Squamous Cell Anal Carcinoma Clinical Trial
Official title:
Randomized Phase 2 Trial of Cetuximab and Avelumab or Avelumab Alone for Unresectable, Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (SCCAC) Progressed After at Least One Line of Systemic Treatment
- The standard first line treatment in SCCAC is the association of 5-FU with cisplatin
reaching a percentage of survival at 5 years of about 32% (Faivre 1999); in a recent
case series of patients affected by SCCAC, the combination of 5-FU and cisplatin as
first line treatment produced 34.4% objective response rate (ORR) and a 5 years survival
rate of 15% (Sclafani 2017);
- No standard second line treatment exists for SCCAC;
- Cetuximab in association with irinotecan has demonstrated promising results in
pretreated patients affected by SCCAC (Lukan 2009). In addition, it was recently tested
in stage I-III SCCAC in association with cisplatin plus 5-FU and radiotherapy. Despite
not reaching their pre-specified endpoints both studies reported an interesting activity
in local control of disease, leading to hypothesize that cetuximab warrant further
investigation in new strategies (Garg 2017, Sparano 2017);
- Anti-PD1 treatments such as nivolumab and pembrolizumab showed promising activity in
metastatic refractory SCCAC in terms of response rate and disease control with
acceptable toxicity profiles (Morris 2017, Ott 2017);
- The induction of immunogenic cell death was recently shown for cetuximab-based regimens
(Pozzi 2016) and PD-L1 blockade should lead to NK cells activation enhancing cetuximab
ADCC (Concha-Benavente 2015, Concha-Benavente 2016).
On the basis of these considerations, the investigators designed the present randomized phase
II trial of avelumab alone or avelumab plus cetuximab for previously treated unresectable
locally advanced or metastatic SCCAC.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04894370 -
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
|
Phase 2 |