Cutaneous Squamous Cell Carcinoma
Conditions
Brief summary
The primary efficacy endpoints for this study are ORR and CRR according to blinded independent review:, ORR/CRR will be determined using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST 1.1) as specified in Appendix 1 for radiologically assessable lesions and clinical and composite response criteria as specified in Appendix 2 for clinically assessable lesions. Confirmatory scans should also be obtained ≥4 weeks following initial documentation of objective response or progressive disease (PD)., In patients suspected of achieving a complete response (CR) by clinical assessment, tumor biopsies may be used in the final determination of CR.
Detailed description
The key secondary outcome measure is PFS by blinded independent review., ORR/CRR by investigator review, ORR/CRR for patients with metastatic (nodal or distant) disease by investigator and BIRC review, ORR/CRR for patients with locally advanced disease by investigator and blinded independent review, ORR/CRR for patients having previously received systemic CSCC-directed therapy by investigator and blinded independent review, ORR/CRR for patients not having previously received systemic CSCC-directed therapy by investigator and blinded independent review, DOR by investigator and blinded independent review, PFS by investigator review, OS, 3-year survival, Change in scores of patient-reported outcomes on EORTC QLQ-C30, To assess the safety and tolerability of cemiplimab alone and combined with RP1
Interventions
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Replimune Group Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoints for this study are ORR and CRR according to blinded independent review:, ORR/CRR will be determined using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST 1.1) as specified in Appendix 1 for radiologically assessable lesions and clinical and composite response criteria as specified in Appendix 2 for clinically assessable lesions. Confirmatory scans should also be obtained ≥4 weeks following initial documentation of objective response or progressive disease (PD)., In patients suspected of achieving a complete response (CR) by clinical assessment, tumor biopsies may be used in the final determination of CR. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary outcome measure is PFS by blinded independent review., ORR/CRR by investigator review, ORR/CRR for patients with metastatic (nodal or distant) disease by investigator and BIRC review, ORR/CRR for patients with locally advanced disease by investigator and blinded independent review, ORR/CRR for patients having previously received systemic CSCC-directed therapy by investigator and blinded independent review, ORR/CRR for patients not having previously received systemic CSCC-directed therapy by investigator and blinded independent review, DOR by investigator and blinded independent review, PFS by investigator review, OS, 3-year survival, Change in scores of patient-reported outcomes on EORTC QLQ-C30, To assess the safety and tolerability of cemiplimab alone and combined with RP1 | — |
Countries
Bulgaria, France, Germany, Greece, Poland, Spain
Outcome results
None listed