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NCT03723967: FRAIL-IMMUNE
FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel
Phase 2 trial testing Durvalumab with Carboplatin/Paclitaxel in Squamous Cell Carcinoma of the Head and Neck in 104 participants. Completed in 9 March 2024.
16 May 2020
Quick facts
| Lead sponsor | Centre Leon Berard |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 16 May 2019 |
| Primary completion | 16 May 2020 |
| Estimated completion | 9 March 2024 |
| Sites | 17 locations across France |
Drugs / interventions tested
- Durvalumab with Carboplatin/Paclitaxel — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
Sponsor
Centre Leon Berard — full company profile →
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immune Evasion by Head and Neck Cancer: Foundations for Combination Therapy.
Horton JD, Knochelmann HM, Day TA, Paulos CM, et al · · 2019 · cited 65× · PMID 30961829 · DOI 10.1016/j.trecan.2019.02.007 -
A review on the advances and challenges of immunotherapy for head and neck cancer.
Cheng G, Dong H, Yang C, Liu Y, et al · · 2021 · cited 46× · PMID 34332576 · DOI 10.1186/s12935-021-02024-5 -
MicroRNAs in head and neck squamous cell carcinoma: a possible challenge as biomarkers, determinants for the choice of therapy and targets for personalized molecular therapies.
Vahabi M, Blandino G, Di Agostino S. · · 2021 · cited 27× · PMID 35116619 · DOI 10.21037/tcr-20-2530 -
Research Advances in Clinical Applications, Anticancer Mechanism, Total Chemical Synthesis, Semi-Synthesis and Biosynthesis of Paclitaxel.
Zhang S, Ye T, Liu Y, Hou G, et al · · 2023 · cited 26× · PMID 38005238 · DOI 10.3390/molecules28227517 -
A single photodynamic priming protocol augments delivery of ⍺-PD-L1 mAbs and induces immunogenic cell death in head and neck tumors.
Bhandari C, Moffat A, Fakhry J, Malkoochi A, et al · · 2024 · cited 14× · PMID 37818742 · DOI 10.1111/php.13865 -
Safety and preliminary activity of pembrolizumab-carboplatin-paclitaxel in heavily pretreated and/or fragile patients with PDL1-positive recurrent/metastatic head and neck cancer.
Cabezas-Camarero S, Merino-Menéndez S, Cabrera-Martín MN, Sotelo MJ, et al · · 2023 · cited 3× · PMID 36589672 · DOI 10.3892/ol.2022.13623 -
Durvalumab combined with weekly carboplatin/paclitaxel as first-line treatment of patients with recurrent and/or metastatic HNSCC not eligible for cisplatin-based chemotherapies: results of the multicenter prospective study FRAIL-IMMUNE.
Fayette J, Cropet C, Toullec C, Burgy M, et al · · 2026 · PMID 41962312 · DOI 10.1016/j.esmoop.2026.106946
Verify or expand the search:
- PubMed search for NCT03723967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
- NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC · Phase 2 · recruiting
- NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
- NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject · Phase 2 · recruiting
- NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors · Phase 1 · active not recruiting
- NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors · Phase 1 · recruiting
Other Centre Leon Berard trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03723967 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Leon Berard
- Last refreshed: 22 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03723967.
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