Study identifier:D933BC00001
ClinicalTrials.gov identifier:NCT03509012
EudraCT identifier:2017-002242-77
CTIS identifier:N/A
A Phase I Multicenter Study of Immunotherapy in Combination with Chemoradiation in Patients with Advanced Solid Tumors (CLOVER)
Carcinoma, squamous cell of head and neck
Phase 1
No
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)
All
105
Interventional
18 Years - 110 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
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 |