NCT03132636CompletedPhase 2
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
Regeneron Pharmaceuticals71 sites in 6 countries138 target enrollmentStarted: June 29, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 138
- Locations
- 71
- Primary Endpoint
- Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR)
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Group 1- metastatic BCC
Experimental
Administration of cemiplimab in accordance with protocol dosing regimen
Intervention: cemiplimab (Drug)
Group 2 - unresectable locally advanced BCC
Experimental
Administration of cemiplimab in accordance with protocol dosing regimen
Intervention: cemiplimab (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR)
Time Frame: Up to 1422 days (approximately 46 months)
ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.
Secondary Outcomes
- Objective Response Rate (ORR) Per Investigator Assessment(Up to 1422 days (approximately 46 months))
- Duration of Response (DOR) as Assessed by ICR(Up to 48 months)
- Duration of Response (DOR) Per Investigator Assessment(Up to 48 months)
- Complete Response (CR) Rate as Assessed by ICR(Up to 48 months)
- Complete Response (CR) Rate Per Investigator Assessment(Up to 48 months)
- Progression Free Survival (PFS) as Assessed by ICR(Up to 60 months)
- Progression Free Survival (PFS) Per Investigator Assessment(Up to 60 months)
- Overall Survival (OS)(Up to 60 months)
- Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]))
- Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire(Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(Up to 1422 days (approximately 46 months))
- Serum Concentration at Pre-infusion (Ctrough)(At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks))
- Serum Concentration at End of Infusion (Cmax)(At end-of-infusion (within 10 minutes after the end of infusion) on Cycle 1 Day 1 and Cycle 3 Day 1 (Each cycle of 9 weeks))
- Number of Participants With Anti-Drug Antibody (ADA) Status(Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks))
Investigators
Study Sites (71)
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