FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel
NCT03723967 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2024-04-22
Summary
The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.
Conditions
- Squamous Cell Carcinoma of the Head and Neck
Interventions
- DRUG
-
Durvalumab with Carboplatin/Paclitaxel
Durvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy
Sponsors & Collaborators
-
Centre Leon Berard
lead OTHER
Principal Investigators
-
Jérôme FAYETTE, MD · Centre Leon Berard
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-16
- Primary Completion
- 2020-05-16
- Completion
- 2024-03-09
Countries
- France
Study Locations
More Related Trials
-
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC
NCT01864772 ·Status: COMPLETED ·Phase: PHASE2
-
Everolimus, Carboplatin, and Paclitaxel in Locally Advanced Head and Neck Cancer That Cannot Be Removed by Surgery
NCT01333085 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer
NCT03838263 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
NCT02358031 ·Status: COMPLETED ·Phase: PHASE3
-
Feasibility & Efficacy of Durvalumab+Tremelimumab+RT and Durvalumab+RT in Non-resect. Locally Advanced HPVnegativ HNSCC
NCT03624231 ·Status: COMPLETED ·Phase: PHASE2
-
Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
NCT03829722 ·Status: COMPLETED ·Phase: PHASE2
-
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
NCT05057247 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
NCT02262741 ·Status: COMPLETED ·Phase: PHASE1
-
Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment
NCT04875611 ·Status: RECRUITING ·Phase: PHASE2
-
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
NCT03342911 ·Status: COMPLETED ·Phase: PHASE2
-
Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT06725368 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
NCT06385080 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
NCT07061977 ·Status: RECRUITING ·Phase: PHASE3
-
Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT04428333 ·Status: TERMINATED ·Phase: PHASE3
-
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
NCT03258554 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer
NCT04016142 ·Status: TERMINATED ·Phase: PHASE2
-
Maintenance Immune Check-point Inhibitor Following Post-operative Chemo-radiation in Subjects With HPV-negative HNSCC
NCT03673735 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers
NCT04747054 ·Status: RECRUITING ·Phase: PHASE3
-
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
NCT03406247 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma
NCT06199271 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy
NCT00707655 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
NCT03194373 ·Status: COMPLETED ·Phase: PHASE2
-
Durvalumab Plus Tremelimumab Combined With Proton Therapy for HNSCC
NCT03450967 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
NCT03813836 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Nivolumab in Recurrent and/or Metastatic SCCHN
NCT03226756 ·Status: COMPLETED ·Phase: PHASE2