Description:
The primary objective is to estimate the objective response rate (ORR) for metastatic Basal
Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when
treated with cemiplimab as a monotherapy
Title
- Brief Title: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
- Official Title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1620
- SECONDARY ID:
2016-003122-16
- NCT ID:
NCT03132636
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| cemiplimab | REGN2810, Libtayo | Group 1- metastatic BCC |
Purpose
The primary objective is to estimate the objective response rate (ORR) for metastatic Basal
Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when
treated with cemiplimab as a monotherapy
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Group 1- metastatic BCC | Experimental | Administration of cemiplimab in accordance with protocol dosing regimen | |
| Group 2 - unresectable locally advanced BCC | Experimental | Administration of cemiplimab in accordance with protocol dosing regimen | |
Eligibility Criteria
Key Inclusion Criteria:
- Confirmed diagnosis of invasive BCC
- Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
therapy
- At least 1 measurable lesion
- ≥18 years of age
- Hepatic function, renal function, bone marrow function in defined lab-value-ranges
- Anticipated life expectancy >12 weeks
- Consent to provide archived tumor biopsy material (all patients)
- Group 2: consent to undergo research biopsies
- Group 2: must not be a candidate for radiation therapy or surgery
- Comply with study procedures and site visits
- Sign Subject Information Sheet and Informed Consent Form
Key Exclusion Criteria:
- Ongoing or recent significant autoimmune disease
- Prior treatment with specific pathway-blockers (PD-1/PD-L1)
- Prior treatment with immune-modulating agents within 28 days before cemiplimab
- Untreated brain metastasis that may be considered active
- Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
treatment with cemiplimab
- Active infections requiring therapy, including HIV, hepatitis
- Pneumonitis within the last 5 years
- Cancer treatment other than radiation therapy, including investigational or standard
of care, within 30 days prior to treatment with cemiplimab
- Documented allergic reactions or similar to antibody treatments
- Concurrent malignancies other than BCC, other than those with negligible risk of
metastases or death
- Any acute or chronic psychiatric problems
- Having received a solid organ transplantation
- Inability to undergo contrast radiological assessments
- Breastfeeding, pregnant, women of childbearing potential not using contraception
Note: Other protocol-defined inclusion/exclusion criteria apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective Response Rate (ORR) for metastatic Basal Cell Carcinoma (BCC) |
| Time Frame: | Baseline to 93 weeks |
| Safety Issue: | |
| Description: | ORR for metastatic BCC measured by RECIST version 1.1 |
Secondary Outcome Measures
| Measure: | Duration of Response (DOR) |
| Time Frame: | Time from the first observed confirmed response to disease progression or death, up to approximately 121 weeks |
| Safety Issue: | |
| Description: | DOR assessed by time from the first observed confirmed response (CR or PR) to disease progression or death, up to approximately 121 weeks (from first response assessment until end of post-treatment follow up) |
| Measure: | Complete Response (CR) Rate |
| Time Frame: | From date of treatment until best objective response of CR after starting cemiplimab, up to approximately 121 weeks |
| Safety Issue: | |
| Description: | CR rate (per central review) assessed from date of treatment until best objective response of CR after starting cemiplimab treatment, up to approximately 121 weeks (from first response assessment until end of post-treatment follow up). |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | From date of treatment until date of death up to approximately 121 weeks |
| Safety Issue: | |
| Description: | PFS assessed from date of treatment until date of death, up to approximately 121 weeks |
| Measure: | Overall Survival (OS) |
| Time Frame: | From date of treatment until date of death, up to approximately 121 weeks |
| Safety Issue: | |
| Description: | OS assessed from date of treatment until date of death, up to approximately 121 weeks |
| Measure: | Change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
| Time Frame: | From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks |
| Safety Issue: | |
| Description: | Change in scores of patient-reported outcomes in EORTC QLQ-C30 assessed from date of treatment until date of first documented progression or date of death, up to approximately 93 weeks |
| Measure: | Change in scores of patient-reported outcomes in Skindex-16 |
| Time Frame: | From date of treatment until date of first documented progression or date of death, up to approximately 93 weeks |
| Safety Issue: | |
| Description: | From date of treatment until date of first documented progression or date of death, assessed up to approximately 93 weeks |
| Measure: | Incidence of treatment emergent adverse events (TEAEs) |
| Time Frame: | Up to week 121 |
| Safety Issue: | |
| Description: | |
| Measure: | Concentration at end of infusion (Ceoi) |
| Time Frame: | Up to week 121 |
| Safety Issue: | |
| Description: | |
| Measure: | Pre-infusion concentration (Ctrough) |
| Time Frame: | Up to week 121 |
| Safety Issue: | |
| Description: | |
| Measure: | Time of end of infusion (teoi) |
| Time Frame: | Up to week 121 |
| Safety Issue: | |
| Description: | |
| Measure: | Anti-cemiplimab antibodies |
| Time Frame: | Up to week 121 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Regeneron Pharmaceuticals |
Last Updated
June 29, 2021
