Name: 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: Durvalumab IV (intravenous) Other Name: MEDI4736 Drug: Carboplatin (dose level 1) IV Drug: Paclitaxel IV Radiation: External beam radiation (dose level 2) radiation therapy |
| Experimental: NSCLC Arm 3 Investigator’s choice of carboplatin and pemetrexed OR cisplatin and pemetrexed | Drug: Durvalumab IV (intravenous) Other Name: MEDI4736 Drug: Carboplatin (dose level 2) IV Drug: Pemetrexed IV Radiation: External beam radiation (dose level 2) radiation therapy 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 Name: MEDI4736 Drug: Cisplatin (dose level 3) IV Drug: Carboplatin (dose level 2) 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 Name: MEDI4736 Drug: Cisplatin (dose level 3) IV Drug: Carboplatin (dose level 2) 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 Name: MEDI4736 Drug: Tremelimumab IV Drug: Cisplatin (dose level 3) IV Drug: Carboplatin (dose level 2) IV Drug: Etoposide (dose level 2) IV Radiation: External beam radiation (standard) radiation therapy |
| 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 Name: MEDI4736 Drug: Tremelimumab IV Drug: Cisplatin (dose level 3) IV Drug: Carboplatin (dose level 2) IV Drug: Etoposide (dose level 2) IV Radiation: External beam radiation (hyperfractionated) radiation therapy |
