Informationen und Ansprechpartner zu CheckRad-CD8
| Studienbeschreibung |
| ESR-16-12356 | CheckRad-CD8 |
| Studientitel | First-line treatment of locally advanced HNSCC with double checkpoint blockade
and radiotherapy dependent on intratumoral CD8+ T cell infiltration (CheckRad-
CD8) |
| Kurzbeschreibung | This is a single arm, open-label, prospective, non-randomized Phase II clinical trial
of locally advanced HNSCC with double checkpoint blockade and radiotherapy
dependent on intratumoral CD8+ T cell Infiltration.
All patients will initially be treated with the PD-L1 inhibitor Durvalumab and the
CTLA-4 Inhibitor Tremelimumab and one cycle with Cisplatin (30mg/m² d1-3) and
Docetaxel (75mg/m² d1). Treatment response will be evaluated clinically by
endoscopy with biopsy. Changes of the CD8+ T cell density in the second biopsy
compared to the first one before therapy will be used for patient selection. Patients
with a stable or decreased CD8+ tumor infiltrating immune cell density or clinical
progressive disease will receive standard CRT outside the trial. For these patients
toxicity will be monitored until the first dose of the subsequent standard CRT.
Patients with an increased CD8+ tumor infiltrating immune cell density and at least
clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor
Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w
including the induction dose) followed by maintenance therapy with Durvalumab (8
additional doses q4w). The primary endpoint is feasibility. Feasibility criteria are
receiving the protocol treatment until cycle 6 of antibody treatment and absence
of any of the DLT defined in the protocol. A feasibility rate of ≥80% is expected.
The efficacy of radioimmunotherapy and predictive character of changes of CD8+
tumor infiltrating immune cells after induction chemo-immunotherapy are further
endpoints. The follow up period will be two years after the completion of
radiotherapy. |
| Betreffendes Organsystem | Kopf-Hals-Tumoren
(Nasentumor, Nasennebenhöhlentumor, Schädelbasis-Tumoren, Kehlkopfkrebs, Mundhöhlenkarzinom, Rachentumor,Speicheldrüsentumor, Schilddrüsenkrebs, Mundhöhlenkarzinom, Zungenkrebs, Lippentumor, Gesichtstumoren, Speicheldrüsentumor, Nasennebenhöhlentumor) |
| Gesamte Studienbeschreibung | https://clinicaltrials.gov/ct2/show/NCT03426657 |
| Studientyp | Therapie-Studie |
| Studienstatus | Rekrutierung offen (Teilnehmer werden aufgenommen) |
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